Dabigatran Etexilate

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.

Do not stop taking dabigatran unless directed by your doctor. If you stop taking this medication early, you have a higher risk of forming a serious blood clot (such as a stroke, blood clot in the legs/lungs). Your doctor may direct you to take a different "blood thinning" or antiplatelet medication to reduce your risk. Get medical help right away if you have weakness on one side of the body, trouble speaking, sudden vision changes, confusion, chest pain, trouble breathing, or pain/warmth/swelling in the legs.

People taking this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Before any spinal procedure, ask your doctor about the benefits and risks. The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/enoxaparin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).

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.

See also Warning section.

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

Remember that this medication has been prescribed because your doctor has judged that the benefit to you 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 your blood clotting proteins too much. Tell your doctor right away if you have 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 you have 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 your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

Do not share this medication with others.

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

See also Warning section.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking dabigatran and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice a day. Children should take the first dose in the morning and the second dose in the evening (about 12 hours apart). To prevent clots after hip or knee replacement surgery, take it as directed by your doctor, usually once a day. Avoid antacids within 24 hours after surgery, or dabigatran may not work as well. If you have stomach upset while taking this medication, take it with food.

Swallow the capsules whole with a full glass of water (8 ounces/240 milliliters). Do not crush, chew, or break open the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. Do not put this medication in a pill box or medication reminder box. It must be kept tightly closed in the original bottle (or blister package) to protect it from moisture. See also Storage section for more important details.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Children's dosage is also based on age and weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

It is very important to take it exactly as directed. Do not increase your dose or take this drug more often than directed. Do not stop taking this medication without consulting your doctor.

Before taking dabigatran, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your 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 having surgery or any medical/dental procedures (especially spinal puncture or spinal/epidural anesthesia), tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking 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 your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.

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. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. If you fall or injure yourself, especially if you hit your head, call your doctor right away. Your doctor may need to check you.

Older adults may be at greater risk for bleeding while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breastfeeding.

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 include: 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 your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of dabigatran from your 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.

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.

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

See also How to Use section.

Store in the original bottle at room temperature away from light and moisture. Do not store in the bathroom. Once the bottle is opened, this medication expires after 4 months. If your capsules are in a blister package, keep the medication in the blister package until ready to use. 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.