Prasugrel

IMPORTANT WARNING:

Prasugrel may cause serious or life-threatening bleeding. Tell your doctor if you have or have had a condition that causes you to bleed more easily than normal; bleeding in your stomach such as a stomach ulcer; bleeding in your intestines such as polyps (abnormal growths in the lining of the large intestine) or diverticulitis (inflamed bulges in the lining of the large intestine); a stroke or mini-stroke; or kidney or liver problems. Tell your doctor if you have recently had surgery or been injured in any way, if you may need to have heart bypass surgery (a certain type of open heart surgery), or if you weigh less than 132 lg (60 kg). Tell your doctor and pharmacist if you are taking drugs that may cause bleeding including blood thinners; other drugs to treat or prevent blood clots; or if you regularly take a nonsteroidal anti-inflammatory drug such as ibuprofen (Advil^®, Motrin^®), and naproxen (Aleve^®).

While you are taking prasugrel, you will probably bruise and bleed more easily than usual, bleed for longer than usual, and have nosebleeds. If you experience any of the following symptoms, call your doctor immediately: severe or uncontrolled bleeding; pink or brown urine; red or black, tarry stools; vomit that is bloody or that looks like coffee grounds; coughing up blood or blood clots; or bruises that are unexplained or that get larger.

If you are having surgery, including dental surgery, or any type of medical procedure, tell your doctor or dentist that you are taking prasugrel. Your doctor will probably tell you to stop taking prasugrel at least 7 days before your surgery is scheduled.

You will be given the Medication Guide when you begin treatment with prasugrel and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of taking prasugrel.

WHY is this medicine prescribed?

Prasugrel is used to prevent serious problems with heart and blood vessels in certain people who have had a heart attack or severe chest pain. Prasugrel is in a class of medications called anti-platelet medications. It works by preventing platelets (a type of blood cell) from collecting and forming clots that may cause a heart attack or stroke.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Prasugrel comes as a tablet to take by mouth. Take once a day with or without food. Take prasugrel at around the same time every day.

Take prasugrel exactly as directed. Ask your doctor or pharmacist to explain any part you do notunderstand. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablet whole; do not split, break, chew, or crush it.

You will probably need to take aspirin during your treatment with prasugrel.

Prasugrel will help prevent serious problems with your heart and blood vessels only as long as you take the medication. Do not stop taking prasugrel without talking to your doctor. If you stop taking prasugrel, there is a higher risk that you may have a heart attack, develop a blood clot, or die.

What SPECIAL PRECAUTIONS should I follow?

Before taking prasugrel,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, food, or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking prasugrel. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking prasugrel, call your doctor.

• this medication may not be recommended in people 75 year or older. There may be other treatment options that are safer or work better. Talk to your doctor about the risks and benefits of taking this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Prasugrel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• excessive tiredness
• pain in the back, arms, or legs
• cough
• swelling of the arms, hands, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• fever; weakness; paleness; purple patches on the skin; yellowing of the skin or eyes; shortness of breath; slow, fast, or irregular heartbeat;
• sudden headache, confusion, seizures, slow or difficult speech, or sudden weakness or numbness of an arm or leg
• stomach pain, nausea, vomiting, or diarrhea
• decreased urination or red or pink urine
• rash; swelling of the eyes, face, mouth, lips, tongue, throat; diffuluty breathing or swallowing; chest pain or pressure; or dizziness or fainting

Prasugrel may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. The medication will come with a gray cylinder that helps keep the tablets dry; leave this cylinder in the container with the medication. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reachhttps://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.