Package Insert: Information for the Patient

Pradaxa 20mg Coated Granule

Pradaxa 30mg Coated Granule

Pradaxa 40mg Coated Granule

Pradaxa 50mg Coated Granule

Pradaxa 110mg Coated Granule

Pradaxa 150mg Coated Granule

dabigatrán etexilato

Read this package insert carefully before your child starts taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your child's doctor or pharmacist.
• This medication has been prescribed only for your child, and should not be given to others who may have the same symptoms, as it may harm them.
• If your child experiences any adverse effects, consult your child's doctor or pharmacist, even if they are not listed in this package insert. See section4.

1. What is Pradaxa and how is it used

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

3. How to take Pradaxa

4. Possible adverse effects

5. Storage of Pradaxa

6. Contents of the package and additional information

Pradaxa contains the active ingredient dabigatrán etexilate and belongs to a group of medications known as 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 prevent the formation of new blood clots.

No use Pradaxa

‑If your child is allergic to dabigatran etexilate or any of the other components of this medication (listed in section6).

‑If your child's renal function is severely reduced.

‑If your child is currently experiencing bleeding.

‑If your child has any organ disease that increases the risk of severe bleeding (e.g., stomach ulcer, head 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 medications.

‑If your child is receiving medications to prevent blood clotting in the blood (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when changing anticoagulant treatment or while having a central venous or arterial catheter and heparin is administered through this catheter to keep it open.

‑If your child's liver function is severely reduced or if your child has any liver disease that may be fatal.

‑If your child is receiving ketoconazole or itraconazole orally, medications used in the treatment of fungal infections.

‑If your child is receiving oral ciclosporin, a medication used to prevent organ rejection after a transplant.

‑If your child is receiving dronedarone, a medication used to treat abnormal heart rhythm.

‑If your child is receiving a combination product of glecaprevir and pibrentasvir, an antiviral medication used to treat hepatitisC.

‑If your child has had a heart valve implanted that requires permanent anticoagulant treatment.

Warnings and Precautions

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

Inform your child's doctorif your child has or has had any disorder or disease, especially any of the following:

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

• If your child has recently experienced bleeding.
• If your child has had a recent surgical tissue extraction (biopsy) in the last month.
• If your child has suffered a severe injury (e.g., a bone fracture, a head injury, or any injury that required surgical treatment).
• If your child has an inflammation of the esophagus or stomach.
• If your child has problems with acid reflux in the esophagus.
• If your child is receiving medications that may increase the risk of bleeding. See “Other Medications and Pradaxa” below.
• If your child is receiving anti-inflammatory medications, such as diclofenac, ibuprofen, or piroxicam.
• If your child has a bacterial heart infection (endocarditis).
• If you know that your child has reduced kidney function or if your child is dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored, concentrated urine with foam).
• If your child has an infection in the brain or around it.

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

‑If your child has liver disease associated with changes in blood test results. The use of this medication is not recommended in this case.

Be especially careful with Pradaxa

‑If your child needs to undergo surgery:

In this case, Pradaxa should be temporarily interrupted due to an increased risk of bleeding during and shortly after surgery. It is very important that you administer Pradaxa exactly as instructed by your child's doctor before and after surgery.

‑If a surgical procedure requires the placement of a catheter or an injection in your child's spine (e.g., for epidural or spinal anesthesia or for pain relief):

• It is very important that you administer Pradaxa exactly as instructed by your child's doctor before and after surgery.
• Inform your child's doctor immediately if your child experiences numbness or weakness in the legs or intestinal or urinary problems after the end of anesthesia, as this situation requires urgent attention.

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

‑If you know that your child has a condition called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), inform your child's doctor to decide if the treatment needs to be modified.

Other Medications and Pradaxa

Inform your child's doctor or pharmacist if your child is receiving or has recently received any other medication.Particularly, inform your child's doctor before giving Pradaxaif your child is receiving any of the following medications:

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

‑Medications for the treatment of fungal infections (e.g., ketoconazole, itraconazole), except when applied to the skin.

‑Medications used in the treatment of abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil).

‑Medications to prevent organ rejection after a transplant (e.g., tacrolimus, ciclosporin).

‑A combination product of glecaprevir and pibrentasvir (an antiviral medication used to treat hepatitisC).

‑Anti-inflammatory and pain-relieving medications (e.g., acetylsalicylic acid, ibuprofen, diclofenac).

‑St. John's Wort, a medicinal herb for depression.

‑Antidepressant medications called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors.

‑Rifampicin or clarithromycin (two antibiotics).

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

‑Certain medications for the treatment of epilepsy (e.g., carbamazepine, phenytoin).

Administration of Pradaxa with food and drinks

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

Pregnancy and breastfeeding

This medication is indicated for use in children under 12years. The information on pregnancy and breastfeeding may not be relevant in the context of your child's treatment.

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

The natural breastfeeding period should be interrupted during treatment with Pradaxa.

Driving and operating machines

Pradaxa has no known effects on the ability to drive and operate machines.

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

Follow exactly the administration instructions of this medication as indicated by your child's doctor. If in doubt, consult your child's doctor again.

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

The recommended dose depends on the weight and age. Your child's doctor will determine the correct dose for your child. It is possible that your child's doctor will adjust the dose during treatment. Your child should continue to use all other medications unless your child's doctor tells you to stop using one.

The table 1 shows the single doses and total daily doses of Pradaxa in milligrams (mg) for patients under 12 months of age. The doses depend on the weight in kilograms (kg) and age in months of the patient.

Table 1:Posology table for Pradaxa granulated coated for patients under 12 months

The following combinations of sachets are suitable to obtain the recommended single doses as shown in the posology table. Other combinations are possible.

20 mg: one sachet of 20 mg60 mg: two sachets of 30 mg

30 mg: one sachet of 30 mg70 mg: one sachet of 30 mg plus one sachet of 40 mg

40 mg: one sachet of 40 mg80 mg: two sachets of 40 mg

50 mg: one sachet of 50 mg100 mg: two sachets of 50 mg

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

Table 2:Posology table for Pradaxa granulated coated for patients between 1 year and less than 12 years

The following combinations of sachets are suitable to obtain the recommended single doses as shown in the posology table. Other combinations are possible.

50 mg: one sachet of 50 mg140 mg: one sachet of 30 mg plus one sachet of 110 mg

60 mg: two sachets of 30 mg180 mg: one sachet of 30 mg plus one sachet of 150 mg

70 mg: one sachet of 30 mg plus one sachet of 40 mg220 mg: two sachets of 110 mg

80 mg: two sachets of 40 mg260 mg: one sachet of 110 mg plus one sachet of 150 mg

100 mg: two sachets of 50 mg300 mg: two sachets of 150 mg

110 mg: one sachet of 110 mg

Form and Route of Administration

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

Instructions for Use

See the detailed instructions for the use of this medication in the "Administration Instructions" section at the end of the leaflet.

Change of Anticoagulant Treatment

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

If You Give Your Child Too Much Pradaxa

Taking too much of this medication increases the risk of bleeding. Contact your child's doctor immediately if you have given your child too much of this medication. There are specific treatment options available.

If You Forget to Give Pradaxa to Your Child

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

A missed dose should be omitted if the remaining time before the next dose is less than 6 hours.

Do not give a double dose to compensate for missed doses.

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

If You Stop Giving Pradaxa to Your Child

Give Pradaxa exactly as prescribed. Do not stop giving this medication without consulting your child's doctor first, as the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your child's doctor if your child experiences indigestion after taking Pradaxa.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Pradaxa acts on blood clotting; therefore, most side effects are related to signs such as bruising or bleeding. Severe or life-threatening bleeding episodes may occur, which can cause disability, be potentially fatal, or even lead to death. In some cases, these bleeding episodes may not be apparent.

If your child experiences any episode of bleeding that does not stop on its own or if your child experiences signs of excessive bleeding (exceptional weakness, fatigue, pallor, dizziness, headache, or unexplained swelling), consult your child's doctor immediately. The 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 that causes difficulty breathing or dizziness.

The possible side effects are listed below, grouped by frequency of occurrence.

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

• Decreased number of red blood cells in the blood
• Decreased number of platelets in the blood
• Rash with dark, prominent, and itchy red bumps caused by an allergic reaction
• Sudden change in skin color and appearance
• Formation of bruises
• Nasal bleeding
• Reflux of stomach juice into the esophagus
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

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

Unknown frequency (frequency cannot be estimated from available data):

• Lack of white blood cells (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or wound, in a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Anomalies in liver function tests

Reporting of side effects

If your child experiences any type of side effect, consult your child's doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after “CAD.” The expiration date is the last day of the month indicated.

Before first use, do not open the aluminum pouch containing the Pradaxa coated granules to protect it from moisture.

Once the aluminum pouch containing the coated granules and desiccant is opened, the medication must be used within the 6months that follow. The opened packet cannot be stored and must be used immediately after opening.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Pradaxa

‑The active ingredient is dabigatrán. Each Pradaxa 20mg granulated coated tablet contains granulated coated with 20mg of dabigatrán etexilate (in the form of mesilate).

‑The active ingredient is dabigatrán. Each Pradaxa 30mg granulated coated tablet contains granulated coated with 30mg of dabigatrán etexilate (in the form of mesilate).

‑The active ingredient is dabigatrán. Each Pradaxa 40mg granulated coated tablet contains granulated coated with 40mg of dabigatrán etexilate (in the form of mesilate).

‑The active ingredient is dabigatrán. Each Pradaxa 50mg granulated coated tablet contains granulated coated with 50mg of dabigatrán etexilate (in the form of mesilate).

‑The active ingredient is dabigatrán. Each Pradaxa 110mg granulated coated tablet contains granulated coated with 110mg of dabigatrán etexilate (in the form of mesilate).

‑The active ingredient is dabigatrán. Each Pradaxa 150mg granulated coated tablet contains granulated coated with 150mg of dabigatrán etexilate (in the form of mesilate).

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

Appearance of the product and contents of the package

The Pradaxa granulated coated tablets contain a yellowish granulated coated tablet.

Each package of this medicine contains an aluminum bag that, in turn, contains 60aluminum foil blisters with Pradaxa granulated coated tablets and a desiccant (with the inscription “DO NOT EAT” [do not eat] included a pictogram and the inscription “SILICA GEL” [silica gel]).

Marketing Authorization Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Responsible for manufacturing

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last approval date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu

Administration instructions

Do not administer Pradaxa granulated coated tablets

• through syringes or feeding tubes
• with other foods or beverages that are not apple juice and soft foods as indicated below

Administer Pradaxa granulated coated tablets with soft foods or apple juice. The instructions are provided below in sections A) for soft foods and B) for apple juice.

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

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

If the patient incompletely ingests the prepared medicine, do not administer a second dose, wait for the next administration time.

1. Administration of Pradaxa granulated coated tablets with soft foods

The food must be at room temperature before mixing it with the granulated coated tablet. The medicine can be administered with one of the following soft foods:

• carrot puree
• apple compote (for administration with apple juice, seeB)
• banana puree

Do not use soft foods that contain dairy products.

Step1: Prepare a small cup or bowl

Step2: Take the (the) blister(s)

Step3: Open the (the) blister(s)

Step4: Pour the (the) blister(s)

Step5: Remove the soft food to mix the granulated coated tablet

Step6: Administer the soft food

1. Administration of Pradaxa granulated coated tablets with apple juice

Step1: Have a cup of apple juice ready before the next step

Step2: Take the (the) blister(s)

Step3: Open the (the) blister(s)

Step4: Administer Pradaxa granulated coated tablets with apple juice

• Administer all the granulated coated tablets directly from the blister or using a spoon in the patient's mouth and offer the patient the amount of apple juice they need to swallow the granulated coated tablets.
• Examine the patient's mouth to ensure that they have swallowed all the granulated coated tablets.
• Optional: If Pradaxa granulated coated tablets are mixed in the apple juice cup, start with a small amount of apple juice (that is likely to be completely consumed by the child) and ensure that they take all the granulated coated tablets. If the granulated coated tablets stick to the cup, add another small amount of apple juice and give it to the child again. Repeat the process until no granulated coated tablets stick to the cup.