PRADAXA SAFETY INFORMATION

PRADAXA can cause bleeding, which can be serious and sometimes lead to death. This is because PRADAXA is a blood-thinning medicine (anticoagulant) that lowers the chance of blood clots forming in your body. To find the best dose of PRADAXA for you, your doctor should test your kidney function before you take your first dose of PRADAXA, and in some instances yearly there after. Click on the links below to learn more about who should not take PRADAXA, what conditions may increase your risk of bleeding, and when to call your doctor or seek emergency treatment.

You may have a higher risk of bleeding if you take PRADAXA and:

• Are 75 years old or older.
• 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:
  • – 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^®).
• Have certain kidney problems and also take the medicines dronedarone (Multaq^®) or ketoconazole tablets (Nizoral^®)

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.

PRADAXA can increase your risk of bleeding because it lessens the ability of your blood to clot. While you take PRADAXA:

• You may bruise more easily.
• It may take longer for any bleeding to stop.

Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:

• Any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time.
• Unusual or unexpected bruising.
• Coughing up or vomiting blood; or vomit that looks like coffee grounds.
• Pink or brown urine; red or black stools (looks like tar).
• Unexpected pain, swelling, or joint pain.
• Headaches and feeling dizzy or weak.

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 check if they want you to stop, and when you should stop taking it if they do. Your doctor will tell you when to start taking PRADAXA again after your surgery or procedure.

PRADAXA is a prescription medicine used to reduce the risk of stroke and blood clots in people who have an irregular heartbeat called atrial fibrillation (or AFib) that’s not caused by a heart valve problem. 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 an anticoagulant that lowers the chance of blood clots forming in your body.

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

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. Click on the “WHAT ARE THE INGREDIENTS IN PRADAXA?” question in the list below to find out the ingredients in this medicine.

Only your doctor can decide if PRADAXA may be appropriate for you.

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 baby.
• Are breastfeeding or plan to breastfeed. It is not known if PRADAXA passes into 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/dental procedure.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way PRADAXA works. Certain medicines may increase your risk of bleeding. Click on the “WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PRADAXA?” link above to learn more.

Especially tell your doctor if you take:

• rifampin (Rifater, Rifamate, Rimactane, Rifadin).

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

• Take PRADAXA exactly as prescribed by your doctor.
• Do not take PRADAXA more often than your doctor tells you to.
• You can take PRADAXA with or without food.
• PRADAXA comes in a bottle or in a blister package.
• Only open 1 bottle at a time. Finish your opened bottle of PRADAXA before opening a new bottle.
• After opening a bottle of PRADAXA, use within 4 months.
• When it is time for you to take a dose of PRADAXA, only remove your prescribed dose of PRADAXA from your open bottle or blister package.
• Tightly close your bottle of PRADAXA right away after you take your dose.
• Swallow PRADAXA capsules whole. Do not break, chew, or empty the pellets from the capsule.
• If you miss a dose of PRADAXA, take it as soon as you remember. If your next dose is less than 6 hours away, skip the missed dose. Do not take two doses of PRADAXA at the same time.
• Your doctor will decide how long you should take PRADAXA. Do not stop taking PRADAXA without first talking with your doctor. Stopping PRADAXA may increase your risk of stroke.
• Do not run out of PRADAXA. Refill your prescription before you run out. If you plan to have surgery, or a medical or dental procedure, tell your doctor and dentist that you are taking PRADAXA. You may have to stop taking PRADAXA for a short time.
• If you take too much PRADAXA, go to the nearest hospital emergency room or call your doctor.
• Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you.

PRADAXA can cause serious side effects. Click on the “WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PRADAXA?” link above to learn more.

In some people, PRADAXA can cause symptoms of an allergic reaction, including hives, rash, and itching. Tell your doctor or get medical help right away if you get any of the following symptoms of a serious allergic reaction with PRADAXA:

• Chest pain or chest tightness.
• Swelling of your face or tongue.
• Trouble breathing or wheezing.
• Feeling dizzy or faint.

Common side effects of PRADAXA include:

• Indigestion, upset stomach, or burning.
• Stomach pain.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of PRADAXA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088, or by visiting www.fda.gov/medwatch.

Active ingredient: dabigatran etexilate mesylate

Inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, FD&C Blue No. 2 (150 mg strength only), FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink.