Dabigatran

Dabigatran is used to help prevent strokes or serious blood clots in people who have atrial fibrillation (condition in the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes). Dabigatran is in a class of anticoagulant ('blood thinner') medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.

Dabigatran comes as a capsule to take by mouth. It is usually taken with or without food twice a day. Take dabigatran at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dabigatran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the capsules whole; do not split, chew, or crush them. Do not open the capsules and sprinkle the contents on food or into drinks. Dabigatran will help prevent strokes and blood clots only as long as you continue to take it. Continue to take dabigatran even if you feel well. Make sure to refill your prescription before you run out of medication so that you will not miss doses of dabigatran. Do not stop taking dabigatran without talking to your doctor. If you suddenly stop taking dabigatran, the risk that you will have a stroke may increase. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dabigatran and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (<a href='http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm'>http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm</a>) or the manufacturer's website to obtain the Medication Guide.

<p></p> <p></p> <p></p> <p>Dabigatran may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

<ul>
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stomach pain</li>
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heartburn</li>
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nausea</li></ul></p> <p></p> <p>Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

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unusual bruising or bleeding</li>
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pink or brown urine</li>
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red or black, tarry stools</li>
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coughing up blood</li>
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vomiting material that is bloody or looks like coffee grounds</li>
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bleeding from the gums</li>
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frequent nosebleeds</li>
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heavy menstrual bleeding</li>
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bleeding from a cut that lasts longer than normal</li>
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joint pain or swelling</li>
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headache</li>
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dizziness</li>
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weakness</li>
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hives</li>
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rash</li>
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itching</li>
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difficulty breathing or swallowing</li>
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swelling of the arms, hands, feet, ankles, or lower legs</li></ul>Dabigatran may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at <a href='http://www.fda.gov/Safety/MedWatch'>http://www.fda.gov/Safety/MedWatch</a>] or by phone [1-800-332-1088].</p>

Before taking dabigatran, tell your doctor and pharmacist if you are allergic to dabigatran, any other medications, or any of the ingredients in dabigatran capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: other anticoagulants ('blood thinners') such as warfarin (Coumadin), aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve), clopidogrel (Plavix), heparin, prasugrel (Effient), and rifampin (Rifadin, Rimactane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have recently noticed any unusual bruising or bleeding. Your doctor may tell you not to take dabigatran. tell your doctor if you are 75 years of age or older and if you have or have ever had a bleeding problem, bleeding or an ulcer in your stomach or intestine, or kidney disease. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dabigatran.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. Symptoms of overdose may include the following:

<ul>
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unusual bruising or bleeding</li>
<li>
pink or brown urine</li>
<li>
red or black, tarry stools</li>
<li>
vomiting material that is bloody or looks like coffee grounds</li>
<li>
coughing up blood</li></ul>