Risks and Possible Side Effects
Prescribing Information and Medication Guide

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TREXIMET tablets contain 85 mg sumatriptan and 500 mg naproxen sodium.

Ask your doctor if TREXIMET is right for you.

Prescription TREXIMET is for the acute treatment of migraine attacks in adults.

Please Read Important Safety Information about TREXIMET

TREXIMET may increase the risk of heart attack, stroke, serious stomach and intestinal problems such as bleeding and ulcers, and serious rash that may be fatal and occur without warning. Risk of stomach and intestinal problems increases in the elderly.

Do not take TREXIMET if you have a history of heart or liver disease, stroke, TIAs, problems with blood circulation, uncontrolled blood pressure, or allergic reaction to aspirin, NSAIDs, or sumatriptan (Imitrex®); or right before or after heart surgery called coronary artery bypass graft (CABG).

Talk to your doctor before taking TREXIMET if you have risk factors for heart disease like high blood pressure, high cholesterol, smoking, obesity, diabetes, family history of heart disease, are a post-menopausal female, or male over age 40.

Talk to your doctor before taking TREXIMET if you have stomach ulcers or bleeding; chest pain, shortness of breath, irregular heartbeats; kidney problems; are pregnant, nursing, or thinking about becoming pregnant; or taking medications, especially pain relievers or antidepressants. Serotonin syndrome, a life-threatening problem, may occur with TREXIMET, especially if used with antidepressants called SSRIs or SNRIs. Do not take TREXIMET if you have taken an MAOI antidepressant within the last 2 weeks. TREXIMET should only be used exactly as prescribed, at the lowest dose and for the shortest time possible.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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