Patient leaflet - Pradaxa 75 mg hard capsules
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.
‑ 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 it is 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
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
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. Pradaxa coated granules are available for the treatment of children below 12 years as soon as they are able to swallow soft food.
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 weight and age. 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.
Table 1 shows single and total daily Pradaxa doses in milligrams (mg). The doses depend on weight in kilograms (kg) and age in years of the patient.
Table 1: Dosing table for Pradaxa capsules
Weight / age combinations Single dose
in mg
Total daily dose in mg
Weight in kg Age in years
11 to less than 13 kg 8 to less than 9 years 75 150 13 to less than 16 kg 8 to less than 11 years 110 220 16 to less than 21 kg 8 to less than 14 years 110 220 21 to less than 26 kg 8 to less than 16 years 150 300 26 to less than 31 kg 8 to less than 18 years 150 300 31 to less than 41 kg 8 to less than 18 years 185 370 41 to less than 51 kg 8 to less than 18 years 220 440 51 to less than 61 kg 8 to less than 18 years 260 520 61 to less than 71 kg 8 to less than 18 years 300 600 71 to less than 81 kg 8 to less than 18 years 300 600 81 kg or greater 10 to less than 18 years 300 600 Single doses requiring combinations of more than one capsule: 300 mg: two 150 mg capsules or
four 75 mg capsules
260 mg: one 110 mg plus one 150 mg capsule or
one 110 mg plus two 75 mg capsules
220 mg: two 110 mg capsules
185 mg: one 75 mg plus one 110 mg capsule
150 mg: one 150 mg capsule or
two 75 mg capsules
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
1 Tear off one individual blister from the blister card along the
perforated line
2 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
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.
abcd
Pradaxa®
75 mg hard capsules
dabigatran etexilate
abcd
Pradaxa® 75 mg hard capsules
dabigatran etexilate
abcd
MASS D: 0,5 mm
MASS E: 1,5 mm
MASS G: 1,0 mm
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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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard 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, 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
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
This leaflet was last revised in 02/2024. 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® 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
February 2024
PATIENT ALERT CARD
Pradaxa® capsules dabigatran etexilate
- This card should be with you / the caregiver at all times
Make sure to use the latest version
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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®
5
7 4
6