Dabigatran etexilate Oral capsule

What is this medicine?

DABIGATRAN (DA bi GAT ran) is an anticoagulant (blood thinner). It is used to lower the chance of stroke in people with a medical condition called atrial fibrillation. It is also used to treat or prevent blood clots in the lungs or in the veins.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders

• history of stomach bleeding

• mechanical heart valve

• kidney disease

• recent or planned spinal or epidural procedure

• an allergic reaction to dabigatran, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Swallow the capsules whole. Do not break, chew, or empty the contents from the capsule. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. Stopping this medicine may increase your risk of a blot clot. Be sure to refill your prescription before you run out of medicine.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is less than 6 hours away, skip the missed dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

• mifepristone, RU-486

This medicine may also interact with the following:

• carbamazepine

• certain medicines for depression

• dronedarone

• ketoconazole

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• quinidine

• rifampin

• tipranavir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups.

Notify your doctor or health care professional and seek emergency treatment if you develop breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm, or leg. These can be signs that your condition has gotten worse.

If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.

Tell your health care professional that you use this medicine before you have a spinal or epidural procedure. Sometimes people who take this medicine have bleeding problems around the spine when they have a spinal or epidural procedure. This bleeding is very rare. If you have a spinal or epidural procedure while on this medicine, call your health care professional immediately if you have back pain, numbness or tingling (especially in your legs and feet), muscle weakness, paralysis, or loss of bladder or bowel control.

Avoid sports and activities that might cause injury while you are using this medicine. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• feeling faint or lightheaded, falls

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• stomach pain

• upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep capsules in the original container. Do not store or place capsules in any other container, such as pill boxes or pill organizers. After opening the bottle, use within 4 months. Throw away any unused medicine after 4 months.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.