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dabigatran (cont.)

What should I discuss with my healthcare provider before taking dabigatran (Pradaxa)?

You should not take dabigatran if you are allergic to it, or if you have any active bleeding from a surgery, injury, or other cause.

To make sure you can safely take dabigatran, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • a history of stomach ulcer or bleeding; or
  • if you are older than 75.

FDA pregnancy category C. It is not known whether dabigatran will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether dabigatran passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take dabigatran (Pradaxa)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Contact your doctor or seek emergency medical attention if you fall or hit your head, or have any bleeding that will not stop.

If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken dabigatran within the past 12 hours. You may need to stop taking dabigatran for a short time before you have surgery or other medical procedures.

Do not stop taking the medicine without first talking to your doctor.

Do not crush, chew, break, or open a dabigatran capsule. Swallow the pill whole.

Your kidney function may need to be checked with blood tests before and during treatment with dabigatran. Visit your doctor regularly.

Keep the capsules in their original container or blister pack. Do not put dabigatran capsules into a daily pill box or pill organizer.

If you have received more than a 30-day supply of this medication, do not open more than one bottle at a time. Open a new bottle only after all the capsules in the old bottle are gone.

Store at room temperature, away from moisture and heat. Keep each capsule in the bottle or blister pack until you are ready to take the medicine. Keep the bottle tightly closed when not in use.

Throw away any unused capsules if it has been longer than 4 months since you first opened the bottle. Capsules stored in a blister pack should be thrown away after the expiration date on the label has passed.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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