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Patients should be advised that hyponatremia has been reported as a result of treatment with SNRIs and SSRIsincluding SARAFEMSigns and symptoms of hyponatremia include headachedifficulty concentratingmemory impairmentconfusionweaknessand unsteadinesswhich may lead to fallsMore severe and/or acute cases have been associated with hallucinationsyncopeseizurecomarespiratory arrestand deathsee WARNINGS AND PRECAUTIONS

Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy.

Tell your doctor right away if any of these unlikely but serious side effects occurunusual or severe mental/mood changessuch as agitationunusual high energy/excitementthoughts of suicideeasy bruising/bleedingmuscle weakness/spasmshakinesstremordecreased interest in sexchanges in sexual abilityunusual weight loss.

A lower or less Frequent dosage should be used in patients with hepatic impairmentsee CLINICAL PHARMACOLOGY and Use in Specific Populations

During pregnancythis medication should be used only when clearly neededIt may harm an unborn babyAlsobabies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficultiesseizuresmuscle stiffnessor constant cryingIf you notice any of these symptoms in your newborntell the doctor promptly.

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