Prasugrel oral tablets

What is this medication?

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.

COMMON BRAND NAME(S): Effient

What should I tell my care team before I take this medication?

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

• Bleeding disorders
• Bleeding in the brain
• Colon polyps
• Diverticulitis
• Kidney disease
• Liver disease
• Recent trauma or surgery
• Stomach bleeding
• Stomach ulcers, other stomach or intestine problems
• Stroke or transient ischemic attack
• An unusual or allergic reaction to prasugrel, other medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not crush, cut, or chew the tablet. Swallow the tablets whole.

You may take this medication with or without food. If it upsets your stomach, take it with food.

Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication 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 medication?

Do not take this medication with any of the following:

• Defibrotide

This medication may also interact with the following:

• Certain medications that treat or prevent blood clots, such as warfarin
• Opioid medications for pain
• NSAIDS, medications for pain and inflammation, such as 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 medication?

Visit your care team for regular checks on your progress. Keep taking your medication unless your care team tells you to stop.

This medication can cause a blood clotting problem called thrombotic thrombocytopenic purpura (TTP). TTP is a rare but serious medical condition that can be deadly. Get medical help right away if you have purple spots on your skin or inside your mouth, pale skin, yellowing skin or eyes, unusual weakness or fatigue, fever, fast or irregular heartbeat, confusion, change in vision, trouble speaking, or trouble walking.

If you are going to need surgery, dental work, or other procedure, tell your care team that you are using this medication.

If you get black, tarry stools or vomit up what looks like coffee grounds, call your care team right away. You may have a bleeding ulcer.

What side effects may I notice from receiving this medication?

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
• bleeding (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)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• kidney injury (trouble passing urine or change in the amount of urine)
• purple spots on your skin or mouth
• stomach pain
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• unusually weak or tired
• yellowing of the eyes or skin

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 medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry.

Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.