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It is important to continue taking this medication as prescribed even if you feel wellDo not stop taking this medication without first consulting your doctorSome conditions may become worse when the drug is abruptly stoppedYour dose may need to be gradually decreased.

Families and caregivers of patients being treated with antidepressants for Major Depressive Disorder or other indicationsboth psychiatric and nonpsychiatricshould be alerted about the need to monitor patients for the emergence of agitationirritabilityunusual changes in behaviorand the other symptoms described aboveas well as the emergence of suicidalityand to report such symptoms immediately to health care providersSuch monitoring should include daily observation by families and caregiversPrescriptions for SARAFEM should be written for the smallest quantity of tablets consistent with good patient managementin order to reduce the risk of overdose.

Fluoxetine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart diseasePatients with these diagnoses were systematically excluded from clinical studies during the product’s premarket testingHoweverthe electrocardiograms of 312 patients who received fluoxetine in double-blind trialsfor a condition other than PMDDwere retrospectively evaluatedno conduction abnormalities that resulted in heart block were observedThe mean heart rate was reduced by approximately 3 beats/min.

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