Dabigatran (By mouth)

Introduction

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

Prevents stroke and blood clots in patients who have atrial fibrillation. This medicine is a blood thinner.

Brand Name(s)

Pradaxa

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Swallow the capsules whole. Do not break, crush, or chew them. Do not open the capsules.
• Do not stop using this medicine without asking your doctor.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• If you take another medicine to thin your blood (such as heparin, warfarin, or Coumadin®), your doctor will give you very specific instructions about how to switch to dabigatran. Carefully follow the instructions and ask your doctor if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose. If you have less than 6 hours before your next scheduled dose, skip the missed dose and go back to your regular dosing schedule.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep your medicine in the original package (blister package or bottle) until you are ready to use it. Do not store the capsules in any other container (such as pill boxes or pill organizers). After you open a bottle for the first time, the capsules are good for only 4 months. If you have not used the capsules within 4 months, dispose of the remaining capsules and open a new bottle.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are also using dronedarone (Multaq®), ketoconazole (Nizoral®), rifampin (Rifadin®, Rimactane®), a blood thinner (such as clopidogrel, heparin, prasugrel, warfarin, Coumadin®, Effient®, Jantoven®, or Plavix®), or pain or arthritis medicine (NSAIDs such as aspirin, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Motrin®, Relafen®, or Voltaren®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease.
• You may bleed and bruise more easily while you use this medicine. Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when you use sharp objects, including razors and fingernail clippers. Blow your nose gently, and do not pick your nose.
• Check with your doctor right away if you have any unusual bruising or bleeding, including menstrual periods that are heavier than normal, frequent nosebleeds, or black or bloody urine or stools.
• Do not stop using this medicine suddenly without asking your doctor. You might have a higher risk of stroke for a short time right after you stop using this medicine.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

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
• Black, tarry stools
• Bruises that get larger or appear for no known reason
• Frequent nosebleeds, heavy vaginal bleeding, or other unusual bleeding
• Pink or brown urine
• Vomiting of blood or material that looks like coffee grounds
• Weakness, lightheadedness, dizziness, or fainting

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

• Nausea or vomiting
• Stomach upset or pain, heartburn, or 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