Patient leaflet - Pradaxa

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Pradaxa 75 mg hard capsules dabigatran etexilate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pradaxa is and what it is used for
2. What you need to know before you take Pradaxa
3. How to take Pradaxa
4. Possible side effects
5. How to store Pradaxa
6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot formation.

Pradaxa is used in adults to:

– prevent the formation of blood clots in the veins after knee or hip replacement surgery.

Pradaxa is used in children to:

– treat blood clots and to prevent blood clots from reoccurring.

2. What you need to know before you take Pradaxa

Do not take Pradaxa

– if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
– if you have severely reduced kidney function.
– if you are currently bleeding.
– if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).
– if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines.
– if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open or while your heart beat is being restored to normal by a procedure called catheter ablation for atrial fibrillation.
– if you have a severely reduced liver function or liver disease which could possibly cause death.
– if you are taking oral ketoconazole or itraconazole, medicines to treat fungal infections.
– if you are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation.
– if you are taking dronedarone, a medicine used to treat abnormal heart beat.
– if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C
– if you have received an artificial heart valve which requires permanent blood thinning.

Warnings and precautions

Talk to your doctor before taking Pradaxa. You may also need to talk to your doctor during treatment with this medicine if you experience symptoms or if you have to undergo surgery.

Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:

– if you have an increased bleeding risk, such as:

■ if you have been recently bleeding.
■ if you have had a surgical tissue removal (biopsy) in the past month.
■ if you have had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment).
■ if you are suffering from an inflammation of the gullet or stomach.
■ if you have problems with reflux of gastric juice into the gullet.
■ if you are receiving medicines which could increase the risk of bleeding. See ‚Other medicines and Pradaxa‘ below.
■ if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
■ if you are suffering from an infection of the heart (bacterial endocarditis).
■ if you know you have decreased kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) / foaming urine).
■ if you are older than 75 years.
■ if you are an adult patient and weigh 50 kg or less.
■ only if used for children: if the child has an infection around or within the brain.

– if you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack.
– if you have a liver disease that is associated with changes in the blood tests. The use of this medicine is not recommended in this case.

Take special care with Pradaxa

– if you need to have an operation:

In this case Pradaxa will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation. It is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.

– if an operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

■ it is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
■ tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

– if you fall or injure yourself during treatment, especially if you hit your head. Please seek urgent medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding.
– if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

Other medicines and Pradaxa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular you should tell your doctor before taking Pradaxa , if you are taking one of the medicines listed below:

– Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
– Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin
– Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil).

If you are taking amiodarone, quinidine or verapamil containing medicines, your doctor may tell you to use a reduced dose of Pradaxa depending on the condition for which itis prescribed to you. See also section 3.

– Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
– A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat

hepatitis C)

– Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
– St. John's wort, a herbal medicine for depression
– Antidepressant medicines called selective serotonin re-uptake inhibitors or serotoninnorepinephrine re-uptake inhibitors
– Rifampicin or clarithromycin (two antibiotics)
– Anti-viral medicines for AIDS (e.g. ritonavir)
– Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

The effects of Pradaxa on pregnancy and the unborn child are not known. You should not take this medicine if you are pregnant unless your doctor advises you that it is safe to do so. If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Pradaxa.

You should not breast-feed while you are taking Pradaxa.

Driving and using machines

Pradaxa has no known effects on the ability to drive or use machines.

3. How to take Pradaxa

Pradaxa capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other age appropriate dose forms for the treatment of children below 8 years.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Pradaxa as recommended for the following conditions:

Prevention of blood clot formation after knee or hip replacement surgery

The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).

If your kidney function is decreased by more than half or if you are 75 years of age or older , the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).

If you are taking amiodarone, quinidine or verapamil containing medicines the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).

If you are taking verapamil containing medicines and your kidney function is decreased by more than half, you should be treated with a reduced dose of 75 mg Pradaxa because your bleeding risk may be increased.

For both surgery types, treatment should not be started if there is bleeding from the site of operation. If the treatment cannot be started until the day after surgery, dosing should be started with 2 capsules once a day.

After knee replacement surgery

You should start treatment with Pradaxa within 1–4 hours after surgery finishes, taking a single capsule. Thereafter two capsules once a day should be taken for a total of 10 days.

After hip replacement surgery

You should start treatment with Pradaxa within 1–4 hours after surgery finishes, taking a single capsule. Thereafter two capsules once a day should be taken for a total of 28–35 days.

Treatment of blood clots and prevention of blood clots from reoccurring in children

Pradaxa should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible.

The recommended dose depends on age and weight. Your doctor will determine the correct dose. Your doctor may adjust the dose as treatment progresses. Keep using all other medicines, unless your doctor tells you to stop using any.

Single Pradaxa dose to be given twice daily in milligrams (mg) by weight in kilograms (kg) and age in years of the patient:

Age in years

8 to <9

9 to

<10

10 to 11 to

<11 <12

12 to 13 to

<13 <14

14 to 15 to 16 to 17 to

<15 <16 <17 <18

Weight [kg]

>81		300 mg as two 150 mg capsules or four 75 mg capsules
71 to <81 61 to <71
51 to <61	260 mg as one 110 mg plus one 150 mg capsule or one 110 mg plus two 75 mg capsules
41 to <51	220 mg as two 110 mg capsules
31 to <41	185 mg as one 75 mg plus one 110 mg capsule
26 to <31	150 mg as one 150 mg capsule or two 75 mg capsules
21 to <26
16 to <21	One 110 mg capsule
13 to<16
11 to<13	One 75 mg capsule

Means that no dosing recommendation can be provided.

How to take Pradaxa

Pradaxa can be taken with or without food. The capsule should be swallowed whole with a glass of water, to ensure delivery to the stomach. Do not break, chew, or empty the pellets from the capsule since this may increase the risk of bleeding.

Instructions for opening the blisters

The following pictogram illustrates how to take Pradaxa capsules out of the blister

Tear off one individual blister from the blister card along the perforated line

Peel off the backing foil and remove the capsule.

Do not push the capsules through the blister foil.
Do not peel off the blister foil until a capsule is required.

Instructions for the bottle

Push and turn for opening.
After removing the capsule, place the cap back on the bottle and tightly close the bottle right

away after you take your dose.

Change of anticoagulant treatment

Without specific guidance from your doctor do not change your anticoagulant treatment.

If you take more Pradaxa than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Pradaxa

Prevention of blood clot formation after knee or hip replacement surgery

Continue with your remaining daily doses of Pradaxa at the same time of the next day.

Do not take a double dose to make up for a forgotten dose.

Treatment of blood clots and prevention of blood clots from reoccurring in children

A forgotten dose can still be taken up to 6 hours prior to the next due dose.

A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose. Do not double a dose to make up for a forgotten dose.

If you stop taking Pradaxa

Take Pradaxa exactly as prescribed. Do not stop taking this medicine without talking to your doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early. Contact your doctor if you experience indigestion after taking Pradaxa.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Pradaxa affects blood clotting, so most side effects are related to signs such as bruising or bleeding. Major or severe bleeding may occur, these constitute the most serious side effects and, regardless of location, may become disabling, life-threatening or even lead to death. In some cases these bleedings may not be obvious.

If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your doctor immediately. Your doctor may decide to keep you under closer observation or change your medicine.

Tell your doctor immediately, if you experience a serious allergic reaction which causes difficulty in breathing or dizziness.

Possible side effects are listed below, grouped by how likely they are to happen.

Prevention of blood clot formation after knee or hip replacement surgery

Common (may affect up to 1 in 10 people):

– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– Unusual laboratory test results on liver function

Uncommon (may affect up to 1 in 100 people):

– Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), from piles, from the rectum, under the skin, into a joint, from or after an injury or after an operation
– Haematoma formation or bruising occurring after an operation
– Blood detected in the stools by a laboratory test
– A fall in the number of red cells in the blood
– A decrease in the proportion of blood cells
– Allergic reaction
– Vomiting
– Frequent loose or liquid bowel movements
– Feeling sick
– Wound secretion (liquid exuding from the surgical wound)
– Liver enzymes increased
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Rare (may affect up to 1 in 1,000 people):

– Bleeding
– Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection

or from the site of entry of a catheter into a vein

– Blood-stained discharge from the site of entry of a catheter into a vein
– Coughing of blood or blood stained sputum
– A fall in the number of platelets in the blood
– A fall in the number of red cells in the blood after an operation
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Itching
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Inflammation of the gullet and stomach
– Reflux of gastric juice into the gullet
– Belly ache or stomach ache
– Indigestion
– Difficulty in swallowing
– Fluid exiting a wound
– Fluid exiting a wound after an operation

Not known (frequency cannot be estimated from the available data):

– Difficulty in breathing or wheezing
– Decreases in the number or even lack of white blood cells (which help to fight infections)
– Hair loss

Treatment of blood clots and prevention of blood clots from reoccurring in children

Common (may affect up to 1 in 10 people):

– A fall in the number of red cells in the blood
– A fall in the number of platelets in the blood
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Haematoma formation
– Nosebleed
– Reflux of gastric juice into the gullet
– Vomiting
– Feeling sick
– Frequent loose or liquid bowel movements
– Indigestion
– Hair loss
– Liver enzymes increased

Uncommon (may affect up to 1 in 100 people):

– Decrease in the number of white blood cells (which help to fight infections)
– Bleeding may happen into the stomach or bowel, from the brain, from the rectum, from

penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin

– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– A decrease in the proportion of blood cells
– Itching
– Coughing of blood or blood stained sputum
– Belly ache or stomach ache
– Inflammation of the gullet and stomach
– Allergic reaction
– Difficulty in swallowing
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

– Lack of white blood cells (which help to fight infections)
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Difficulty in breathing or wheezing
– Bleeding
– Bleeding may happen into a joint or from an injury, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein
– Bleeding may happen from piles
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Unusual laboratory test results on liver function

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pradaxa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”. The expiry date refers to the last day of that month.

Blister: Store in the original package in order to protect from moisture.

Bottle: Once opened, the medicine must be used within 4 months. Keep the bottle tightly closed. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pradaxa contains

– The active substance is dabigatran. Each hard capsule contains 75 mg dabigatran etexilate (as mesilate).
– The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and hydroxypropylcellulose.
– The capsule shell contains carrageenan, potassium chloride, titanium dioxide, and hypromellose.
– The black printing ink contains shellac, iron oxide black and potassium hydroxide.

What Pradaxa looks like and contents of the pack

Pradaxa 75 mg are hard capsules (approx. 18 × 6 mm) with an opaque, white cap and an opaque, white body. The Boehringer Ingelheim logo is printed on the cap and “R75” on the body of the hard capsule.

This medicine is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules in aluminium perforated unit dose blisters. Furthermore, Pradaxa is available in packs containing 60 × 1 hard capsules in aluminium perforated unit dose white blisters.

This medicine is also available in polypropylene (plastic) bottles with 60 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

and

Boehringer Ingelheim France

100–104 avenue de France

75013 Paris

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel: +370 5 2595942

Efc^rapufl

EbopuHrep HHrenxaňM PUB R-ioX u Ko. Kr -K.TOH Ebnrapua

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tel/Tel: +32 2 773 33 11

Ten: +359 2 958 79 98

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarorszag

Boehringer Ingelheim RCV GmbH & Co KG

Magyarorszagi Fioktelepe

Tel: +36 1 299 8900

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Tel: +372 612 8000

EXXáSa

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105–7870

España

Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena-Sucursala Bucuresti

Tel: +40 21 302 2800

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Kûnpoç

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiâle

Tel: +371 67 240 011

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

United Kingdom (Northern Ireland)

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Pradaxa 110 mg hard capsules dabigatran etexilate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pradaxa is and what it is used for
2. What you need to know before you take Pradaxa
3. How to take Pradaxa
4. Possible side effects
5. How to store Pradaxa
6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

Pradaxa is used in adults to:

– prevent the formation of blood clots in the veins after knee or hip replacement surgery.
– prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form

of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.

– treat blood clots in the veins of your legs and lungs and to prevent blood clots from re-occurring in the vein of your legs and lungs.

Pradaxa is used in children to:

– treat blood clots and to prevent blood clots from reoccurring.

2. What you need to know before you take Pradaxa

Do not take Pradaxa

– if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
– if you have severely reduced kidney function.
– if you are currently bleeding.
– if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).
– if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines.
– if you are taking medicines to prevent blood clotting (e.g.warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open or while your heart beat is being restored to normal by a procedure called catheter ablation for atrial fibrillation.
– if you have a severely reduced liver function or liver disease which could possibly cause death.
– if you are taking oral ketoconazole or itraconazole, medicines to treat fungal infections.
– if you are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation.
– if you are taking dronedarone, a medicine used to treat abnormal heart beat.
– if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine

used to treat hepatitis C

– if you have received an artificial heart valve which requires permanent blood thinning.

Warnings and precautions

Talk to your doctor before taking Pradaxa. You may also need to talk to your doctor during treatment with this medicine if you experience symptoms or if you have to undergo surgery.

Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:

– if you have an increased bleeding risk, such as:

■ if you have been recently bleeding.
■ if you have had a surgical tissue removal (biopsy) in the past month.
■ if you have had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment).
■ if you are suffering from an inflammation of the gullet or stomach.
■ if you have problems with reflux of gastric juice into the gullet.
■ if you are receiving medicines which could increase the risk of bleeding. See ‚Other medicines and Pradaxa‘ below.
■ if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
■ if you are suffering from an infection of the heart (bacterial endocarditis).
■ if you know you have decreased kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) /foaming urine).
■ if you are older than 75 years.
■ if you are an adult patient and weigh 50 kg or less.
■ only if used for children: if the child has an infection around or within the brain.

– if you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack.
– if you have a liver disease that is associated with changes in the blood tests. The use of this medicine is not recommended in this case.

Take special care with Pradaxa

– if you need to have an operation:

– if an operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

■ it is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
■ tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

– if you fall or injure yourself during treatment, especially if you hit your head. Please seek urgent

medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding.

– if you know that you have a disease called antiphospholipid syndrome (a disorder of the

immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

Other medicines and Pradaxa

– Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
– Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin
– Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking amiodarone, quinidine or verapamil containing medicines, your doctor may tell you to use a reduced dose of Pradaxa depending on the condition for which it is prescribed to you. See section 3.
– Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
– A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat

hepatitis C)

– Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
– St. John's wort, a herbal medicine for depression
– Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin

norepinephrine re-uptake inhibitors

– Rifampicin or clarithromycin (two antibiotics)
– Anti-viral medicines for AIDS (e.g. ritonavir)
– Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

You should not breast-feed while you are taking Pradaxa.

Driving and using machines

Pradaxa has no known effects on the ability to drive or use machines.

3. How to take Pradaxa

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Pradaxa as recommended for the following conditions:

Prevention of blood clot formation after knee or hip replacement surgery

The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg).

If your kidney function is decreased by more than half or if you are 75 years of age or older , the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).

If you are taking amiodarone, quinidine or verapamil containing medicines the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg).

After knee replacement surgery

You should start treatment with Pradaxa within 1–4 hours after surgery finishes, taking a single capsule. Thereafter two capsules once a day should be taken for a total of 10 days.

After hip replacement surgery

You should start treatment with Pradaxa within 1–4 hours after surgery finishes, taking a single capsule. Thereafter two capsules once a day should be taken for a total of 28–35 days.

Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats and Treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the vein of your legs and lungs

The recommended dose is 300 mg taken as one 150 mg capsule twice a day.

If you are 80 years or older , the recommended dose is 220 mg taken as one 110 mg capsule twice a day.

If you are taking verapamil containing medicines , you should be treated with a reduced Pradaxa dose of 220 mg taken as one 110 mg capsule twice a day , because your bleeding risk may be increased.

If you have a potentially higher risk for bleeding , your doctor may decide to prescribe a dose of 220 mg taken as one 110 mg capsule twice a day.

You can continue to take this medicine if your heart beat needs to be restored to normal by a procedure called cardioversion. Take Pradaxa as your physician has told you.

If a medical device (stent) has been deployed in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with stenting, you can be treated with Pradaxa after your physician has decided that normal control of blood coagulation is achieved. Take Pradaxa as your physician has told you.

Treatment of blood clots and prevention of blood clots from reoccurring in children

Pradaxa should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible.

Single Pradaxa dose to be given twice daily in milligrams (mg) by weight in kilograms (kg) and age in years of the patient:

6/j

Age in years

	8 to <9 9 to <10	10 to 11 to 12 to 13 to 14 to 15 to 16 to 17 to <11 <12 <13 <14 <15 <16 <17 <18
>81		300 mg
71 to <81		as two 150 mg capsules
61 to <71	or four 75 mg capsules
51 to <61	260 mg as one 110 mg plus one 150 mg capsule or

one 110 mg plus two 75 mg capsules

220 mg

______as two 110 mg capsules ______

185 mg

41 to <51

31 to <41

26 to <31

21 to <26

16 to <21

13 to<16

11 to <13

as one 75 mg plus one 110 mg capsule

150 mg

as one 150 mg capsule

Means that no dosing recommendation can be provided.

How to take Pradaxa

Instructions for opening the blisters

The following pictogram illustrates how to take Pradaxa capsules out of the blister

Tear off one individual blister from the blister card along the perforated line

Peel off the backing foil and remove the capsule.

Do not push the capsules through the blister foil.
Do not peel off the blister foil until a capsule is required.

Instructions for the bottle

Push and turn for opening.
After removing the capsule, place the cap back on the bottle and tightly close the bottle right

away after you take your dose.

Change of anticoagulant treatment

Without specific guidance from your doctor do not change your anticoagulant treatment.

If you take more Pradaxa than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Pradaxa

Prevention of blood clot formation after knee or hip replacement surgery

Continue with your remaining daily doses of Pradaxa at the same time of the next day.

Do not take a double dose to make up for a forgotten dose.

Use in adults: Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats and treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the vein of your legs and lungs

Use in children: Treatment of blood clots and prevention of blood clots from reoccurring

A forgotten dose can still be taken up to 6 hours prior to the next due dose.

A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose.

Do not double a dose to make up for a forgotten dose.

If you stop taking Pradaxa

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, if you experience a serious allergic reaction which causes difficulty in breathing or dizziness.

Possible side effects are listed below, grouped by how likely they are to happen.

Prevention of blood clot formation after knee or hip replacement surgery

Common (may affect up to 1 in 10 people):

– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– Unusual laboratory test results on liver function

Uncommon (may affect up to 1 in 100 people):

– Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary

tract (incl. blood in the urine that stains the urine pink or red), from piles, from the rectum, under the skin, into a joint, from or after an injury or after an operation

– Haematoma formation or bruising occurring after an operation
– Blood detected in the stools by a laboratory test
– A fall in the number of red cells in the blood
– A decrease in the proportion of blood cells
– Allergic reaction
– Vomiting
– Frequent loose or liquid bowel movements
– Feeling sick
– Wound secretion (liquid exuding from the surgical wound)
– Liver enzymes increased
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Rare (may affect up to 1 in 1,000 people):

– Bleeding
– Bleeding may happen in the brain, from a surgical incision, from the site of entry of an injection

or from the site of entry of a catheter into a vein

– Blood-stained discharge from the site of entry of a catheter into a vein
– Coughing of blood or blood stained sputum
– A fall in the number of platelets in the blood
– A fall in the number of red cells in the blood after an operation
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Itching
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Inflammation of the gullet and stomach
– Reflux of gastric juice into the gullet
– Belly ache or stomach ache
– Indigestion
– Difficulty in swallowing
– Fluid exiting a wound
– Fluid exiting a wound after an operation

Not known (frequency cannot be estimated from the available data):

– Difficulty in breathing or wheezing
– Decreases in the number or even lack of white blood cells (which help to fight infections)

Hair loss

Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats

Common (may affect up to 1 in 10 people):

– Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin
– A fall in the number of red cells in the blood
– Belly ache or stomach ache
– Indigestion
– Frequent loose or liquid bowel movements
– Feeling sick

Uncommon (may affect up to 1 in 100 people):

– Bleeding
– Bleeding may happen from piles, from the rectum, or in the brain.
– Haematoma formation
– Coughing of blood or blood stained sputum
– A fall in the number of platelets in the blood
– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– Allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Itching
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Inflammation of the gullet and stomach
– Reflux of gastric juice into the gullet
– Vomiting
– Difficulty in swallowing
– Unusual laboratory test results on liver function

Rare (may affect up to 1 in 1,000 people):

– Bleeding may happen into a joint, from a surgical incision, from an injury, from the site of entry

of an injection or from the site of entry of a catheter into a vein

– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– A decrease in the proportion of blood cells
– Liver enzymes increased
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

– Difficulty in breathing or wheezing
– Decreases in the number or even lack of white blood cells (which help to fight infections)
– Hair loss

In a clinical trial the rate of heart attacks with Pradaxa was numerically higher than with warfarin. The overall occurence was low.

Treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the veins of your legs and/or lungs

Common (may affect up to 1 in 10 people):

– Bleeding may happen from the nose, into the stomach or bowel, from the rectum, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin
– Indigestion

Uncommon (may affect up to 1 in 100 people):

– Bleeding
– Bleeding may happen into a joint or from an injury
– Bleeding may happen from piles
– A fall in the number of red cells in the blood
– Haematoma formation
– Coughing of blood or blood stained sputum
– Allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Itching
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Inflammation of the gullet and stomach
– Reflux of gastric juice into the gullet
– Feeling sick
– Vomiting
– Belly ache or stomach ache
– Frequent loose or liquid bowel movements
– Unusual laboratory test results on liver function
– Liver enzymes increased

Rare (may affect up to 1 in 1,000 people):

– Bleeding may happen, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein or from the brain
– A fall in the number of platelets in the blood
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Difficulty in swallowing

Not known (frequency cannot be estimated from the available data):

– Difficulty in breathing or wheezing
– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– A decrease in the proportion of blood cells
– Decreases in the number or even lack of white blood cells (which help to fight infections)
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems
– Hair loss

In the trial program the rate of heart attacks with Pradaxa was higher than with warfarin. The overall occurence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran versus patients treated with placebo.

Treatment of blood clots and prevention of blood clots from reoccurring in children

Common (may affect up to 1 in 10 people):

– A fall in the number of red cells in the blood
– A fall in the number of platelets in the blood
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Haematoma formation
– Nosebleed
– Reflux of gastric juice into the gullet
– Vomiting
– Feeling sick
– Frequent loose or liquid bowel movements
– Indigestion
– Hair loss
– Liver enzymes increased

Uncommon (may affect up to 1 in 100 people):

– Decrease in the number of white blood cells (which help to fight infections)
– Bleeding may happen into the stomach or bowel, from the brain, from the rectum, from

penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin

– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– A decrease in the proportion of blood cells
– Itching
– Coughing of blood or blood stained sputum
– Belly ache or stomach ache
– Inflammation of the gullet and stomach
– Allergic reaction
– Difficulty in swallowing
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

– Lack of white blood cells (which help to fight infections)
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Difficulty in breathing or wheezing
– Bleeding
– Bleeding may happen into a joint or from an injury, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein
– Bleeding may happen from piles
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Unusual laboratory test results on liver function

Reporting of side effects

5. How to store Pradaxa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”. The expiry date refers to the last day of that month.

Blister: Store in the original package in order to protect from moisture.

Bottle: Once opened, the medicine must be used within 4 months. Keep the bottle tightly closed. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pradaxa contains

– The active substance is dabigatran. Each hard capsule contains 110 mg dabigatran etexilate (as mesilate).
– The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and hydroxypropylcellulose.
– The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, and hypromellose.
– The black printing ink contains shellac, iron oxide black and potassium hydroxide.

What Pradaxa looks like and contents of the pack

Pradaxa 110 mg are hard capsules (approx. 19 × 7 mm) with an opaque, light blue-coloured cap and an opaque, light blue -coloured body. The Boehringer Ingelheim logo is printed on the cap and “R110” on the body of the hard capsule.

This medicine is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules, a multipack containing 3 packs of 60 × 1 hard capsules (180 hard capsules) or a multipack containing 2 packs of 50 × 1 hard capsules (100 hard capsules) in aluminium perforated unit dose blisters. Furthermore, Pradaxa is available in packs containing 60 × 1 hard capsules in aluminium perforated unit dose white blisters.

This medicine is also available in polypropylene (plastic) bottles with 60 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

and

Boehringer Ingelheim France

100–104 avenue de France

75013 Paris

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel: +370 5 2595942

Efc^rapufl

EbopuHrep HHrenxaňM PUB FmoX u Ko. Kr -K.TOH Ebnrapua

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tel/Tel: +32 2 773 33 11

Ten: +359 2 958 79 98

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarorszag

Boehringer Ingelheim RCV GmbH & Co KG

Magyarorszagi Fioktelepe

Tel: +36 1 299 8900

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Tel: +372 612 8000

EXXáSa

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105–7870

España

Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena-Sucursala Bucuresti

Tel: +40 21 302 2800

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Kûnpoç

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiâle

Tel: +371 67 240 011

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

United Kingdom (Northern Ireland)

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Pradaxa 150 mg hard capsules dabigatran etexilate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pradaxa is and what it is used for
2. What you need to know before you take Pradaxa
3. How to take Pradaxa
4. Possible side effects
5. How to store Pradaxa
6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

Pradaxa is used in adults to:

– prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
– treat blood clots in the veins of your legs and lungs and to prevent blood clots from re-occurring in the vein of your legs and lungs.

Pradaxa is used in children to:

– treat blood clots and to prevent blood clots from reoccurring.

2. What you need to know before you take Pradaxa

Do not take Pradaxa

– if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
– if you have severely reduced kidney function.
– if you are currently bleeding.
– if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).
– if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines.
– if you are taking medicines to prevent blood clotting (e.g.warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open or while your heart beat is being restored to normal by a procedure called catheter ablation for atrial fibrillation.
– if you have a severely reduced liver function or liver disease which could possibly cause death.
– if you are taking oral ketoconazole or itraconazole, medicines to treat fungal infections.
– if you are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation.
– if you are taking dronedarone, a medicine used to treat abnormal heart beat.
– if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine

used to treat hepatitis C

– if you have received an artificial heart valve which requires permanent blood thinning.

Warnings and precautions

Talk to your doctor before taking Pradaxa. You may also need to talk to your doctor during treatment with this medicine if you experience symptoms or if you have to undergo surgery.

Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list:

– if you have an increased bleeding risk, such as:

■ if you have been recently bleeding.
■ if you have had a surgical tissue removal (biopsy) in the past month.
■ if you have had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment).
■ if you are suffering from an inflammation of the gullet or stomach.
■ if you have problems with reflux of gastric juice into the gullet.
■ if you are receiving medicines which could increase the risk of bleeding. See ‚Other medicines and Pradaxa‘ below.
■ if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
■ if you are suffering from an infection of the heart (bacterial endocarditis).
■ if you know you have decreased kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) / foaming urine).
■ if you are older than 75 years.
■ if you are an adult patient and weigh 50 kg or less.
■ only if used for children: if the child has an infection around or within the brain.

– if you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack.
– if you have a liver disease that is associated with changes in the blood tests. The use of this medicine is not recommended in this case.

Take special care with Pradaxa

– if you need to have an operation:

– if an operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

■ it is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.
■ tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.

– if you fall or injure yourself during treatment, especially if you hit your head. Please seek urgent

medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding.

– if you know that you have a disease called antiphospholipid syndrome (a disorder of the

immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.

Other medicines and Pradaxa

– Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
– Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin
– Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil). If you are taking verapamil containing medicines, your doctor may tell you to use a reduced dose of Pradaxa depending on the condition for which it is prescribed to you. See section 3.
– Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
– A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat

hepatitis C)

– Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
– St. John's wort, a herbal medicine for depression
– Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin

norepinephrine re-uptake inhibitors

– Rifampicin or clarithromycin (two antibiotics)
- Anti-viral medicines for AIDS (e.g. ritonavir)
- Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

You should not breast-feed while you are taking Pradaxa.

Driving and using machines

Pradaxa has no known effects on the ability to drive or use machines.

3. How to take Pradaxa

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Pradaxa as recommended for the following conditions:

The recommended dose is 300 mg taken as one 150 mg capsule twice a day.

If you are 80 years or older , the recommended dose is 220 mg taken as one 110 mg capsule twice daily.

If you have a potentially higher risk for bleeding , your doctor may decide to prescribe a dose of 220 mg taken as one 110 mg capsule twice a day.

You can continue to take this medicine if your heart beat needs to be restored to normal by a procedure called cardioversion or by a procedure called catheter ablation for atrial fibrillation. Take Pradaxa as your physician has told you.

Treatment of blood clots and prevention of blood clots from reoccurring in children

Pradaxa should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible.

Single Pradaxa dose to be given twice daily in milligrams (mg) by weight in kilograms (kg) and age in years of the patient:

Age in years

8 to <9

9 to

<10

10 to 11 to

<11 <12

12 to 13 to

<13 <14

14 to 15 to 16 to 17 to

<15 <16 <17 <18

Weight [kg]

>81		300 mg as two 150 mg capsules or four 75 mg capsules
71 to <81 61 to <71
51 to <61	260 mg as one 110 mg plus one 150 mg capsule or one 110 mg plus two 75 mg capsules
41 to <51	220 mg as two 110 mg capsules
31 to <41	185 mg as one 75 mg plus one 110 mg capsule
26 to <31	150 mg as one 150 mg capsule or two 75 mg capsules
21 to <26
16 to <21	One 110 mg capsule
13 to<16
11 to<13	One 75 mg capsule

Means that no dosing recommendation can be provided.

How to take Pradaxa

Instructions for opening the blisters

The following pictogram illustrates how to take Pradaxa capsules out of the blister

Tear off one individual blister from the blister card along the perforated line

Peel off the backing foil and remove the capsule.

Do not push the capsules through the blister foil.
Do not peel off the blister foil until a capsule is required.

Instructions for the bottle

Push and turn for opening.
After removing the capsule, place the cap back on the bottle and tightly close the bottle right

away after you take your dose.

Change of anticoagulant treatment

Without specific guidance from your doctor do not change your anticoagulant treatment.

If you take more Pradaxa than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Pradaxa

A forgotten dose can still be taken up to 6 hours prior to the next due dose.

A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose. Do not double a dose to make up for a forgotten dose.

If you stop taking Pradaxa

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, if you experience a serious allergic reaction which causes difficulty in breathing or dizziness.

Possible side effects are listed below, grouped by how likely they are to happen.

Prevention of brain or body vessel obstruction by blood clot formation developing after abnormal heart beats

Common (may affect up to 1 in 10 people):

– Bleeding may happen from the nose, into the stomach or bowel, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin
– A fall in the number of red cells in the blood
– Belly ache or stomach ache

– Indigestion
– Frequent loose or liquid bowel movements
– Feeling sick

Uncommon (may affect up to 1 in 100 people):

– Bleeding
– Bleeding may happen from piles, from the rectum, or in the brain.
– Haematoma formation
– Coughing of blood or blood stained sputum
– A fall in the number of platelets in the blood
– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– Allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Itching
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Inflammation of the gullet and stomach
– Reflux of gastric juice into the gullet
– Vomiting
– Difficulty in swallowing
– Unusual laboratory test results on liver function

Rare (may affect up to 1 in 1,000 people):

– Bleeding may happen into a joint, from a surgical incision, from an injury, from the site of entry of an injection or from the site of entry of a catheter into a vein
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– A decrease in the proportion of blood cells
– Liver enzymes increased
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

– Difficulty in breathing or wheezing
– Decreases in the number or even lack of white blood cells (which help to fight infections)
– Hair loss

In a clinical trial the rate of heart attacks with Pradaxa was numerically higher than with warfarin. The overall occurence was low.

Treatment of blood clots in the veins of your legs and lungs including prevention of blood clots from re-occurring in the veins of your legs and/or lungs

Common (may affect up to 1 in 10 people):

– Bleeding may happen from the nose, into the stomach or bowel, from the rectum, from penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin
– Indigestion

Uncommon (may affect up to 1 in 100 people):

– Bleeding
– Bleeding may happen into a joint or from an injury
– Bleeding may happen from piles
– A fall in the number of red cells in the blood
– Haematoma formation
– Coughing of blood or blood stained sputum
– Allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Itching
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Inflammation of the gullet and stomach
– Reflux of gastric juice into the gullet
– Feeling sick
– Vomiting
– Belly ache or stomach ache
– Frequent loose or liquid bowel movements
– Unusual laboratory test results on liver function
– Liver enzymes increased

Rare (may affect up to 1 in 1,000 people):

– Bleeding may happen, from a surgical incision,or from the site of entry of an injection or from the site of entry of a catheter into a vein or from the brain
– A fall in the number of platelets in the blood
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Difficulty in swallowing

Not known (frequency cannot be estimated from the available data):

– Difficulty in breathing or wheezing
– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– A decrease in the proportion of blood cells
– Decreases in the number or even lack of white blood cells (which help to fight infections)
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems
– Hair loss

Treatment of blood clots and prevention of blood clots from reoccurring in children

Common (may affect up to 1 in 10 people):

– A fall in the number of red cells in the blood
– A fall in the number of platelets in the blood
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Haematoma formation
– Nosebleed
– Reflux of gastric juice into the gullet
– Vomiting
– Feeling sick
– Frequent loose or liquid bowel movements
– Indigestion
– Hair loss
– Liver enzymes increased

Uncommon (may affect up to 1 in 100 people):

– Decrease in the number of white blood cells (which help to fight infections)
– Bleeding may happen into the stomach or bowel, from the brain, from the rectum, from

penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin

– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– A decrease in the proportion of blood cells
– Itching
– Coughing of blood or blood stained sputum
– Belly ache or stomach ache
– Inflammation of the gullet and stomach
– Allergic reaction
– Difficulty in swallowing
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

– Lack of white blood cells (which help to fight infections)
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Difficulty in breathing or wheezing
– Bleeding
– Bleeding may happen into a joint or from an injury, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein
– Bleeding may happen from piles
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Unusual laboratory test results on liver function

Reporting of side effects

5. How to store Pradaxa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”. The expiry date refers to the last day of that month.

Blister: Store in the original package in order to protect from moisture.

Bottle: Once opened, the medicine must be used within 4 months. Keep the bottle tightly closed.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pradaxa contains

– The active substance is dabigatran. Each hard capsule contains 150 mg dabigatran etexilate (as mesilate).
– The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and hydroxypropylcellulose.
– The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, and hypromellose.
– The black printing ink contains shellac, iron oxide black and potassium hydroxide.

What Pradaxa looks like and contents of the pack

Pradaxa 150 mg are hard capsules (approx. 22 × 8 mm) with an opaque, light blue-coloured cap and an opaque, white body. The Boehringer Ingelheim logo is printed on the cap and “R150” on the body of the hard capsule.

This medicine is also available in polypropylene (plastic) bottles with 60 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

and

Boehringer Ingelheim France

100–104 avenue de France

75013 Paris

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel: +370 5 2595942

Efc^rapufl

EbopuHrep HHrenxaňM PUB FmoX u Ko. Kr -K.TOH Ebnrapua

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tel/Tel: +32 2 773 33 11

Ten: +359 2 958 79 98

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarorszag

Boehringer Ingelheim RCV GmbH & Co KG

Magyarorszagi Fioktelepe

Tel: +36 1 299 8900

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Tel: +372 612 8000

EXXáSa

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105–7870

España

Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena-Sucursala Bucuresti

Tel: +40 21 302 2800

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Kûnpoç

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiâle

Tel: +371 67 240 011

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

United Kingdom (Northern Ireland)

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Pradaxa 20 mg coated granules

Pradaxa 30 mg coated granules

Pradaxa 40 mg coated granules

Pradaxa 50 mg coated granules

Pradaxa 110 mg coated granules

Pradaxa 150 mg coated granules dabigatran etexilate

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your child’s doctor or pharmacist.
– This medicine has been prescribed for your child only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as your child’s.

– If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pradaxa is and what it is used for
2. What you need to know before your child takes Pradaxa
3. How to take Pradaxa
4. Possible side effects
5. How to store Pradaxa
6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

Pradaxa is used in children to treat blood clots and to prevent blood clots from reoccurring.

2. What you need to know before your child takes Pradaxa

Do not use Pradaxa

– if your child is allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
– if your child has severely reduced kidney function.
– if your child is currently bleeding.
– if your child has a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).
– if your child has an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines.
– if your child is given medicines to prevent blood clotting (e.g.warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment or while having a venous or arterial line and your child gets heparin through this line to keep it open.
– if your child has a severely reduced liver function or liver disease which could possibly cause death.
– if your child is given oral ketoconazole or itraconazole, medicines to treat fungal infections.
– if your child is given oral cyclosporine, a medicine to prevent organ rejection after transplantation.
– if your child is given dronedarone, a medicine used to treat abnormal heart beat.
– if your child is given a combination product of glecaprevir and pibrentasvir, an antiviral

medicine used to treat hepatitis C

– if your child has received an artificial heart valve which requires permanent blood thinning.

Warnings and precautions

Talk to your child’s doctor before you give your child Pradaxa. You may also need to talk to your child’s doctor during treatment with this medicine if your child experiences symptoms or if your child has to undergo surgery.

Tell your child’s doctor if your child has or has had any medical conditions or illnesses, in particular any of those included in the following list:

– if your child has an increased bleeding risk, such as:

■ if your child has been recently bleeding.
■ if your child has had a surgical tissue removal (biopsy) in the past month.
■ if your child has had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment).
■ if your child is suffering from an inflammation of the gullet or stomach.
■ if your child has problems with reflux of gastric juice into the gullet.
■ if your child is receiving medicines which could increase the risk of bleeding. See ‚Other medicines and Pradaxa‘ below.
■ if your child is given anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
■ if your child is suffering from an infection of the heart (bacterial endocarditis).
■ if you know your child has decreased kidney function, or your child is suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) / foaming urine).
■ if your child has an infection around or within the brain.

– if your child has had a heart attack orif your child has been diagnosed with conditions that increase the risk to develop a heart attack.
– if your child has a liver disease that is associated with changes in the blood tests. The use of this medicine is not recommended in this case.

Take special care with Pradaxa

– if your child needs to have an operation:

In this case Pradaxa will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation. It is very important to give Pradaxa before and after the operation exactly at the times you have been told by your child’s doctor.

– if an operation involves a catheter or injection into your child’s spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

■ it is very important to give Pradaxa before and after the operation exactly at the times you have been told by your child’s doctor.
■ tell your child’s doctor immediately if your child gets numbness or weakness of the legs or problems with his/her bowel or bladder after the end of anaesthesia, because urgent care is necessary.

– if your child falls or injures himself/herself during treatment, especially if your child hits his/her head. Please seek urgent medical attention. Your child may need to be checked by a doctor, as your child may be at increased risk of bleeding.
– if you know that your child has a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your child’s doctor who will decide if the treatment may need to be changed.

Other medicines and Pradaxa

Tell your child’s doctor or pharmacist if your child is given or has recently been given other medicines. In particular you should tell your child’s doctor before taking Pradaxa , if your child is given one of the medicines listed below:

– Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
– Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin
– Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil).
– Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
– A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat

hepatitis C)

– Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
– St. John's wort, a herbal medicine for depression
– Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin

norepinephrine re-uptake inhibitors

– Rifampicin or clarithromycin (two antibiotics)
– Anti-viral medicines for AIDS (e.g. ritonavir)
– Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pradaxa with food and drink

Do not mix Pradaxa coated granules with milk or soft food containing milk products. Only use this medicine with apple juice or one of the soft foods mentioned in the instructions for use at the end of the package leaflet.

Pregnancy and breast-feeding

This medicine is intended to be used in children below the age of 12 years. Information regarding pregnancy and breast-feeding may not be relevant in the context of your child’s treatment.

The effects of Pradaxa on pregnancy and the unborn child are not known. A pregnant woman should not take this medicine unless her doctor advises her that it is safe to do so. A woman of child-bearing age should avoid becoming pregnant while she is taking Pradaxa.

Breast-feeding should be stopped during treatment with Pradaxa.

Driving and using machines

Pradaxa has no known effects on the ability to drive or use machines.

3. How to take Pradaxa

Pradaxa coated granules can be used for children below 12 years as soon as they are able to swallow soft food. There are other age appropriate dose forms for the treatment of babies below 12 months and children aged 8 years or older.

Always give this medicine exactly as your child’s doctor has told you. Check with your child’s doctor if you are not sure.

Pradaxa should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible.

The recommended dose depends on age and weight. Your child’s doctor will determine the correct dose for your child based on your child’s age and weight. Your child’s doctor may adjust the dose as treatment progresses. Your child must keep using all other medicines, unless your child’s doctor tells you to stop using any.

Single Pradaxa dose to be given twice daily in milligrams (mg) for patients aged less than 2.5 years. The dose depends on weight in kilograms (kg) and age in months or years of the patient:

Age in months Age in years

Weight [kg]

	0 to <1	1 to <3	3 to <4	4 to <5	5 to <6	6 to <8	8 to <9	9 to <10	10 to <11	11 to <12	1 to <1.5	1.5 to <2	2 to <2.5
21 to <26												140	180
16 to <21											110	110	140
13 to <16									80	100	100	110	140
11 to <13	\|\|\|\|H						70	70	80	80	80	100	100
9 to <11					50	60	60	60	60	70	70	80	80
7 to <9			40	50	50	50	50	60	60	60	60	60	70
5 to <7	20	20	40	40	40	40	50	50	50	50	50	50
4 to <5		20	20	20	20	40	40	40
3 to <4			20	20	20
2.5 to <3				20

Convenient sachet combinations to achieve the single doses recommended in the dosing table are provided below. Other combinations are possible.

20: One 20 mg sachet 80: Two 40 mg sachets
40: One 40 mg sachet 100: Two 50 mg sachets
50: One 50 mg sachet 110: One 110 mg sachet
60: Two 30 mg sachets 140: One 30 mg plus one 110 mg sachet
70: O ne 30 mg plus one 40 mg sachet 180: One 30 mg plus one 150 mg sachet

Means that no dosing recommendation can be provided.

Single Pradaxa dose to be given twice daily in milligrams (mg) for patients aged 2.5 years to

<12 years. The dose depends on weight in kilograms (kg) and age in years of the patient:

Age in years

Weight [kg]

	2.5 to <4	4 to <5	5 to <6	6 to <7	7 to <9	9 to <10	10 to <12
>81							330
71 to <81					330	330	330
61 to <71				330	330	330	330
51 to <61			300	300	300	300	300
41 to <51		260	260	260	260	260	260
31 to <41	190	190	190	190	190	190	190
26 to <31	180	180	180	180	180	180	180
21 to <26	180	180	180	180	180	180	180
16 to <21	140	140	140	140	140	140	140
13 to <16	140	140	140	140	140	140	140
11 to <13	110	110	110	110	110
9 to <11	80	80	80	80
7 to <9	70
Convenient sachet combinations to achieve the singl					e doses recommended in t		he dosing

table are provided below. Other combinations are possible.

180: One 30 mg plus one 150 mg sachet

Means that no dosing recommendation can be provided.

Method and route of administration

This medicine is given together with apple juice or one of the soft food options mentioned in the instructions for use. Do not mix this medicine with milk or soft food containing milk products.

Detailed instructions for the use of this medicine are provided in ‘Instructions for use’ at the end of the package leaflet.

Change of anticoagulant treatment

Without specific guidance from your child’s doctor do not change your child’s anticoagulant treatment.

If you give more Pradaxa than you should

Taking too much of this medicine increases the risk of bleeding. Contact your child’s doctor immediately if you have given too much of it. Specific treatment options are available.

If you forget to give your child Pradaxa

A forgotten dose can still be given up to 6 hours prior to the next due dose.

A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose.

Do not give a double dose to make up for a forgotten dose.

If a dose has only been taken partially, do not attempt to administer a second dose at that time-point. Give the next dose as scheduled approximately 12 hours later.

If you stop giving Pradaxa

Give Pradaxa exactly as prescribed. Do not stop giving this medicine without talking to your child’s doctor first, because the risk of developing a blood clot could be higher if you stop treatment too early. Contact your child’s doctor if your child experiences indigestion after giving Pradaxa.

If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If your child experiences any bleeding event that does not stop by itself or if your child experiences signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) consult your child’s doctor immediately. Your child’s doctor may decide to keep your child under closer observation or change the medicine.

Tell your child’s doctor immediately, if your child experiences a serious allergic reaction which causes difficulty in breathing or dizziness.

Possible side effects are listed below, grouped by how likely they are to happen.

Common (may affect up to 1 in 10 people):

– A fall in the number of red cells in the blood
– A fall in the number of platelets in the blood
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Haematoma formation
– Nosebleed
– Reflux of gastric juice into the gullet
– Vomiting
– Feeling sick
– Frequent loose or liquid bowel movements
– Indigestion
– Hair loss
– Liver enzymes increased

Uncommon (may affect up to 1 in 100 people):

– Decrease in the number of white blood cells (which help to fight infections)
– Bleeding may happen into the stomach or bowel, from the brain, from the rectum, from

penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin

– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– A decrease in the proportion of blood cells
– Itching
– Coughing of blood or blood stained sputum
– Belly ache or stomach ache
– Inflammation of the gullet and stomach
– Allergic reaction
– Difficulty in swallowing
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

– Lack of white blood cells (which help to fight infections)
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Difficulty in breathing or wheezing
– Bleeding
– Bleeding may happen into a joint or from an injury, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein
– Bleeding may happen from piles
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Unusual laboratory test results on liver function

Reporting of side effects

If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pradaxa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Before first use, do not open the aluminium bag containing the sachets with the Pradaxa coated granules in order to protect from moisture.

Once the aluminium bag containing the sachets with the coated granules and the desiccant is opened, the medicine must be used within 6 months. The opened sachet cannot be stored and must be used immediately after opening.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pradaxa contains

– The active substance is dabigatran. Each sachet of Pradaxa 20 mg coated granules contains coated granules with 20 mg dabigatran etexilate (as mesilate).
– The active substance is dabigatran. Each sachet of Pradaxa 30 mg coated granules contains coated granules with 30 mg dabigatran etexilate (as mesilate).
– The active substance is dabigatran. Each sachet of Pradaxa 40 mg coated granules contains coated granules with 40 mg dabigatran etexilate (as mesilate).
– The active substance is dabigatran. Each sachet of Pradaxa 50 mg coated granules contains coated granules with 50 mg dabigatran etexilate (as mesilate).
– The active substance is dabigatran. Each sachet of Pradaxa 110 mg coated granules contains coated granules with 110 mg dabigatran etexilate (as mesilate).
– The active substance is dabigatran. Each sachet of Pradaxa 150 mg coated granules contains coated granules with 150 mg dabigatran etexilate (as mesilate).
– The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc and hydroxypropylcellulose.

What Pradaxa looks like and contents of the pack

The sachets of Pradaxa coated granules contain yellowish coated granules.

Each pack of this medicine contains an aluminium bag which in turn contains 60 silver-coloured aluminium sachets with Pradaxa coated granules and a desiccant (labelled “DO NOT EAT” including pictogram and “SILICA GEL”).

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

70: One 30 mg plus one 40 mg sachet

80: Two 40 mg sachets

110: One 110 mg sachet

140: One 30 mg plus one 110 mg sachet

190: One 40 mg plus one 150 mg sachet

260: One 110 mg plus one 150 mg sachet

300: Two 150 mg sachets

330: Three 110 mg sachets

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel: +370 5 2595942

Efc^rapufl

EbopuHrep HHrenxaňM PUB R-ioX u Ko. Kr -K.TOH Ebnrapua

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tel/Tel: +32 2 773 33 11

Ten: +359 2 958 79 98

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarorszag

Boehringer Ingelheim RCV GmbH & Co KG

Magyarorszagi Fioktelepe

Tel: +36 1 299 8900

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Tel: +372 612 8000

EXXáSa

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105–7870

España

Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena-Sucursala Bucuresti

Tel: +40 21 302 2800

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Kvnpog

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiäle

Tel: +371 67 240 011

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

United Kingdom (Northern Ireland)

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

Instructions for use

Do not administer Pradaxa coated granules

via syringes or feeding tubes
with other than the soft foods or apple juice as indicated below

Administer Pradaxa coated granules either with soft foods or apple juice. The instructions are provided below under A) for soft foods and B) for apple juice.

The prepared medicine should be given before meals in order to ensure that the patient takes the full dose.

Administer the prepared medicine to the patient immediately or within 30 minutes after mixing. Do not give this medicine if it has been in contact with the food or apple juice for more than 30 minutes.

In case of an incomplete intake of the prepared medicine, do not apply a second dose, wait until the next dosing time-point.

A) Administration of Pradaxa coated granules with soft foods

The food should be at room temperature before mixing with the coated granules. The medicine can be administered with one of the following soft foods:

Mashed carrots
Apple sauce (for administration with apple juice see B))
Mashed banana

Do not use soft food containing milk products.

Step 1 – Prepare cup or bowl

Transfer two teaspoons of the into a small cup or bowl.

Step 2 – Collect sachet(s) ____________________

Upon first opening, open the silver aluminium bag by cutting at the top using scissors. The aluminium bag includes 60 silver-coloured sachets (medicine) and one desiccant with the imprint “DO NOT EAT” including pictogram and “SILICA GEL”.


Collect the required number of sachets with Pradaxa coated granules according to the prescribed dose. Put the unused sachets back into the aluminium bag.

Step 3 – Open sachet(s)

Take the sachet containing the Pradaxa coated granules.
Tap the sachet on the table to ensure that the contents settle to the bottom.
Keep the sachet in an upright position.
Open the sachet by cutting at the top using scissors.

Step 4 – Pour sachet(s) content

Empty the entire content of the sachet into the small cup or bowl containing the soft food.
Repeat Steps 3 and 4 if more than one sachet is needed.

Step 5 – Stir soft food to mix coated granules

Stir soft food with the feeding spoon to thoroughly mix the coated granules with the soft food.
Administer the soft food with the coated granules to the patient immediately using the feeding spoon.
Assure that all soft food is eaten.

B) Administration of Pradaxa coated granules with apple juice

Step 1 – Have a cup of apple juice ready before the next step

Step 2 – Collect sachet(s)

Upon first opening, open the silver aluminium bag by cutting at the top using scissors. The aluminium bag includes 60 silver-coloured sachets (medicine) and one desiccant with the imprint “DO NOT EAT” including pictogram and “SILICA GEL”.
Do not open or consume the desiccant.

Collect the required number of sachets with Pradaxa coated granules according to the prescribed dose.
Put the unused sachets back into the aluminium bag.

3 – Open sachet(s)

Take the sachet containing the Pradaxa coated granules.
Tap the sachet on the table to ensure that the contents settle to the bottom.
Keep the sachet in an upright position.
Open the sachet by cutting at the top using scissors.

Step 4 – Administer Pradaxa coated granules with apple juice

Administer all of the coated granules directly from the sachet or using a feeding spoon into the child’s mouth and offer the child as much apple juice as needed to swallow the coated granules.
Inspect child’s mouth to ensure that all coated granules are swallowed.
Optional: If the Pradaxa coated granules are mixed in the apple juice cup, start with a small amount of apple juice (that your child is likely to drink completely) and ensure that all coated granules are taken. If coated granules are sticking to the cup, add another small amount of apple juice and again apply to your child. Repeat until no remaining coated granules are sticking to the cup.

Package leaflet: Information for the patient

Pradaxa 6.25 mg/mL powder and solvent for oral solution dabigatran etexilate

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your child’s doctor or pharmacist.
– This medicine has been prescribed for your child only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as your child’s.

– If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pradaxa is and what it is used for
2. What you need to know before your child takes Pradaxa
3. How to take Pradaxa
4. Possible side effects
5. How to store Pradaxa
6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

Pradaxa is used in children to treat blood clots and to prevent blood clots from reoccurring.

Pradaxa powder and solvent for oral solution should not be used in children aged 1 year or older.

2. What you need to know before your child takes Pradaxa

Do not use Pradaxa

– if your child is allergic to dabigatran etexilate or any of the other ingredients of this medicine

(listed in section 6).

– if your child has severely reduced kidney function.
– if your child is currently bleeding.
– if your child has a disease in an organ of the body that increases the risk of serious bleeding

(e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).

– if your child has an increased tendency to bleed. This may be inborn, of unknown cause or due

to other medicines.

– if your child is given medicines to prevent blood clotting (e.g.warfarin, rivaroxaban, apixaban or

heparin), except when changing anticoagulant treatment or while having a venous or arterial line and your child gets heparin through this line to keep it open.

– if your child has a severely reduced liver function or liver disease which could possibly cause

death.

– if your child is given oral ketoconazole or itraconazole, medicines to treat fungal infections.
– if your child is given oral cyclosporine, a medicine to prevent organ rejection after

transplantation.

– if your child is given dronedarone, a medicine used to treat abnormal heart beat.
– if your child is given a combination product of glecaprevir and pibrentasvir, an antiviral

medicine used to treat hepatitis C

– if your child has received an artificial heart valve which requires permanent blood thinning.

Warnings and precautions

Tell your child’s doctor if your child has or has had any medical conditions or illnesses, in particular any of those included in the following list:

– if your child has an increased bleeding risk, such as:

■ if your child has been recently bleeding.
■ if your child has had a surgical tissue removal (biopsy) in the past month.
■ if your child has had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment).
■ if your child is suffering from an inflammation of the gullet or stomach.
■ if your child has problems with reflux of gastric juice into the gullet.
■ if your child is receiving medicines which could increase the risk of bleeding. See ‚Other medicines and Pradaxa‘ below.
■ if your child is given anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
■ if your child is suffering from an infection of the heart (bacterial endocarditis).
■ if you know your child has decreased kidney function, or your child is suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) / foaming urine).
■ if your child has an infection around or within the brain.

– if your child has had a heart attack or if your child has been diagnosed with conditions that increase the risk to develop a heart attack.
– if your child has a liver disease that is associated with changes in the blood tests. The use of this medicine is not recommended in this case.

Take special care with Pradaxa

– if your child needs to have an operation:

– if an operation involves a catheter or injection into your child’s spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

■ it is very important to give Pradaxa before and after the operation exactly at the times you have been told by your child’s doctor.
■ tell your child’s doctor immediately if your child gets numbness or weakness of the legs or problems with his/her bowel or bladder after the end of anaesthesia, because urgent care is necessary.

– if your child falls or injures himself/herself during treatment, especially if your child hits his/her

head. Please seek urgent medical attention. Your child may need to be checked by a doctor, as your child may be at increased risk of bleeding.

– if you know that your child has a disease called antiphospholipid syndrome (a disorder of the

immune system that causes an increased risk of blood clots), tell your child’s doctor who will decide if the treatment may need to be changed.

Other medicines and Pradaxa

– Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
– Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin
– Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil).
– Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
– A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat

hepatitis C)

– Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
– St. John's wort, a herbal medicine for depression
– Antidepressant medicines called selective serotonin re-uptake inhibitors or serotoninnorepinephrine re-uptake inhibitors
– Rifampicin or clarithromycin (two antibiotics)
– Anti-viral medicines for AIDS (e.g. ritonavir)
– Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

This medicine is intended to be used in children below the age of 12 months. Information regarding pregnancy and breast-feeding will not be relevant in the context of your child’s treatment.

Driving and using machines

This medicine is intended to be used in children below the age of 12 months. Information regarding driving and using machines will not be relevant in the context of your child’s treatment.

3. How to take Pradaxa

Pradaxa powder and solvent for oral solution should only be used in children below 1 year. There are other age appropriate dose forms for the treatment of children and adolescents aged 1 year or older.

Always give this medicine exactly as your child’s doctor has told you. Check with your child’s doctor if you are not sure.

Pradaxa should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible.

Single Pradaxa dose to be given twice daily in millilitres (mL) by weight in kilograms (kg) and age in months of the patient:

Age in months

1 to

2 to <3

3 to

4 to

5 to

6 to

7 to

8 to

9 to <10

10 to <11

11 to

<12

13 to <16

12 mL

11 to <13

10 mL

11 mL

9 to <11

7 mL

8 mL

9 mL

7 to <9

5 mL

6 mL

7 mL

8 mL

5 to <7

3 mL

4 mL

5 mL

6 mL

7 mL

4 to <5

2 mL

3 mL

4 mL

5 mL

3 to <4

2 mL

3 mL

2.5 to <3

2 mL

3 mL

Means that no dosing recommendation can be provided.
oral solution [mL]	2	3	4	5	6	7	8	9	10	11	12
contains dabigatran etexilate [mg]	12.50	18.75	25.00	31.25	37.50	43.75	50.00	56.25	62.50	68.75	75.00

Instructions for preparing and giving Pradaxa oral solution

Pradaxa oral solution is prepared from Pradaxa powder, a sweetener (sucralose) and a solvent. It is administered with a dosing pipette into your child’s mouth. Pradaxa oral solution should not be mixed with milk, other beverages or food.

Detailed instructions for the preparation of the oral solution and the administration with the dosing pipette are provided in’Instructions for use’ at the end of the package leaflet.

The instructions for use contain all steps necessary for the correct preparation of this medicine and its administration to the patient. This medicine should be prepared by a doctor, nurse or pharmacist. Lay caregivers can prepare the oral solution if the healthcare professional determines that it is appropriate. In this case all steps of the instructions for use should be followed.

In case your doctor, nurse or pharmacist has provided you the prepared oral solution, please follow steps 11–22 of the instructions for use.

Change of anticoagulant treatment

Without specific guidance from your child’s doctor do not change your child’s anticoagulant treatment.

If you give more Pradaxa than you should

Taking too much of this medicine increases the risk of bleeding. Contact your child’s doctor immediately if you have given too much of it. Specific treatment options are available.

If you forget to give your child Pradaxa

A forgotten dose can still be given up to 6 hours prior to the next due dose.

A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose.

Do not give a double dose to make up for a forgotten dose.

If a dose has only been taken partially, do not attempt to administer a second dose at that time-point. Give the next dose as scheduled approximately 12 hours later.

If you stop giving Pradaxa

If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your child’s doctor immediately, if your child experiences a serious allergic reaction which causes difficulty in breathing or dizziness.

Possible side effects are listed below, grouped by how likely they are to happen.

Common (may affect up to 1 in 10 people):

– A fall in the number of red cells in the blood
– A fall in the number of platelets in the blood
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Haematoma formation
– Nosebleed
– Reflux of gastric juice into the gullet
– Vomiting
– Feeling sick
– Frequent loose or liquid bowel movements
– Indigestion
– Hair loss
– Liver enzymes increased

Uncommon (may affect up to 1 in 100 people):

– Decrease in the number of white blood cells (which help to fight infections)
– Bleeding may happen into the stomach or bowel, from the brain, from the rectum, from

penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin

– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– A decrease in the proportion of blood cells
– Itching
– Coughing of blood or blood stained sputum
– Belly ache or stomach ache
– Inflammation of the gullet and stomach
– Allergic reaction
– Difficulty in swallowing
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

– Lack of white blood cells (which help to fight infections)
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Difficulty in breathing or wheezing
– Bleeding
– Bleeding may happen into a joint or from an injury, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein
– Bleeding may happen from piles
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Unusual laboratory test results on liver function

Reporting of side effects

5. How to store Pradaxa

Keep this medicine out of the sight and reach of children.

This medicine is prepared from three components which may have different expiry dates. Do not prepare and use this medicine after the shortest expiry date which is stated on the outer carton after “EXP”. Note that individual components may have later expiry dates. The expiry date refers to the last day of that month.

Store so that the bottle inside each individual preparation pack is upright.

Once the aluminium bag containing the sachets with the Pradaxa powder for oral solution and the desiccant is opened, the medicine must be used within 4 months. The opened sachet cannot be stored and must be used immediately after opening.

Once prepared, the oral solution in the bottle can be stored for up to 18 hours at 2–8°C (refrigerator) or, if needed, for up to 2 hours at room temperature (20–25°C). The bottles must be stored in an upright position.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pradaxa contains

– The active substance is dabigatran. Each mL of reconstituted oral solution contains 6.25 mg of dabigatran etexilate (as mesilate).
– The other ingredients of the Pradaxa powder for oral solution are mannitol and hydroxypropylcellulose.
– The solvent for Pradaxa oral solution contains tartaric acid, hydrochloric acid (for pH-adjustment) and purified water.
– The sucralose sachets contain sucralose.

What Pradaxa looks like and contents of the pack

Pradaxa powder and solvent for oral solution is supplied as several components for reconstitution in a kit that contains:

1 carton box containing the Pradaxa powder for oral solution.
30 aluminium sachets are packaged in one aluminium bag that also contains a desiccant (labelled with “DO NOT EAT” including pictogram and “SILICA GEL”). Each sachet contains 180.4 mg powder for oral solution. Pradaxa powder for oral solution is a yellowish-white powder.

30 carton boxes which are referred to as individual preparation packs.

Each pack contains one white aluminium sachet with 70 mg sucralose powder (white to almost white powder), one amber glass bottle with a screw-cap containing 28 mL solvent (clear, colourless solution) to prepare the oral solution, two dosing pipettes (12 mL) and one adapter for the bottle.

The co-packaged dosing pipettes and the adapter are medical devices.

On the 12 mL dosing pipette, a scale from 0 to 12 mL with 0.25 mL graduation is printed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Catalent Germany Schorndorf GmbH

Steinbeisstr. 1 und 2

73614 Schorndorf

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel: +370 5 2595942

Efc^rapufl

EbopuHrep HHrenxaňM PUB R-ioX u Ko. Kr -K.TOH Ebnrapua

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tel/Tel: +32 2 773 33 11

Ten: +359 2 958 79 98

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarorszag

Boehringer Ingelheim RCV GmbH & Co KG

Magyarorszagi Fioktelepe

Tel: +36 1 299 8900

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Tel: +372 612 8000

EXXáSa

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105–7870

España

Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena-Sucursala Bucuresti

Tel: +40 21 302 2800

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Kûnpoç

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiâle

Tel: +371 67 240 011

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

United Kingdom (Northern Ireland)

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

Instructions for use

Do not administer Pradaxa coated granules

via syringes or feeding tubes
with other than the soft foods or apple juice as indicated below

Administer Pradaxa coated granules either with soft foods or apple juice. The instructions are provided below under A) for soft foods and B) for apple juice.

The prepared medicine should be given before meals in order to ensure that the patient takes the full dose.

In case of an incomplete intake of the prepared medicine, do not apply a second dose, wait until the next dosing time-point.

A) Administration of Pradaxa coated granules with soft foods

The food should be at room temperature before mixing with the coated granules. The medicine can be administered with one of the following soft foods:

Mashed carrots
Apple sauce (for administration with apple juice see B))
Mashed banana

Do not use soft food containing milk products.

Step 1 – Prepare cup or bowl

Transfer two teaspoons of the into a small cup or bowl.

Step 2 – Collect sachet(s) ____________________

Upon first opening, open the silver aluminium bag by cutting at the top using scissors. The aluminium bag includes 60 silver-coloured sachets (medicine) and one desiccant with the imprint “DO NOT EAT” including pictogram and “SILICA GEL”.


Collect the required number of sachets with Pradaxa coated granules according to the prescribed dose. Put the unused sachets back into the aluminium bag.

Step 3 – Open sachet(s)

Take the sachet containing the Pradaxa coated granules.
Tap the sachet on the table to ensure that the contents settle to the bottom.
Keep the sachet in an upright position.
Open the sachet by cutting at the top using scissors.

Step 4 – Pour sachet(s) content

Empty the entire content of the sachet into the small cup or bowl containing the soft food.
Repeat Steps 3 and 4 if more than one sachet is needed.

Step 5 – Stir soft food to mix coated granules

Stir soft food with the feeding spoon to thoroughly mix the coated granules with the soft food.
Administer the soft food with the coated granules to the patient immediately using the feeding spoon.
Assure that all soft food is eaten.

B) Administration of Pradaxa coated granules with apple juice

Step 1 – Have a cup of apple juice ready before the next step

Step 2 – Collect sachet(s)

Upon first opening, open the silver aluminium bag by cutting at the top using scissors. The aluminium bag includes 60 silver-coloured sachets (medicine) and one desiccant with the imprint “DO NOT EAT” including pictogram and “SILICA GEL”.
Do not open or consume the desiccant.

Collect the required number of sachets with Pradaxa coated granules according to the prescribed dose.
Put the unused sachets back into the aluminium bag.

3 – Open sachet(s)

Take the sachet containing the Pradaxa coated granules.
Tap the sachet on the table to ensure that the contents settle to the bottom.
Keep the sachet in an upright position.
Open the sachet by cutting at the top using scissors.

Step 4 – Administer Pradaxa coated granules with apple juice

Administer all of the coated granules directly from the sachet or using a feeding spoon into the child’s mouth and offer the child as much apple juice as needed to swallow the coated granules.
Inspect child’s mouth to ensure that all coated granules are swallowed.
Optional: If the Pradaxa coated granules are mixed in the apple juice cup, start with a small amount of apple juice (that your child is likely to drink completely) and ensure that all coated granules are taken. If coated granules are sticking to the cup, add another small amount of apple juice and again apply to your child. Repeat until no remaining coated granules are sticking to the cup.

Package leaflet: Information for the patient

Pradaxa 6.25 mg/mL powder and solvent for oral solution dabigatran etexilate

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your child’s doctor or pharmacist.
– This medicine has been prescribed for your child only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as your child’s.

– If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pradaxa is and what it is used for
2. What you need to know before your child takes Pradaxa
3. How to take Pradaxa
4. Possible side effects
5. How to store Pradaxa
6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

Pradaxa is used in children to treat blood clots and to prevent blood clots from reoccurring.

Pradaxa powder and solvent for oral solution should not be used in children aged 1 year or older.

2. What you need to know before your child takes Pradaxa

Do not use Pradaxa

– if your child is allergic to dabigatran etexilate or any of the other ingredients of this medicine

(listed in section 6).

– if your child has severely reduced kidney function.
– if your child is currently bleeding.
– if your child has a disease in an organ of the body that increases the risk of serious bleeding

(e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes).

– if your child has an increased tendency to bleed. This may be inborn, of unknown cause or due

to other medicines.

– if your child is given medicines to prevent blood clotting (e.g.warfarin, rivaroxaban, apixaban or

heparin), except when changing anticoagulant treatment or while having a venous or arterial line and your child gets heparin through this line to keep it open.

– if your child has a severely reduced liver function or liver disease which could possibly cause

death.

– if your child is given oral ketoconazole or itraconazole, medicines to treat fungal infections.
– if your child is given oral cyclosporine, a medicine to prevent organ rejection after

transplantation.

– if your child is given dronedarone, a medicine used to treat abnormal heart beat.
– if your child is given a combination product of glecaprevir and pibrentasvir, an antiviral

medicine used to treat hepatitis C

– if your child has received an artificial heart valve which requires permanent blood thinning.

Warnings and precautions

Tell your child’s doctor if your child has or has had any medical conditions or illnesses, in particular any of those included in the following list:

– if your child has an increased bleeding risk, such as:

■ if your child has been recently bleeding.
■ if your child has had a surgical tissue removal (biopsy) in the past month.
■ if your child has had a serious injury (e.g. a bone fracture, head injury or any injury requiring surgical treatment).
■ if your child is suffering from an inflammation of the gullet or stomach.
■ if your child has problems with reflux of gastric juice into the gullet.
■ if your child is receiving medicines which could increase the risk of bleeding. See ‚Other medicines and Pradaxa‘ below.
■ if your child is given anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam.
■ if your child is suffering from an infection of the heart (bacterial endocarditis).
■ if you know your child has decreased kidney function, or your child is suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) / foaming urine).
■ if your child has an infection around or within the brain.

– if your child has had a heart attack or if your child has been diagnosed with conditions that increase the risk to develop a heart attack.
– if your child has a liver disease that is associated with changes in the blood tests. The use of this medicine is not recommended in this case.

Take special care with Pradaxa

– if your child needs to have an operation:

– if an operation involves a catheter or injection into your child’s spinal column (e.g. for epidural or spinal anaesthesia or pain reduction):

■ it is very important to give Pradaxa before and after the operation exactly at the times you have been told by your child’s doctor.
■ tell your child’s doctor immediately if your child gets numbness or weakness of the legs or problems with his/her bowel or bladder after the end of anaesthesia, because urgent care is necessary.

– if your child falls or injures himself/herself during treatment, especially if your child hits his/her

head. Please seek urgent medical attention. Your child may need to be checked by a doctor, as your child may be at increased risk of bleeding.

– if you know that your child has a disease called antiphospholipid syndrome (a disorder of the

immune system that causes an increased risk of blood clots), tell your child’s doctor who will decide if the treatment may need to be changed.

Other medicines and Pradaxa

– Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
– Medicines to treat fungal infections (e.g. ketoconazole, itraconazole), unless they are only applied to the skin
– Medicines to treat abnormal heart beats (e.g. amiodarone, dronedarone, quinidine, verapamil).
– Medicines to prevent organ rejection after transplantation (e.g. tacrolimus, cyclosporine)
– A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat

hepatitis C)

– Anti-inflammatory and pain reliever medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
– St. John's wort, a herbal medicine for depression
– Antidepressant medicines called selective serotonin re-uptake inhibitors or serotoninnorepinephrine re-uptake inhibitors
– Rifampicin or clarithromycin (two antibiotics)
– Anti-viral medicines for AIDS (e.g. ritonavir)
– Certain medicines for treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breast-feeding

This medicine is intended to be used in children below the age of 12 months. Information regarding pregnancy and breast-feeding will not be relevant in the context of your child’s treatment.

Driving and using machines

This medicine is intended to be used in children below the age of 12 months. Information regarding driving and using machines will not be relevant in the context of your child’s treatment.

3. How to take Pradaxa

Always give this medicine exactly as your child’s doctor has told you. Check with your child’s doctor if you are not sure.

Pradaxa should be taken twice daily, one dose in the morning and one dose in the evening, at approximately the same time every day. The dosing interval should be as close to 12 hours as possible.

Single Pradaxa dose to be given twice daily in millilitres (mL) by weight in kilograms (kg) and age in months of the patient:

Age in months

1 to

2 to <3

3 to

4 to

5 to

6 to

7 to

8 to

9 to <10

10 to <11

11 to

<12

13 to <16

12 mL

11 to <13

10 mL

11 mL

9 to <11

7 mL

8 mL

9 mL

7 to <9

5 mL

6 mL

7 mL

8 mL

5 to <7

3 mL

4 mL

5 mL

6 mL

7 mL

4 to <5

2 mL

3 mL

4 mL

5 mL

3 to <4

2 mL

3 mL

2.5 to <3

2 mL

3 mL

Means that no dosing recommendation can be provided.
oral solution [mL]	2	3	4	5	6	7	8	9	10	11	12
contains dabigatran etexilate [mg]	12.50	18.75	25.00	31.25	37.50	43.75	50.00	56.25	62.50	68.75	75.00

Instructions for preparing and giving Pradaxa oral solution

Detailed instructions for the preparation of the oral solution and the administration with the dosing pipette are provided in’Instructions for use’ at the end of the package leaflet.

In case your doctor, nurse or pharmacist has provided you the prepared oral solution, please follow steps 11–22 of the instructions for use.

Change of anticoagulant treatment

Without specific guidance from your child’s doctor do not change your child’s anticoagulant treatment.

If you give more Pradaxa than you should

Taking too much of this medicine increases the risk of bleeding. Contact your child’s doctor immediately if you have given too much of it. Specific treatment options are available.

If you forget to give your child Pradaxa

A forgotten dose can still be given up to 6 hours prior to the next due dose.

A missed dose should be omitted if the remaining time is below 6 hours prior to the next due dose.

Do not give a double dose to make up for a forgotten dose.

If a dose has only been taken partially, do not attempt to administer a second dose at that time-point. Give the next dose as scheduled approximately 12 hours later.

If you stop giving Pradaxa

If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your child’s doctor immediately, if your child experiences a serious allergic reaction which causes difficulty in breathing or dizziness.

Possible side effects are listed below, grouped by how likely they are to happen.

Common (may affect up to 1 in 10 people):

– A fall in the number of red cells in the blood
– A fall in the number of platelets in the blood
– Skin rash notable for dark red, raised, itchy bumps caused by an allergic reaction
– Sudden change of the skin which affects its colour and appearance
– Haematoma formation
– Nosebleed
– Reflux of gastric juice into the gullet
– Vomiting
– Feeling sick
– Frequent loose or liquid bowel movements
– Indigestion
– Hair loss
– Liver enzymes increased

Uncommon (may affect up to 1 in 100 people):

– Decrease in the number of white blood cells (which help to fight infections)
– Bleeding may happen into the stomach or bowel, from the brain, from the rectum, from

penis/vagina or urinary tract (incl. blood in the urine that stains the urine pink or red), or under the skin

– A fall in the amount of haemoglobin in the blood (the substance in the red blood cells)
– A decrease in the proportion of blood cells
– Itching
– Coughing of blood or blood stained sputum
– Belly ache or stomach ache
– Inflammation of the gullet and stomach
– Allergic reaction
– Difficulty in swallowing
– Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Not known (frequency cannot be estimated from the available data):

– Lack of white blood cells (which help to fight infections)
– Serious allergic reaction which causes difficulty in breathing or dizziness
– Serious allergic reaction which causes swelling of the face or throat
– Difficulty in breathing or wheezing
– Bleeding
– Bleeding may happen into a joint or from an injury, from a surgical incision, or from the site of entry of an injection or from the site of entry of a catheter into a vein
– Bleeding may happen from piles
– Ulcer in the stomach or bowel (incl. ulcer in the gullet)
– Unusual laboratory test results on liver function

Reporting of side effects

5. How to store Pradaxa

Keep this medicine out of the sight and reach of children.

Store so that the bottle inside each individual preparation pack is upright.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Pradaxa contains

– The active substance is dabigatran. Each mL of reconstituted oral solution contains 6.25 mg of dabigatran etexilate (as mesilate).
– The other ingredients of the Pradaxa powder for oral solution are mannitol and hydroxypropylcellulose.
– The solvent for Pradaxa oral solution contains tartaric acid, hydrochloric acid (for pH-adjustment) and purified water.
– The sucralose sachets contain sucralose.

What Pradaxa looks like and contents of the pack

Pradaxa powder and solvent for oral solution is supplied as several components for reconstitution in a kit that contains:

1 carton box containing the Pradaxa powder for oral solution.
30 aluminium sachets are packaged in one aluminium bag that also contains a desiccant (labelled with “DO NOT EAT” including pictogram and “SILICA GEL”). Each sachet contains 180.4 mg powder for oral solution. Pradaxa powder for oral solution is a yellowish-white powder.

30 carton boxes which are referred to as individual preparation packs.

The co-packaged dosing pipettes and the adapter are medical devices.

On the 12 mL dosing pipette, a scale from 0 to 12 mL with 0.25 mL graduation is printed.

Marketing Authorisation Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Catalent Germany Schorndorf GmbH

Steinbeisstr. 1 und 2

73614 Schorndorf

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

SCS Boehringer Ingelheim Comm.V

Tél/Tel: +32 2 773 33 11

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Lietuvos filialas

Tel: +370 5 2595942

Efc^rapufl

EbopuHrep HHrenxaňM PUB R-ioX u Ko. Kr -K.TOH Ebnrapua

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm.V

Tel/Tel: +32 2 773 33 11

Ten: +359 2 958 79 98

Česká republika

Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111

Magyarorszag

Boehringer Ingelheim RCV GmbH & Co KG

Magyarorszagi Fioktelepe

Tel: +36 1 299 8900

Danmark

Boehringer Ingelheim Danmark A/S

Tlf: +45 39 15 88 88

Malta

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Deutschland

Boehringer Ingelheim Pharma GmbH & Co. KG

Tel: +49 (0) 800 77 90 900

Nederland

Boehringer Ingelheim b.v.

Tel: +31 (0) 800 22 55 889

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Eesti filiaal

Norge

Boehringer Ingelheim Norway KS

Tlf: +47 66 76 13 00

Tel: +372 612 8000

EXXáSa

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Österreich

Boehringer Ingelheim RCV GmbH & Co KG

Tel: +43 1 80 105–7870

España

Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00

Polska

Boehringer Ingelheim Sp.zo.o.

Tel: +48 22 699 0 699

France

Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33

Portugal

Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00

Hrvatska

Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600

România

Boehringer Ingelheim RCV GmbH & Co KG

Viena-Sucursala Bucuresti

Tel: +40 21 302 2800

Ireland

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Podružnica Ljubljana

Tel: +386 1 586 40 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka

Tel: +421 2 5810 1211

Italia

Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1

Suomi/Finland

Boehringer Ingelheim Finland Ky

Puh/Tel: +358 10 3102 800

Kûnpoç

Boehringer Ingelheim Ellas A.E.

Tql: +30 2 10 89 06 300

Latvija

Boehringer Ingelheim RCV GmbH & Co KG

Latvijas filiâle

Tel: +371 67 240 011

Sverige

Boehringer Ingelheim AB

Tel: +46 8 721 21 00

United Kingdom (Northern Ireland)

Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

Instructions for use

Pradaxa 6.25 mg/mL powder and solvent for oral solution

Read instructions before use

You have received an oral solution kit containing 30 preparation packs and one aluminum bag containing 30 silver coloured sachets. One silver coloured sachet contains yellowish-white powder (medicine) for preparing an oral solution. The aluminum bag also contains a desiccant (labelled with “DO NOT EAT” including pictogram and “SILICA GEL”) to keep the medicine dry.

The instructions for use contain all steps necessary for the correct preparation of the oral solution and administration to the patient. The oral solution should be prepared by a doctor, nurse or pharmacist. Lay caregivers can prepare the oral solution if the treating physician determines that it is appropriate. All steps of the instructions for use should be followed. In case your doctor, nurse or pharmacist has provided you the prepared oral solution, please follow steps 11–22.

You can preserve the prepared oral solution for 2 hours at room temperature or 18 hours in a refrigerator. Give two doses per day with an interval as close to 12 hours as possible.

Supplies for preparing medicine

You will need the following supplies to prepare the medicine, included in each individual preparation pack:

A. Bottle containing 28 mL solvent.
B. Pipette adapter.
C. White (sucralose) sachet containing sweetener.
D. 2 Dosing pipettes (12 mL).

Discard dosing pipette after use (single use only).

You will need the following other supplies, not included in each individual preparation pack:

E. Silver (dabigatran etexilate) sachet containing powder (medicine), included in the aluminum bag.
F. Pair of scissors (not supplied).
G. Pen (not supplied).

x 30

x 1

Do not use desiccant (Silica Gel) to prepare oral solution.

Warnings and Cautions

Read all warnings and cautions before preparing the medicine.

Warnings

Store prepared oral solution in the bottle for up to 18 hours in a refrigerator at 2°C to 8°C. The oral solution may be stored for a maximum of2 hours at room temperature (20°C to 25°C).
Safely throw away any unused oral solution left in the bottle after 18 hours.
Do not prepare oral solution with liquid other than the solvent that comes in the kit.
Do not mix prepared oral solution with milk, other beverages, baby formula or any other kind

of food.

Do not use a measuring device other than the dosing pipettes that come in your kit to measure and give a dose of this medicine.
Do not heat oral solution.

COu Cautions

To avoid a reduced dose of medicine, make sure to pour all contents of silver sachet (medicine) into solvent bottle.
Take care to adjust dosing pipette carefully to the prescribed dose. Check dose before administration.
The interval between dosing of this medicine should be as close to 12 hours as possible.
If a dose is missed for any reason, the forgotten dose may still be taken up to 6 hours prior to

the next scheduled dose.

If a missed dose cannot be taken up to 6 hours prior to the next scheduled dose, omit the missed dose and administer the next dose as scheduled.
Do not administer a double dose to make up for a missed individual dose or for an incomplete dose intake.
Do not use feeding tubes.

Prepare Oral Solution

1 Place one silver sachet (dabigatran etexilate) in an individual preparation pack

A. Place 1 silver sachet from the aluminum bag in each individual preparation pack.
B. The bag contains a desiccant (labelled with “DO NOT EAT” including pictogram and “SILICA GEL”) with silica gel to keep contents dry.

Do not use desiccant to prepare the oral solution.

C. Before each use, make sure each individual preparation pack contains: 1 bottle, 1 silver (dabigatran etexilate) sachet, 1 white (sucralose) sachet, 1 adapter and 2 dosing pipettes (12 mL).

If you are going to travel make sure you have completed Step 1 before travelling for all doses to be given during travel.

To avoid preparing the oral solution without medicine, it is recommended that you complete all individual preparation packs with the silver sachet at the point in time when you are preparing the first dose of a new oral solution kit.

2 Prepare bottle

D. Take the bottle with solvent out of the individual preparation pack.
E. Open bottle in an upright position by pressing down on the child resistant cap and simultaneously turning the cap counter-clockwise.
F. Leave the open bottle on the table.

3 Open silver (dabigatran etexilate) sachet

A. Take the silver (dabigatran etexilate) sachet containing powder (medicine).
B. Tap the silver sachet on the table to

ensure the silver sachet contents settle to

the bottom.

C. Keep the silver sachet in upright position.
D. Open the silver sachet by cutting at the top using scissors.

4 Pour silver sachet contents

A. Hold and squeeze the silver sachet to ensure a circular opening.
B. Carefully pour all the content of the silver sachet (medicine) into the bottle, tapping the sachet until it is empty.

To avoid a reduced dose of medicine, make sure to pour all contents of sachet into solvent bottle.

5 Open white (sucralose) sachet

A. Take the white (sucralose) sachet containing sweetener.
B. Tap the white sachet on the table to ensure the white sachet contents settle to the bottom.
C. Keep the white sachet in upright position.
D. Open the white sachet by cutting at the top using scissors.

6 Pour white sachet contents

A. Hold and squeeze the white sachet to ensure a circular opening.
B. Carefully pour all the content of the white sachet (sweetener) into the bottle, tapping the sachet until it is empty.

7 Insert adapter

A. With the open bottle on the table, hold the bottle with one hand and press the pipette adapter into the bottle opening with the other hand.

Make sure the adapter is completely inserted in bottle neck until the adapter cannot be pushed any further.

8 Close bottle and write date and time on label

A. Tightly close the bottle with the cap (turn the cap clockwise).
B. Assure that the cap is securely attached to avoid medicine from spilling.
C. Write the date and time on the bottle label next to “Date and Time of preparation:”.

9 Shake bottle to dissolve medicine

A. Shake the bottle vigorously for at least 2 minutes to dissolve the medicine powder in the solution. Use a stopwatch or clock to measure 2 minutes.

Shaking the bottle for less than 2 minutes could lead to undissolved powder in the bottle leading to a reduced dose of the medicine.

10 Wait for 1 minute

A. Wait for at least 1 minute after shaking bottle to let most of the bubbles disappear. Use a stopwatch or clock to measure 1 minute.
B. Check if all powder in the bottle is dissolved. If not, shake bottle until powder (medicine) in the solution is dissolved.

△ If you do not allow the bottle to sit for at least 1 minute, there may be air bubbles in the oral solution. You may not be able to measure and give the correct dose of the medicine.

Fill Dosing Pipette

11 Check prescribed dose

Your doctor should tell you the amount (dose) of Pradaxa oral solution to give to your child in millilitres (mL).

The dose of this medicine will change based on your child’s age and weight over time as your child grows. Ask your doctor or pharmacist if you are not sure.

12 Fill dosing pipette with air

Take the empty 12 mL dosing pipette and pull back on the plunger half way to fill the dosing pipette with 7 mL of air.

13 Attach dosing pipette and push air into the bottle

A. Attach the empty dosing pipette onto the adapter until it feels secure and cannot be pushed further.
B. Press in the plunger carefully and slowly, pushing the air into the bottle.

Push air into the bottle to avoid low-

pressure problems especially with large (> 6 mL) volumes.

14 Fill dosing pipette

A. Turn the dosing pipette together with the bottle upside down.
B. While holding the bottle together with the dosing pipette barrel with one hand, pull the plunger to the correct dosing volume with the other hand.
C. Stop when the upper edge of the plunger is at the mark corresponding to the correct dosing volume.

E hili illijiihill

15 Check dosing pipette for air

A. If there are air bubbles in the dosing pipette, tap on the barrel of the dosing pipette to move any air bubbles to the top.
B. Slowly press up on the plunger until all air bubbles have been removed.
C. Check that the dose is correct. If not, pull back on the plunger until you get the prescribed dose.

Leaving air bubbles in the solution in the dosing pipette leads to a reduced dose of the medicine.

16 Remove dosing pipette

A. Holding the dosing pipette by the barrel to avoid readjusting the dose by mistake, put the bottle back on the table.
B. Holding the dosing pipette by the barrel, pull the dosing pipette off of the adapter and bottle.
C. Make sure the dosing pipette is still filled with the correct dose.

Note: The plunger’s position might be different from the image.

C Administer Oral Solution

17 Position child

Position the child upright to give the oral solution.

18 Administer oral solution

You should administer the required dose to the child within 10 minutes of filling the dosing pipette.

Give two doses per day with an interval as close to 12 hours as possible.

A. Place the dosing pipette in the child’s mouth, so the tip is near the inner side of the cheek.
B. Press the plunger carefully and slowly to give the child sufficient time to swallow the solution.

Do not give the oral solution if it has been stored for more than 2 hours at room

temperature.

Discard the oral solution if it has been stred for more than 2 hours at room temperature.

Do not store the oral solution in dosing

pipette.

19 Close bottle and discard used dosing pipette

A. Leave the pipette adapter in the bottle.
B. Close the bottle tightly with the cap.

Note: Make sure that the pipette adapter is inserted completely so that you are able to close the bottle properly.

C. Discard the used dosing pipette.
D. If you will not be administering another dose from the same bottle, continue directly to Step 22 to discard the bottle.

D Store Or Discard Oral Solution

20 Store bottle in refrigerator until second dose

Place the closed bottle containing the medicine immediately in the refrigerator in an upright position.

Give two doses per day with an interval as close to 12 hours as possible. Use the oral solution within 18 hours and discard the bottle after 18 hours or after giving the second dose.

△ The interval between dosing of this

medicine should be as close to 12 hours as possible.

The bottle with the medicine can be

stored for up to 18 hours in the refrigerator. Discard bottle after 18 hours or after giving the second dose, even if there is oral solution still left in it.

21 Administer second dose

Follow these steps if the prepared medicine is used a second time about 12 hours later:

A. Remove medicine bottle from the refrigerator.
B. If the child does not like the cold medicine you can let the bottle of oral solution sit at room temperature to warm up. Once removed from the refridgerator, you must give the oral solution within 2 hours.

Do not use microwave, hot water or other heating devices.

C. Open the bottle.
D. Collect the second dosing pipette.

Each dosing pipette is a single use device.

E. Repeat Steps 11 through 19 to administer a second dose to the child.

22 Discard used items and bottle

A. Discard all empty used dosing pipettes and empty sachets.

△ Discard dosing pipette after use (single use only).

B. Once dosing is complete, or after the medicine is beyond use (2 hours at room temperature, or 18 hours in a refrigerator), discard the closed bottle.

Pradaxa® capsules dabigatran etexilate

This card should be with you / the caregiver at all times
Make sure to use the latest version

[xxxx 20×x]

[Boehringer Ingelheim logo]

Dear Patient / Caregiver of a paediatric patient,

Your / your child’s doctor has initiated treatment with Pradaxa®. In order to use Pradaxa® safely, please consider the important information in the package leaflet.

As this patient alert card contains important information about your / your child’s treatment, this card should be with you / your child at all times to inform healthcare professionals about your / your child’s intake of Pradaxa®.

[Pradaxa logo]

Pradaxa® Information for Patients / Caregivers of paediatric patients

About your / your child’s treatment

Pradaxa® thins the blood. It is used to treat existing blood clots or to prevent the formation of

dangerous blood clots.

Follow your / your child’s doctor’s instructions when taking Pradaxa®. Never skip a dose or stop the intake of Pradaxa® without talking to your / your child’s doctor.
Inform your / your child’s doctor about all medicines you / your child are / is currently taking.
Inform your / your child’s doctor about the intake of Pradaxa® before any surgery / invasive

procedure.

Pradaxa® capsules can be taken with or without food. The capsule should be swallowed whole

with a glass of water. The capsule must not be broken or chewed and the pellets must not be emptied from the capsule.

When to seek medical advice

Taking Pradaxa® may increase the risk of bleeding. Speak to your / your child’s doctor immediately if you / your child experience(s) signs and symptoms of bleeding such as: swelling, discomfort, unusual pain or headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding of gums, unusual long bleeding cuts, abnormal menstrual flow or vaginal bleeding, blood in the urine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or coffee ground like material.
In case of fall or injury, especially if the head is hit, urgently seek medical advice.
Do not stop intake of Pradaxa® without talking to your / your child’s doctor, if you / your child experience(s) heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.

Pradaxa® Information for Healthcare Professionals

Pradaxa® is an oral anticoagulant (direct thrombin inhibitor).
Pradaxa® may need to be stopped in advance of surgical or other invasive procedures.
In case of major bleeding events, Pradaxa® must be stopped immediately.
A specific reversal agent (idarucizumab) is available for adult patients. The efficacy and safety of the specific reversal agent idarucizumab have not been established in paediatric patients. For details and more advice to antagonise the anticoagulant effect of Pradaxa® please refer to the Summary of Product Characteristics of Pradaxa® and idarucizumab.

Pradaxa® is mainly eliminated by the kidneys; adequate diuresis must be maintained. Pradaxa® is dialyzable.

Please complete this section or ask your / your child’s doctor to do it.

Patient Information

Name of the patient

Date of birth

Indication for anticoagulation

Dose of Pradaxa®

PATIENT ALERT CARD

Pradaxa® coated granules dabigatran etexilate

This card should be with the caregiver or the patient at all times
Make sure to use the latest version

[xxxx 20×x] [Boehringer Ingelheim logo]

Dear Caregiver,

Your child’s doctor has initiated treatment with Pradaxa®. In order to use Pradaxa® safely, please consider the important information in the package leaflet.

As this patient alert card contains important information about your child’s treatment, this card should be with you or your child at all times to inform healthcare professionals about your child’s intake of Pradaxa®.

[Pradaxa logo]

Pradaxa® Information for Caregivers

About your child’s treatment

Pradaxa® thins the blood. It is used to treat existing blood clots or to prevent the formation of

dangerous blood clots.

Follow your child’s doctor’s instructions for Pradaxa® use. Always administer the prescribed dose, never skip a dose or stop the use of Pradaxa® without talking to your child’s doctor.
Inform your child’s doctor about all medicines your child is currently taking.
Inform your child’s doctor about your child’s intake of Pradaxa® before any surgery/invasive procedure.
Pradaxa® coated granules should be administered with soft food or apple juice according to

the instructions for use in the package leaflet. Do not use soft food containing milk products. Do not administer Pradaxa® coated granules via syringes or feeding tubes.

When to seek medical advice

Taking Pradaxa® may increase the risk of bleeding. Speak to your child’s doctor immediately

if your child experiences any signs and symptoms of bleeding such as: swelling, discomfort, unusual pain or headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding of gums, unusually long bleeding cuts, abnormal menstrual flow or vaginal bleeding, blood in the urine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or coffee ground like material.

If your child falls or injures herself/himself, especially if she/he hits her/his head, urgently

seek medical advice.

Do not stop giving Pradaxa® without talking to your child’s doctor, if your child experiences heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.

Pradaxa® Information for Healthcare Professionals

Pradaxa® is an oral anticoagulant (direct thrombin inhibitor).
Pradaxa® may need to be stopped in advance of surgical or other invasive procedures.
In case of major bleeding events, Pradaxa® must be stopped immediately.
Pradaxa® is mainly eliminated by the kidneys; adequate diuresis must be maintained. Pradaxa®

is dialyzable. See Summary of Product Characteristics.

Please complete this section or ask your child’s doctor to do it.

Patient Information

Name of the patient

Date of birth

Indication for anticoagulation

Dose of Pradaxa®

PATIENT ALERT CARD

Pradaxa® powder and solvent for oral solution dabigatran etexilate

This card should be with the caregiver at all times
Make sure to use the latest version

[xxxx 20×x] [Boehringer Ingelheim logo]

Dear Caregiver,

Your child’s doctor has initiated treatment with Pradaxa®. In order to use Pradaxa® safely, please consider the important information in the package leaflet and the instructions for use.

As this patient alert card contains important information about your child’s treatment, please carry this card with you at all times to inform healthcare professionals about your child’s intake of Pradaxa®.

[Pradaxa logo]

Pradaxa® Information for Caregivers

About your child’s treatment

Pradaxa® thins the blood. It is used to treat existing blood clots or to prevent the formation of

dangerous blood clots.

Follow your child’s doctor’s instructions for Pradaxa® use. Always administer the prescribed dose, never skip a dose or stop the use of Pradaxa® without talking to your child’s doctor.
Inform your child’s doctor about all medicines your child is currently taking.
Inform your child’s doctor about your child’s intake of Pradaxa® before any surgery/invasive procedure.
Pradaxa® oral solution should be prepared by your child’s doctor, nurse or pharmacist. You

may prepare Pradaxa® oral solution if your child’s doctor thinks that this is appropriate. For administration carefully follow the instructions for use. Do not administer Pradaxa® oral solution via feeding tubes.

When to seek medical advice

Taking Pradaxa® may increase the risk of bleeding. Speak to your child’s doctor immediately

if your child experiences any signs and symptoms of bleeding such as: swelling, discomfort, unusual pain or headache, dizziness, paleness, weakness, unusual bruising, nosebleeds, bleeding of gums, unusually long bleeding cuts, vaginal bleeding, blood in the urine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or coffee ground like material.

If your child falls or injures herself/himself, especially if she/he hits her/his head, urgently

seek medical advice.

Do not stop giving Pradaxa® without talking to your child’s doctor, if your child experiences heartburn, nausea, vomiting, stomach discomfort, bloating or upper abdominal pain.

Pradaxa® Information for Healthcare Professionals

Pradaxa® is an oral anticoagulant (direct thrombin inhibitor).
Pradaxa® may need to be stopped in advance of surgical or other invasive procedures.
In case of major bleeding events, Pradaxa® must be stopped immediately.
Pradaxa® is mainly eliminated by the kidneys; adequate diuresis must be maintained. Pradaxa®

Pradaxa - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Pradaxa

1. What Pradaxa is and what it is used for

2. What you need to know before you take Pradaxa

3. How to take Pradaxa

4. Possible side effects

5. How to store Pradaxa

6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

2. What you need to know before you take Pradaxa

3. How to take Pradaxa

4. Possible side effects

5. How to store Pradaxa

6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

2. What you need to know before you take Pradaxa

3. How to take Pradaxa

4. Possible side effects

5. How to store Pradaxa

6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

2. What you need to know before your child takes Pradaxa

3. How to take Pradaxa

4. Possible side effects

5. How to store Pradaxa

6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

2. What you need to know before your child takes Pradaxa

3. How to take Pradaxa

4. Possible side effects

5. How to store Pradaxa

6. Contents of the pack and other information

1. What Pradaxa is and what it is used for

2. What you need to know before your child takes Pradaxa

3. How to take Pradaxa

Detailed instructions for the preparation of the oral solution and the administration with the dosing pipette are provided in’Instructions for use’ at the end of the package leaflet.

4. Possible side effects

5. How to store Pradaxa

6. Contents of the pack and other information

What Pradaxa looks like and contents of the pack

Instructions for use