Prasugrel Oral tablet

What is this medicine?

PRASUGREL (PRA soo grel) helps to prevent blood clots. This medicine is used to prevent heart attack, stroke, or other vascular events in people who are at high risk.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders

• kidney disease

• liver disease

• recent trauma or surgery

• stomach or intestinal ulcers

• stroke or transient ischemic attack

• an unusual or allergic reaction to prasugrel, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a drink of water. Follow the directions on the prescription label. You may take this medicine with or without food. If it upsets your stomach, take it with food. This medicine may be chewed or it may be crushed and put into food or liquids such as applesauce, juice, or water as long as it is taken immediately. This medicine has a bitter taste that you may notice if it is chewed or crushed. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• aspirin

• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Do not stop taking your medicine unless your doctor tells you to.

Notify your doctor or health care professional and seek emergency treatment if you develop breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm, or leg. These can be signs that your condition has gotten worse.

If you are going to have surgery or dental work, tell your doctor or health care professional that you are taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• headache

• nausea, vomiting

• pain in back, arms or legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep this medicine in the original container. Keep container closed and do not remove the gray cylinder from the bottle. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.