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.
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 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 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 switching from one anticoagulant to another or while having a central venous or arterial catheter and receiving heparin through this catheter to keep it open.
‑If your child's liver function is severely reduced or if your child has a 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 an artificial heart valve 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 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 a liver disease associated with changes in blood tests. 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 into your child's spine (e.g., for epidural or spinal anesthesia or for pain relief):
‑If your child falls or is injured during treatment, especially if they hit their head. Seek immediate 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 disease 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.Especially, 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).
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. In case of 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 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 patient's weight in kilograms (kg) and age in months.
Table 1:Table of posology for Pradaxa granulated coated for patients under 12 months
Weight/Age Combinations | Single Dose in mg | Total Daily Dose in mg | |
Weight in kg | Age in MONTHS | ||
2.5 to less than 3 kgkg | 4 to less than 5 monthsmonths | 20 | 40 |
3 to less than 4 kgkg | 3 to less than 6 monthsmonths | 20 | 40 |
4 to less than 5 kgkg | 1 to less than 3 monthsmonths | 20 | 40 |
3 to less than 8 monthsmonths | 30 | 60 | |
8 to less than 10 monthsmonths | 40 | 80 | |
5 to less than 7 kgkg | 0 to less than 1 monthmonths | 20 | 40 |
1 to less than 5 monthsmonths | 30 | 60 | |
5 to less than 8 monthsmonths | 40 | 80 | |
8 to less than 12 monthsmonths | 50 | 100 | |
7 to less than 9 kgkg | 3 to less than 4 monthsmonths | 40 | 80 |
4 to less than 9 monthsmonths | 50 | 100 | |
9 to less than 12 monthsmonths | 60 | 120 | |
9 to less than 11 kgkg | 5 to less than 6 monthsmonths | 50 | 100 |
6 to less than 11 monthsmonths | 60 | 120 | |
11 to less than 12 monthsmonths | 70 | 140 | |
11 to less than 13 kgkg | 8 to less than 10 monthsmonths | 70 | 140 |
10 to less than 12 monthsmonths | 80 | 160 | |
13 to less than 16 kgkg | 10 to less than 11 monthsmonths | 80 | 160 |
11 to less than 12 monthsmonths | 100 | 200 |
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 patient's weight in kilograms (kg) and age in years.
Table 2:Table of posology for Pradaxa granulated coated for patients between 1 year and less than 12 years
Weight/Age Combinations | Single Dose in mg | Total Daily Dose in mg | |
Weight in kg | Age in YEARS | ||
5 to less than 7 kgkg | 1 to less than 2 yearsyears | 50 | 100 |
7 to less than 9 kgkg | 1 to less than 2 yearsyears | 60 | 120 |
2 to less than 4 yearsyears | 70 | 140 | |
9 to less than 11 kgkg | 1 to less than 1.5 yearsyears | 70 | 140 |
1.5 to less than 7 yearsyears | 80 | 160 | |
11 to less than 13 kgkg | 1 to less than 1.5 yearsyears | 80 | 160 |
1.5 to less than 2.5 yearsyears | 100 | 200 | |
2.5 to less than 9 yearsyears | 110 | 220 | |
13 to less than 16 kgkg | 1 to less than 1.5 yearsyears | 100 | 200 |
1.5 to less than 2 yearsyears | 110 | 220 | |
2 to less than 12 yearsyears | 140 | 280 | |
16 to less than 21 kgkg | 1 to less than 2 yearsyears | 110 | 220 |
2 to less than 12 yearsyears | 140 | 280 | |
21 to less than 26 kgkg | 1.5 to less than 2 yearsyears | 140 | 280 |
2 to less than 12 yearsyears | 180 | 360 | |
26 to less than 31 kgkg | 2.5 to less than 12 yearsyears | 180 | 360 |
31 to less than 41 kgkg | 2.5 to less than 12 yearsyears | 220 | 440 |
41 to less than 51 kgkg | 4 to less than 12 yearsyears | 260 | 520 |
51 to less than 61 kgkg | 5 to less than 12 yearsyears | 300 | 600 |
61 to less than 71 kgkg | 6 to less than 12 yearsyears | 300 | 600 |
71 to less than 81 kgkg | 7 to less than 12 yearsyears | 300 | 600 |
More than 81 kgkg | 10 to less than 12 yearsyears | 300 | 600 |
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 this 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. 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 medication without consulting your child's doctor, as the risk of developing a blood clot may be higher if treatment is stopped 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 bleeding episode that does not stop on its own or if your child experiences signs of excessive bleeding (exceptional weakness, fatigue, paleness, 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):
Rare (may affect up to 1 in 100 people):
Unknown frequency (frequency cannot be estimated from available data):
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 about 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.
Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and unused medications. This 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:
Belgium/Belgique/Belgien Boehringer Ingelheim SComm | Lithuania Boehringer Ingelheim RCV GmbH & Co KG Lithuanian branch Tel: +370 5 2595942 |
Bulgaria Boehringer IngelheimBulgaria EOOD Tel: +359 2 958 79 98 | Luxembourg/Luxemburg Boehringer Ingelheim SComm |
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 Tel: +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 IngelheimB.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 Tel: +47 66 76 13 00 |
Greece Boehringer IngelheimGreeceMonoprosopon A.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.zo.o. Tel: +48 22 699 0 699 |
France Boehringer Ingelheim France S.A.S. Tel: +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‑Sucursal Bucuresti Tel: +40 21 302 2800 |
Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620 | Slovenia Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana Tel: +386 1 586 40 00 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia Boehringer Ingelheim RCV GmbH & Co KG organisational unit Tel: +421 2 5810 1211 |
Italy Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 | Finland Boehringer Ingelheim Finland Ky Tel: +358 10 3102 800 |
Cyprus Boehringer IngelheimGreeceMonoprosopon A.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 |
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
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.
The food must be at room temperature before mixing it with the granulated coated tablets. The medicine can be administered with one of the following soft foods:
Do not use soft foods that contain dairy products.
Step1: Prepare a small bowl or cup
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Step2: Take the (the) blister(s)
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Step3: Open the (the) blister(s)
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Step4: Pour the (the) blister(s)
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Step5: Remove the soft food to mix the granulated coated tablets
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Step6: Administer the soft food
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Step1: Have a cup of apple juice ready before the next step
Step2: Take the (the) blister(s)
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Step3: Open the (the) blister(s)
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Step4: Administer Pradaxa granulated coated tablets with apple juice
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