PRADAXA 110 MG COATED GRANULES - patient leaflet, side effects, dosage

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

2. what you need to know before your child takes 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 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:

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.

• – 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]

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: One 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]

Convenient sachet combinations to achieve the single doses recommended in the dosing

table are provided below. Other combinations are possible.

260: One 110 mg plus one 150 mg sachet

110: One 110 mg sachet

140: One 30 mg plus one 110 mg sachet 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.

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 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 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Yellow Card Scheme

Website:or search for MHRA Yellow Card in the Google Play or Apple App Store

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- 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

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

United Kingdom

Boehringer Ingelheim Ltd.

Tel: +44 1344 424 600

Boehringer Ingelheim logo

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:

• Baby rice cereal, prepared with water
• Mashed carrots
• Apple sauce (for administration with apple juice see B))
• Mashed banana

Do not use soft food containing milk products.

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 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.

Step 6 – Administer soft food

• 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) _____________­________________________

• 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

• 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.