Pradaxa 40 mg coated granules

Package leaflet: Information for the user

Introduction

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 the entire leaflet carefully before your child starts taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your child's doctor or pharmacist.
• This medicine has been prescribed only for your child; do not give it to others, even if they have the same symptoms as your child, since it could harm them.
• If your child experiences any adverse effects, consult your child's doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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 involved in the formation of blood clots.

Pradaxa is used in children to treat blood clots and to prevent the formation of new blood clots.

2. What you need to know before your child starts taking Pradaxa

Do not use Pradaxa

‑ if your child is allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).

‑ if your child's kidney function is severely reduced.

‑ if your child is currently experiencing bleeding.

‑ if your child has a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).

‑ if your child is prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medicines.

‑ if your child is receiving medicines to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant treatment or while having a venous or arterial catheter with heparin administered through the catheter to keep it open.

‑ if your child's liver function is severely reduced or your child has a liver disease that could be life-threatening.

‑ if your child is taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.

‑ if your child is taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.

‑ if your child is taking dronedarone, a medicine used to treat abnormal heart rhythm.

‑ if your child is taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.

‑ if your child has had an artificial heart valve implanted that requires lifelong anticoagulant therapy.

Warnings and precautions

Talk to your child's doctor before starting Pradaxa. During treatment with this medicine, you may also need to consult your child's doctor if your child experiences any symptoms or needs to undergo surgery.

Tell your child's doctor if your child has or has had any disorder or illness, especially any of the following:

‑ If your child has an increased risk of bleeding, for example:

• if your child has recently had bleeding.
• if your child has undergone a surgical tissue removal (biopsy) within the last month.
• if your child has suffered a serious injury (e.g., bone fracture, head injury, or any injury requiring surgical treatment).
• if your child has inflammation of the esophagus or stomach.
• if your child has problems with gastric juice reflux into the esophagus.
• if your child is taking medicines that could increase the risk of bleeding. See "Other medicines and Pradaxa" below.
• if your child is taking anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.
• if your child has an infection in the heart (bacterial endocarditis).
• if you know your child has reduced kidney function or if your child is dehydrated (symptoms include feeling thirsty and passing small amounts of dark [concentrated]/foamy urine).
• if your child has an infection in or around the brain.

‑ If your child has had a heart attack or has been diagnosed with conditions that increase the risk of having a heart attack.

‑ If your child has a liver disease associated with changes in blood tests. Use of this medicine is not recommended in this case.

Take special care with Pradaxa

‑ If your child needs to undergo surgery:

In this case, Pradaxa should be temporarily stopped due to an increased risk of bleeding during and shortly after surgery. It is very important to give Pradaxa to your child exactly at the times instructed by your child's doctor, both before and after surgery.

‑ If surgery requires placement of a catheter or an injection into your child's spine (e.g., for epidural or spinal anaesthesia or for pain relief):

• It is very important to give Pradaxa to your child exactly at the times instructed by your child's doctor, both before and after the procedure.
• Inform your child's doctor immediately if your child develops numbness or weakness in the legs or problems with the intestines or bladder after the anaesthesia wears off, as this situation requires urgent medical attention.

‑ If your child falls or is injured during treatment, especially if they hit their head. Seek urgent medical help. Your child may need to be examined by a doctor, as they may have an increased risk of bleeding.

‑ If you know your child has a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your child's doctor so they can decide whether treatment adjustments are needed.

Other medicines and Pradaxa

Tell your child's doctor or pharmacist if your child is taking or has recently taken any other medicines. In particular, you must inform your child's doctor before taking Pradaxa if your child is taking any of the following medicines:

‑ Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)

‑ Medicines for fungal infections (e.g., ketoconazole, itraconazole), except when applied only to the skin

‑ Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

‑ Medicines used 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-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac)

‑ St. John's wort, a herbal remedy for depression

‑ Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors

‑ Rifampicin or clarithromycin (two antibiotics)

‑ Antiviral medicines for HIV (e.g., ritonavir)

‑ Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin)

Taking Pradaxa with food and drink

Do not mix the coated Pradaxa granules with milk or soft foods containing dairy products. Use this medicine only with apple juice or with one of the soft foods listed in the administration instructions at the end of the leaflet.

Pregnancy and breastfeeding

This medicine is intended for use in children under 12 years of age. Information regarding pregnancy and breastfeeding may not be relevant in the context of your child's treatment.

The effects of Pradaxa on pregnancy and the unborn child are unknown. A pregnant woman should not take this medicine unless her doctor tells her it is safe to do so. Women of childbearing age should avoid becoming pregnant during treatment with Pradaxa.

Natural breastfeeding should be discontinued during treatment with Pradaxa.

Driving and using machines

Pradaxa has no known effects on the ability to drive or operate machinery.

3. How to take Pradaxa

Pradaxa coated granules can be used in children under 12 years of age as soon as they are able to swallow soft foods. Pradaxa capsules are available for treatment of children 8 years of age or older.

Follow exactly the instructions given by your child's doctor for administering this medicine. If you have any doubts, consult your child's doctor again.

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

The recommended dose depends on body weight and age. Your child's doctor will determine the correct dose for your child. Your child's doctor may adjust the dose during treatment. Your child should continue taking all other medications unless your child's doctor instructs otherwise.

Table 1 shows the single doses and total daily doses of Pradaxa in milligrams (mg) for patients under 12 months of age. The doses are based on the patient's body weight in kilograms (kg) and age in months.

Table 1: Dosing table for Pradaxa coated granules for patients under 12 months of age

Weight/Age Combinations	Single Dose in mg	Total 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 month	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 12 months	100	200

The following are suitable sachet combinations to achieve the recommended single doses in the dosing table. Other combinations are possible.

20 mg: one 20 mg sachet
60 mg: two 30 mg sachets

30 mg: one 30 mg sachet
70 mg: one 30 mg sachet plus one 40 mg sachet

40 mg: one 40 mg sachet
80 mg: two 40 mg sachets

50 mg: one 50 mg sachet
100 mg: two 50 mg sachets

Table 2 shows the single doses and total daily doses of Pradaxa in milligrams (mg) for patients from 1 year to less than 12 years of age. The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 2: Dosing table for Pradaxa granules for patients from 1 year to less than 12 years of age

Weight/Age Combinations	Single Dose in mg	Total 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
More than 81 kg	10 to less than 12 years	300	600

Below are suitable sachet combinations to achieve the recommended single doses listed in the dosing table. Other combinations are possible.

50 mg: one 50 mg sachet
140 mg: one 30 mg sachet plus one 110 mg sachet
60 mg: two 30 mg sachets
180 mg: one 30 mg sachet plus one 150 mg sachet
70 mg: one 30 mg sachet plus one 40 mg sachet
220 mg: two 110 mg sachets
80 mg: two 40 mg sachets
260 mg: one 110 mg sachet plus one 150 mg sachet
100 mg: two 50 mg sachets
300 mg: two 150 mg sachets
110 mg: one 110 mg sachet

Method and route of administration

This medicine should be administered with apple juice or with one of the soft foods indicated in the administration instructions. Do not mix this medicine with milk or with soft foods containing dairy products.

Detailed instructions for using this medicine are provided in the section “Administration instructions” at the end of the leaflet.

Changing anticoagulant treatment

Do not change your child's anticoagulant treatment without specific instructions from your child's doctor.

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 administered an excessive amount of this medicine. Specific treatment options are available.

If you forget to give Pradaxa to your child

A missed dose can be administered up to 6 hours before the next scheduled dose.

A missed dose should be omitted if less than 6 hours remain before the next dose.

Do not administer a double dose to make up for missed doses.

If a dose was only partially taken, do not attempt to administer a second dose at that time. Administer the next dose at the scheduled time, approximately 12 hours later.

If you stop treatment with Pradaxa

Administer Pradaxa exactly as prescribed. Do not stop treatment with this medicine without first consulting your child's doctor, as the risk of developing a blood clot may be higher if treatment is stopped too early. Contact your child's doctor if your child experiences indigestion after taking Pradaxa.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Pradaxa acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Major or serious bleeding episodes may occur, which represent the most serious adverse effects and, regardless of their location, may cause disability, may be potentially fatal, or even result in death. In some cases, this bleeding may not be obvious.

If your child experiences any bleeding episode that does not stop on its own, or if your child shows signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your child's doctor immediately. Your child's doctor may decide to keep your child under close observation or change the medication.

Inform your child's doctor immediately if your child experiences a severe allergic reaction causing difficulty breathing or dizziness.

The possible adverse effects are listed below, grouped according to their frequency of occurrence.

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash with dark red, raised, itchy bumps caused by an allergic reaction
• Sudden change in the skin affecting its color and physical appearance
• Bruising
• Nosebleeds
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling nauseous
• Frequent loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in the urine which may turn the urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum with blood streaks
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

Frequency not known (frequency cannot be estimated from available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, surgical incision, injection site, or at the site of a venous catheter insertion
• Bleeding from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormalities in liver function tests

Reporting of adverse effects

If your child experiences any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pradaxa

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

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

Once the aluminium pouch containing the coated granules and the desiccant has been opened, the medicine must be used within 6 months. An opened sachet cannot be stored and must be used immediately after opening.

Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pradaxa

• The active substance is dabigatran. Each sachet of Pradaxa 20 mg coated granules contains coated granules with 20 mg of dabigatran etexilate (as mesilate).

• The active substance is dabigatran. Each sachet of Pradaxa 30 mg coated granules contains coated granules with 30 mg of dabigatran etexilate (as mesilate).

• The active substance is dabigatran. Each sachet of Pradaxa 40 mg coated granules contains coated granules with 40 mg of dabigatran etexilate (as mesilate).

• The active substance is dabigatran. Each sachet of Pradaxa 50 mg coated granules contains coated granules with 50 mg of dabigatran etexilate (as mesilate).

• The active substance is dabigatran. Each sachet of Pradaxa 110 mg coated granules contains coated granules with 110 mg of dabigatran etexilate (as mesilate).

• The active substance is dabigatran. Each sachet of Pradaxa 150 mg coated granules contains coated granules with 150 mg of dabigatran etexilate (as mesilate).

• The other components are tartaric acid, arabic gum, hypromellose, dimethicone 350, talc and hydroxypropylcellulose.

Appearance of the product and contents of the pack

The sachets of Pradaxa coated granules contain a yellowish coated granular powder.

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

Marketing Authorization 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Boehringer Ingelheim SComm Tel/Tel: +32 2 773 33 11	Lithuania Boehringer Ingelheim RCV GmbH & Co KG Lithuanian Branch Tel: +370 5 2595942
Bulgaria Boehringer Ingelheim Bulgaria EOOD Tel: +359 2 958 79 98	Luxembourg/Luxembourg Boehringer Ingelheim SComm Tel/Tel: +32 2 773 33 11
Czech Republic Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111	Hungary Boehringer Ingelheim RCV GmbH & Co KG Hungarian Branch Tel: +36 1 299 8900
Denmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88	Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620
Germany Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900	Netherlands Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 889
Estonia Boehringer Ingelheim RCV GmbH & Co KG Estonian Branch Tel: +372 612 8000	Norway Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00
Greece Boehringer Ingelheim Hellas Monoprosopia E.E. Tel: +30 2 10 89 06 300	Austria Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105‑7870
Spain Boehringer Ingelheim España S.A. Tel: +34 93 404 51 00	Poland Boehringer Ingelheim Sp. z o.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
Croatia Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600	Romania Boehringer Ingelheim RCV GmbH & Co KG Vienna – Bucharest Branch Tel: +40 21 302 2800
Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620	Slovenia Boehringer Ingelheim RCV GmbH & Co KG Ljubljana Branch Tel: +386 1 586 40 00
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Boehringer Ingelheim RCV GmbH & Co KG Organizational Unit Slovakia Tel: +421 2 5810 1211
Italy Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1	Finland Boehringer Ingelheim Finland Ky Tel/Puh: +358 10 3102 800
Cyprus Boehringer Ingelheim Hellas Monoprosopia E.E. Tel: +30 2 10 89 06 300	Sweden Boehringer Ingelheim AB Tel: +46 8 721 21 00
Latvia Boehringer Ingelheim RCV GmbH & Co KG Latvian Branch Tel: +371 67 240 011	United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620

Date of the most recent approval of this package leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Instructions for administration

Do not administer Pradaxa granules

• via syringes or feeding tubes
• with other foods or drinks than apple juice and soft foods as indicated below

Administer Pradaxa granules with soft foods or apple juice. Instructions are provided below under sections A) for soft foods and B) for apple juice.

The prepared medicine should be administered before meals to ensure the patient takes the full dose.

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

If the patient does not fully ingest the prepared medicine, do not administer a second dose; wait until the next scheduled administration.

1. Administration of Pradaxa granules with soft foods

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

• carrot purée
• apple purée (for administration with apple juice, see B)
• banana purée

Do not use soft foods containing dairy products.

Step 1: Prepare a cup or bowl

Transfer two teaspoons of the soft food to a small bowl or cup.

Step 2: Take the sachet(s)

Upon first opening, cut open the silver aluminum pouch at the top with scissors. The aluminum pouch contains 60 silver sachets (medicinal product) and a desiccant with the inscription “DO NOT EAT” included a pictogram and the inscription “SILICA GEL”.
Do not open or consume the desiccant.
Take the required number of Pradaxa granules sachets according to the prescribed dose. Return unused sachets back into the aluminum pouch.

Step 3: Open the envelope(s)

Take the sachet containing Pradaxa granules. Gently tap the sachet on the table to ensure the contents settle at the bottom. Hold the sachet in an upright position. Open the sachet by cutting along the top edge with scissors.

Step 4: Pour the sachet(s)

Empty the entire contents of the packet into the small cup or bowl containing the soft food. Repeat steps 3 and 4 if more than one packet is needed.

Step 5: Remove the soft food to mix the coated granules

Remove the soft food with the feeding spoon to mix the coated granules thoroughly with the soft food.

Step 6: Administer the soft food

Administer the soft food with the coated granules to the patient immediately using the feeding spoon. Ensure that all the soft food has been taken.

1. Administration of Pradaxa coated granules with apple juice

Step 1: Have a cup of apple juice ready before proceeding to the next step

Step 2: Take the sachet(s)

Upon first opening, cut open the silver aluminum pouch at the top using scissors. The aluminum pouch contains 60 silver sachets (medicinal product) and a desiccant marked “DO NOT EAT” including a pictogram and the inscription “SILICA GEL”.
Do not open or consume the desiccant.
Take the required number of Pradaxa coated granules sachets according to the prescribed dose. Return unused sachets to the aluminum pouch.

Step 3: Open the envelope(s)

Take the sachet containing Pradaxa granules. Gently tap the sachet on the table to ensure the contents settle at the bottom. Keep the sachet in an upright position. Open the sachet by cutting along the top edge with scissors.

Step 4: Administer Pradaxa coated granules with apple juice

• Administer all 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.
• Examine the child's mouth to ensure that all the coated granules have been swallowed.
• Optional: If mixing Pradaxa coated granules in a cup of apple juice, start with a small amount of apple juice (an amount your child is likely to drink completely) and ensure that all the coated granules are taken. If the coated granules stick to the cup, add another small amount of apple juice and give it to your child again. Repeat this process until no coated granules remain adhered to the cup.