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Prasugrel

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Warning

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.

Precautions

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.

Side Effects

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.