Effient 5 mg tablet

Generic name:
Prasugrel - oral

Pronunciation
(PRA-soo-grel)

Brand name(s)
Effient

Prasugrel can rarely cause very serious (possibly fatal) bleeding. Tell your doctor right away if you notice any signs of serious bleeding. See also Side Effects and Precautions sections.

Prasugrel is used with aspirin by patients with heart disease (recent heart attack, unstable angina) who undergo a certain heart procedure (angioplasty). This medication helps to prevent other serious heart/blood vessel problems (such as heart attacks, strokes, blood clots in stents). It works by blocking platelets from sticking together and prevents them from forming harmful blood clots. This "anti-platelet" effect helps to keep blood flowing smoothly in your body.

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 81-162 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.

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

Remember that this medication has been prescribed because your doctor 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:

• nosebleeds that happen often or don't stop
• unusual pain/swelling/discomfort
• unusual bruising
• prolonged bleeding from cuts or gums
• 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
• trouble speaking
• 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking prasugrel, tell your doctor or pharmacist if you are allergic to it; or to similar antiplatelet drugs (thienopyridines such as clopidogrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood disorders (such as hemophilia)
• bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain)
• blood clots in the brain (stroke, transient ischemic attack-TIA)
• recent major injury/surgery
• liver disease
• stomach/intestinal ulcers

Before having surgery or any medical/dental procedures (including heart bypass surgery-CABG), tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.

Older adults (75 years or older) may be more sensitive to the side effects of this drug, especially bleeding. Discuss the risks and benefits with your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• tipranavir

This medication is sometimes used together with other drugs that have "blood thinning" or anti-platelet effects, such as aspirin or heparin. When these combinations are prescribed by your doctor, you will require closer monitoring to minimize your risk of bleeding. Keep all medical and lab appointments.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen, naproxen) that may increase your risk for bleeding if taken together with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original bottle at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Tightly close the bottle when not in use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.