Uses

Dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery. Dabigatran is an anticoagulant that works by blocking a certain substance (a clotting protein called thrombin) in your blood. This helps to keep blood flowing smoothly in your body.

Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If you have had heart valve surgery, talk to your doctor about the best medication for you. Do not stop taking any medication, including dabigatran, without talking to your doctor first.

Other Uses

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.

How To Use

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, kidney function, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). For children, the dosage is also based on age and weight.

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.

Side Effects

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 www.fda.gov/medwatch.

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

Precautions

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 breast-feeding.

Drug Interactions

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 directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. 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.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

Notes

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.

Missed Dose

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

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

See also How to Use section.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep this medication in the original bottle. Do not put this medication in a pill box or medication reminder box. Open only one bottle at a time, and once the bottle is opened, the medication must be thrown away after 4 months. If your capsules are in a blister package, then keep the capsules in the blister package until you are ready to take the medication. 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.

Medical Alert

Your 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).