What is the most important information I should know about PRADAXA?

PRADAXA can cause bleeding which can be serious, and sometimes lead to death. This is because PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body.
You may have a higher risk of bleeding if you take PRADAXA and:
are over 75 years old
have kidney problems
have stomach or intestine bleeding that is recent or keeps coming back, or you have a stomach ulcer
take other medicines that increase your risk of bleeding, including: Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
aspirin or aspirin containing products
long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
warfarin sodium (Coumadin®, Jantoven®)
a medicine that contains heparin
clopidogrel (Plavix®)
prasugrel (Effient®)
PRADAXA can increase your risk of bleeding because it lessens the ability of your blood to clot. While you take PRADAXA:
Call your doctor or get medical help right away if you have any of these signs or symptoms of bleeding:
Take PRADAXA exactly as prescribed. Do not stop taking PRADAXA without first talking to the doctor who prescribes it for you. Stopping PRADAXA may increase your risk of a stroke.

PRADAXA may need to be stopped, if possible, for one or more days before any surgery, or medical or dental procedure. If you need to stop taking PRADAXA for any reason, talk to the doctor who prescribed PRADAXA for you to find out when you should stop taking it. Your doctor will tell you when to start taking PRADAXA again after your surgery or procedure.

See "What are the possible side effects of PRADAXA?" for more information about side effects.
you may bruise more easily
it may take longer for any bleeding to stop
What is PRADAXA?

PRADAXA is a prescription medicine used to reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to blood clots forming and increase your risk of a stroke. PRADAXA is a blood thinner medicine that lowers the chance of blood clots forming in your body.

It is not known if PRADAXA is safe and works in children.

Who should not take PRADAXA?

Do not take PRADAXA if you:

currently have certain types of abnormal bleeding. Talk to your doctor, before taking PRADAXA if you currently have unusual bleeding.
have had a serious allergic reaction to PRADAXA. Ask your doctor if you are not sure.
What should I tell my doctor before taking PRADAXA?

Before you take PRADAXA, tell your doctor if you:

have kidney problems
have ever had bleeding problems
have ever had stomach ulcers
have any other medical condition
are pregnant or plan to become pregnant. It is not known if PRADAXA will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into your breast milk.

Tell all of your doctors and dentists that you are taking PRADAXA. They should talk to the doctor who prescribed PRADAXA for you, before you have any surgery, or medical or dental procedure.

Tell your doctor ab