Naproxen and Sumatriptan Tablets

Use only if a clear diagnosis of migraine headache has been established. If a
patient has no response to the first migraine attack treated with Naproxen and
Sumatriptan Tablets 500 mg/85 mg, reconsider the diagnosis of migraine before
Naproxen and Sumatriptan Tablets 500 mg/85 mg is administered to treat any
subsequent attacks.
Naproxen and Sumatriptan Tablets 500 mg/85 mg is not indicated for the
prevention of migraine attacks.
Safety and effectiveness of Naproxen and Sumatriptan Tablets 500 mg/85 mg
have not been established for cluster headache.

Adults
The recommended dosage for adults is 1 tablet of Naproxen and Sumatriptan Tablets 500 mg/85 mg. Naproxen and Sumatriptan Tablets 500 mg/85 mg contains a dose of sumatriptan higher than the lowest effective dose. The choice of the dose of sumatriptan, and of the use of a fixed combination such as in Naproxen and Sumatriptan Tablets 500 mg/85 mg should be made on an individual basis, weighing the possible benefit of a higher dose of sumatriptan with the potential for a greater risk of adverse reactions. The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart. The safety of treating an average of more than 5 migraine headaches in adults in a 30-day period has not been established.

The following serious adverse reactions are described below:
Cardiovascular Thrombotic Events
GI Bleeding, Ulceration and Perforation
Arrhythmias
Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure
Cerebrovascular Events
Other Vasospasm Reactions
Hepatotoxicity
Hypertension
Heart Failure and Edema
Medication Overuse Headache
Serotonin Syndrome
Renal Toxicity and Hyperkalemia
Anaphylactic Reactions
Serious Skin Reactions
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Hematological Toxicity
Exacerbation Asthma Related to Aspirin Sensitivity

Cardiovascular Thrombotic Events
The use of Naproxen and Sumatriptan Tablets 500 mg/85 mg is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD) and in the setting of coronary artery bypass graft (CABG) surgery due to increased risk of serious cardiovascular events with sumatriptan and NSAIDS.
Cardiovascular Events with Sumatriptan: There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. Naproxen and Sumatriptan Tablets 500 mg/85 mg may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.
Cardiovascular Thrombotic Events with Nonsteroidal Anti-inflammatory Drugs: Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs, including naproxen, a component of Naproxen and Sumatriptan Tablets 500 mg/85 mg, cause serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal.
Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure
Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan and are usually non-cardiac in origin. The use of Naproxen and Sumatriptan Tablets 500 mg/85 mg is contraindicated in patients with CAD and those with Prinzmetal’s variant angina.
Hypertension
Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including sumatriptan, a component of Naproxen and Sumatriptan Tablets 500 mg/85 mg. NSAIDs, including naproxen, a component of Naproxen and Sumatriptan Tablets 500 mg/85 mg, can also lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events.

Store below 30°C. Protect from light and moisture.
Keep the medicine out of reach of children.

10 × 1 × 10 Alu/PVC Blister.
S-MEPROX tablets are available in an Alu/PVC blister of 10 tablets. Such 1 blister in a monocarton and Such 10 monocartons in a unit carton with pack insert.