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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

• if you are older than 75.

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

It is not known whether dabigatran passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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