Pradaxa

See also Warning section.

Easy bruising, minor bleeding (such as nosebleed, bleeding from cuts), diarrhea, upset stomach, or heartburn may occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause serious bleeding if it affects the blood clotting proteins too much. Tell the doctor right away if your child has any signs of serious bleeding, including: nosebleeds that happen often or don't stop, unusual tiredness/weakness, unusual pain/swelling/discomfort, unusual/easy bruising, prolonged bleeding from cuts or gums, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, bloody/black/tarry stools.

Get medical help right away if your child has any signs of very serious bleeding, including: vision changes, confusion, trouble speaking, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US -

Call the doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call the doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before giving dabigatran, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: mechanical heart valve, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), liver disease, recent major injury/surgery, stroke, a certain clotting disorder (antiphospholipid syndrome), frequent falls/injuries.

Before your child has surgery or any medical/dental procedures (especially spinal puncture or spinal/epidural anesthesia), tell the doctor or dentist that your child is taking this medication and about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products). The doctor or dentist may tell you to stop giving dabigatran before your surgery. Ask for specific instructions about stopping or starting this medication.

This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase the risk for stomach bleeding. Avoid alcoholic beverages.

This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Your child should use an electric razor when shaving and a soft toothbrush when brushing their teeth. If your child falls or is injured, especially if your child hits their head, call the doctor right away. The doctor may need to check your child.

This form of dabigatran is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult the doctor if you have any questions about this medication.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep the packets in the aluminum bag until you are ready to give the medication. After opening the aluminum bag, discard the desiccant found in the bag. Once the aluminum bag is opened, this medication expires after 6 months. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to reduce the risk of blood clots forming in your legs or lungs after knee replacement surgery.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, clotting times) may be done while your child is taking this medication. Keep all medical and lab appointments. Consult the doctor for more details.

If your child misses a dose, give it as soon as you remember. If it is less than 6 hours before the next dose, skip the missed dose. Give the next dose at the regular time. Do not double the dose to catch up.

Your child's condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: mifepristone, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/apixaban).

Aspirin can increase the risk of bleeding when used with this medication. However, if the doctor has told you to give aspirin, your child should keep taking the aspirin unless the doctor tells you not to. Ask the doctor or pharmacist for more details.

Other medications can affect the removal of dabigatran from the body, which may affect how dabigatran works. Examples include cobicistat, cyclosporine, dronedarone, ketoconazole, rifampin, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.