When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to prasugrel or have a history of stroke.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Your doctor may tell you to take aspirin with this medicine.
• Do not break the tablet.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the tablets in the original container.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how prasugrel works. Tell your doctor if you are also using any of the following:
  
  • NSAID pain or arthritis medicine, such as aspirin, diclofenac, ibuprofen, naproxen, celecoxib
  • Blood thinner, such as warfarin
  • Other medicine to treat or prevent blood clots

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have any bleeding problems. Also tell your doctor if you have kidney disease, liver disease, or stomach ulcer, or if you are allergic to clopidogrel or ticlopidine.
• This medicine increases your risk of bleeding. Tell your doctor about all recent surgeries and injuries and if you have ever had bleeding in your stomach or intestines. Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• This medicine may cause thrombotic thrombocytopenic purpura (TTP), a serious blood clot problem.
• Do not stop taking this medicine without checking with your doctor first. Your risk for blood clots increases if you stop this medicine suddenly.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding that will not stop
• Blood in your urine or stools
• Change in how much or how often you urinate
• Chest pain
• Nosebleeds
• Pinpoint red or purple spots on the skin
• Trouble breathing, tiredness, fever, yellow skin or eyes, fast or pounding heartbeat, headache
• Unusual bleeding or bruising
• Vomiting of blood or material that looks like coffee grounds

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088