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What should my health care professional know before I take Pradaxa?

You should not take dabigatran if you are allergic to it, or if you have:

• an artificial heart valve; or

• any active bleeding from a surgery, injury, or other cause.

Dabigatran may cause you to bleed more easily, especially if:

• you have a stomach ulcer;

• you have recent or recurring bleeding in your stomach or intestines;

• you have kidney disease (especially if you also take dronedarone or ketoconazole);

• you take certain other medicines that can increase bleeding risk, such as aspirin, clopidogrel (Plavix), heparin, prasugrel, warfarin (Coumadin, Jantoven);

• you take an NSAID (nonsteroidal anti-inflammatory drug) on a regular basis, such as ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or

• you are older than 75.

Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:

• you have a genetic spinal defect;

• you have a spinal catheter in place;

• you have a history of spinal surgery or repeated spinal taps;

• you have recently had a spinal tap or epidural anesthesia;

• you are taking an NSAID--Advil, Aleve, Motrin, and others; or

• you are using other medicines to treat or prevent blood clots.

To make sure dabigatran is safe for you, tell your doctor if you have:

• kidney disease;

• a history of stomach ulcer or bleeding; or

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It is not known whether Pradaxa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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