Effient (prasugrel) helps to prevent platelets in your blood from sticking together and forming a blood clot. An unwanted blood clot can occur with certain heart or blood vessel conditions.

Effient is used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack.

Effient may also be used for other purposes not listed in this medication guide.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking prasugrel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once a day. Your doctor may direct you to take this medication with low-dose aspirin (usually at dosages of 81-325 milligrams a day). Follow your doctor's instructions carefully.

The manufacturer directs not to split the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split. Follow your doctor's directions on how to take this medication.

It is very important to take prasugrel exactly as directed. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Also, do not stop using this medication unless directed by your doctor.

The dosage is based on your medical condition, weight, and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

You should not take Effient if you have active bleeding such as a stomach ulcer or bleeding in the brain, if you have ever had a stroke or "mini-stroke", or if you are scheduled to have surgery, especially heart bypass surgery.

Effient increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop, if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds.

You may need to stop using the medicine for a short time before any surgery or dental treatment. Do not stop taking Effient unless your doctor tells you to.

While you are taking Effient, do not take NSAIDs (non-steroidal anti-inflammatory drugs) without your doctor's advice. NSAIDs include ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.

You should not use Effient if you are allergic to prasugrel, or if you have:

• any active bleeding such as a stomach ulcer or bleeding in the brain (such as from a head injury);
• a history of stroke, including TIA ("mini-stroke"); or
• if you are scheduled to have surgery, especially heart bypass surgery (coronary artery bypass graft, or CABG).

To make sure Effient is safe for you, tell your doctor if you have:

• a stomach ulcer;
• bleeding problems;
• surgery, an injury, or a medical emergency;
• liver or kidney disease;
• a severe allergic reaction to clopidogrel (Plavix) or ticlopidine (Ticlid); o
• if you weigh less than 132 pounds; or
• if you also use other medicines to treat or prevent blood clots.

Aspirin is usually given with Effient, and aspirin can cause bleeding when taken during the last 3 months of pregnancy. Aspirin can also cause side effects in a newborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

You should not breast-feed while using this medicine.

Headache, nausea, nosebleed, and stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause serious bleeding. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, coughing up blood, bloody/black/tarry stools, bloody urine, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, shortness of breath, chest pain, difficulty swallowing.

Prasugrel has rarely caused a certain blood disorder (thrombotic thrombocytopenic purpura). Get medical help right away if you develop symptoms of this blood disorder, including: vision changes, slurred speech, confusion, yellowing eyes/skin, dark urine, signs of kidney problems (such as change in the amount of urine), unusual weakness/tiredness, unexplained fever.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: severe rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

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. Do not crush, cut, or chew the tablet. If you are not able to take the tablet whole, talk to your prescriber about other ways to take this medicine. 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.

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?

Do not take this medicine with any of the following medications:

• defibrotide
• his medicine may also interact with the following medications:
• certain medicines that treat or prevent blood clots like warfarin
• narcotic medicines for pain
• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen

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.