InfoCons Consumer Protection informs you – Pradaxa – Package Leaflet

Before anything else

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 pha rmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 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

Do not usePradaxa

• 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 increa sed 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 havi ng 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.

217- 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 chil d 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 rem oval (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 wit h 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 b e 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 you r 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, e specially 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.

218- if you know that your child has a disease called antiphospholipid syndrom e (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, cyclospori ne)
• 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 depres sion
• 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 treat ment 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 administration 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 12years as soon as they are able to swallow soft food . Pradaxa capsules are available for the treatment of children aged 8years 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.

219Pradaxa 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 child’s doctor will determine the correct dose. 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.

Table 1 shows s ingle and total daily Pradaxa dose sin milligrams (mg) for patients below 12months .

The dose sdepend on weight in kilograms (kg) and age in months of the patient .

Table 1: Dosing table for Pradaxa coated granules for patients below 12 months Weight /age combinations Single dose in mgTotal daily dose in mg Weight in kg Age in MONTHS 2.5 to less than 3 kg 4 to less than 5 months 20 40 3 to less than 4 kg 3 to less than 6 months 20 40 4 to less than 5 kg 1 to less than 3 months 20 40 3 to less than 8 months 30 60 8 to less than 10 months 40 80 5 to less than 7 kg 0 to less than 1 months 20 40 1 to less than 5 months 30 60 5 to less than 8 months 40 80 8 to less than 12 months 50 100 7 to less than 9 kg 3 to less than 4 months 40 80 4 to less than 9 months 50 100 9 to less than 12 months 60 120 9 to less than 11 kg 5 to less than 6 months 50 100 6 to less than 11 months 60 120 11 to less than 12 months 70 140 11 to less than 13 kg 8 to less than 10 months 70 140 10 to less than 12 months 80 160 13 to less than 16 kg 10 to less than 11 months 80 160 11 to less than 12months 100 200 Convenient sachet combinations to achieve the single doses recommended in the dosing table are provided below. Other combinations are possible.

20mg: One 20 mg sachet 60mg: Two 30 mg sachets 30mg: One 30 mg sachet 70mg: One 30 mg plus one 40 mg sachet 40mg: One 40 mg sachet 80mg: Two 40 mg sachets 50mg: One 50 mg sachet 100mg: Two 50 mg sachets Table 2 shows s ingle and total daily Pradaxa dose sin milligrams (mg) for patients from 1 year to less than 12years . The dose sdepend on weight in kilograms (kg) and age in years of the patient .

220Table 2: Dosing table for Pradaxa coated granules for patients from 1 year to less than 12 years Weight /age combinations Single dose in mgTotal daily dose in mg Weight in kg Age in YEARS 5 to less than 7 kg 1 to less than 2 years 50 100 7 to less than 9 kg 1 to less than 2 years 60 120 2 to less than 4 years 70 140 9 to less than 11 kg 1 to less than 1.5 years 70 140 1.5 to less than 7 years 80 160 11 to less than 13 kg 1 to less than 1.5 years 80 160 1.5 to less than 2.5 years 100 200 2.5 to less than 9 years 110 220 13 to less than 16 kg 1 to less than 1.5 years 100 200 1.5 to less than 2 years 110 220 2 to less than 12 years 140 280 16 to less than 21 kg 1 to less than 2 years 110 220 2 to less than 12 years 140 280 21 to less than 26 kg 1.5 to less than 2 years 140 280 2 to less than 12 years 180 360 26 to less than 31 kg 2.5 to less than 12 years 180 360 31 to less than 41 kg 2.5 to less than 12 years 220 440 41 to less than 51 kg 4 to less than 12 years 260 520 51 to less than 61 kg 5 to less than 12 years 300 600 61 to less than 71 kg 6 to less than 12 years 300 600 71 to less than 81 kg 7 to less than 12 years 300 600 above 81 kg 10 to less than 12years 300 600 Convenient sachet combinations to achieve the single doses recommended in the dosing table are provided below. Other combinations are possible.

50mg: One 50 mg sachet 140mg: One 30 mg plus one 110 mg sachet 60mg: Two 30 mg sachets 180mg: One 30 mg plus one 150 mg sachet 70mg: One 30 mg plus one 40 mg sachet 220mg: Two 110 mg sachets 80mg: Two 40 mg sachets 260mg: One 110 mg plus one 150 mg sachet 100mg: Two 50 mg sachets 300mg: Two 150 mg sachets 110mg: One 110 mg sachet 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 administration .Do not mix this medicine with milk or soft food containing milk products.

Detailed i nstructions for the use of this medicine are provided in ‘Instructions for administration ’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.

221If 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 you rchild experience sindigestion after giving Pradaxa.

If you have any fur ther 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 ch ild’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 o r dizziness.

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

Common (may affect up to1 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 moveme nts
• Indigestion
• Hair loss
• Liver enzymes increased

Uncommon (may affect up to1 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, fro m 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) 222- A decrease in the proportion of blood cells
• Itching
• Coug hing 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 i n 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. Y ou can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide mo re 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 mea sures 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 223coated granules with 50 mg dabigatran etexilate (as mesilate).
• The active substance is dabig atran. 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 dabigatra n 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 contain san aluminium bag which in turn contains 60 silver -coloured aluminium sachets with Pradaxa coated granules and adesiccant (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 224For any information about this medicin e, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595942 България Бьорингер Ингелхайм РЦВ ГмбХ и Ко. КГ – клон България Тел: +359 2 958 79 98Luxembourg/Luxemburg Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11 Česká republika Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111Magyarország Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Tel: +36 1 299 8900 Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88Malta Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620 Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900Nederland Boehringer Ingelheim B.V.

Tel: +31 (0) 800 22 55 889 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8000Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00 Ελλάδα Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.

Tηλ: +30 2 10 89 06 300Österreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105 -7870 España Boehringer Ingelheim España S.A.

Tel: +34 93 404 51 00Polska Boehringer Ingelheim Sp.zo.o.

Tel: +48 22 699 0 699 France Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33Portugal Boehringer Ingelheim Portugal , Lda.

Tel: +351 21 313 53 00 Hrvatska Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600România Boehringer Ingelheim RCV GmbH & Co KG Viena -Sucursala Bucuresti Tel: +40 21 302 2800 Ireland Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana Tel: +386 1 586 40 00 Ísland Vistor hf.

Sími : +354 535 7000Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka Tel: +421 2 5810 1211 225Italia Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 800 Κύπρος Boehringer Ingelheim Ελλάς Μονοπρόσωπη Α.Ε.

Tηλ: +30 2 10 89 06 300Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 00 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle Tel: +371 67 240 011United 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: http://www.ema.europa.eu / 226Instructions for administration 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 medic ineshould be given before meals in order to ensure that the patient takes the full dose.

Administer the prepared medicine to the patien t 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 medic ine, do not apply a second dose, wait until the next dosing time -point.

A) Adm inistration of Pradaxa coated granules with soft foods The food should be at room temperature before mixing with the coated granules. The medic inecan 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 soft food 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 60silver -coloured sachets (medicine) and one desiccant with the imprint “ DO NOT EAT” including pictogram and “SILICA GEL ”.

227 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.

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.

228Step 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  Administer the soft food with the coated granules to the patient immediately using the feeding spoon.  Assure that all soft food is eaten.

B) Adm inistration 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 60silver -coloured sachets (medicine) and one desic cant with the imprint “ DO NOT EAT” including pictogram and “SILICA GEL ”.  Do not open or consume the desiccant.

229 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 –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 anoth er small amount of apple juice and again apply to your child. Repeat until no remaining coated granules are sticking to the cup.

230PATIENT ALERT CARD [for Pradaxa 75 mg/110mg/150mg capsules] Pradaxa®capsules dabigatran etexilate  This card should be with you / the caregiver at all times  Make sure to use the latest version [xxxx 20 xx] [Boehringer Ingelheim logo] Dear Patient /Caregiver of a paediatric patient , Your /your child’s doctor has initiated treatment with Pradaxa®. In order to use Prada xa®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 b lood 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 bleedin g cuts, abnormal menstrual flow or vaginal bleeding, blood in theurine which may be pink or brown, red/black stools, coughing up blood, vomiting blood or coffee ground like material.
• In case of fall or injur y, 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 inhibito r).
• 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 ant agoni se the anticoagulant effect of Pradaxa®please refer to the Summary of Product Characteristics of Pradaxa®and idarucizumab .

231• 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 anticoagulati on _________________________________ Dose of Pradaxa® 232PATIENT 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 20xx] [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 administration 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 bleedin g, 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 n ot 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.

233Please 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®

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Pradaxa (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/08/442).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.