Dabigatran Etexilate Mesylate (da-bi-GAT-ran e-TEX-i-late MES-i-late)

Reduces the risk of stroke, and treats and prevents blood clots. This medicine is an anticoagulant (blood thinner).

Brand Name(s):

Pradaxa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Pellet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole with a full glass of water. Do not crush, break, chew, or open it.
• Oral pellets:
  • If you take this medicine directly in your mouth, drink apple juice after swallowing the pellets.
  • You may mix the oral pellets with 1 to 2 ounces of apple juice or with 2 teaspoons of soft foods at room temperature (including apple sauce, mashed banana, or mashed carrots). Take the mixture within 30 minutes.
  • Throw away the mixture if you have not taken it within 30 minutes of mixing.
  • Do not mix this medicine together with milk or foods containing milk. Do not give this medicine through syringes or feeding tubes.
  • Take this medicine before meals to make sure you get the full dose.
• If you are taking this medicine 2 times a day, take one dose in the morning and one dose in the evening, at least 12 hours apart. Take it at the same time everyday.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • Take the missed dose as soon as you remember. If your next dose is less then 6 hours away, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
  • If you have only taken a part of your dose of the oral pellets, do not take another dose right away. Take your next dose at your regular dosing schedule, at least 12 hours after.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep this medicine in the original container (blister package or bottle for the capsules or aluminum bag for the packets of oral pellets). Do not store it in pill boxes or organizers.
• Open only 1 bottle of the capsule at a time. Use each bottle within 4 months after it is opened.
• Use each packet of oral pellets within 6 months of opening the aluminum bag. Throw away any unused medicine. Do not store and reuse any leftover mixture.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dabigatran works. Tell your doctor if you are also using dronedarone, ketoconazole, rifampin, NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen), or other blood thinners (including heparin, warfarin).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or planning to become pregnant, or if you have kidney disease, antiphospholipid syndrome, or a history of bleeding problems, stomach ulcers, spinal problems, or have had surgery on your spine.
• Do not breastfeed during treatment with this medicine.
• This medicine can cause you to bleed and bruise more easily. Take precautions to avoid injury. Brush and floss your teeth gently, do not play rough sports, and be careful with sharp objects. Severe bleeding can be life-threatening.
• Do not stop using this medicine without asking your doctor. Your risk of stroke is higher if you suddenly stop using this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Back pain, numbness, tingling, or weakness in your legs or feet, loss of bladder or bowel control
• Coughing up or vomiting blood or material that looks like coffee grounds
• Lightheadedness, dizziness, headache
• Red or black, tarry stools
• Red, brown, or pink urine
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Stomach pain, nausea, heartburn, indigestion

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088