SARAFEM (fluoxetine hydrochloride tablets) is a selective serotonin reuptake inhibitor (SSRI) for oral administration.
Following is a list of all treatment-emergent adverse reactions reported at anytime by females and males taking fluoxetine in all US clinical trials for conditions other than PMDD as of May 8, 1995 (10,782 patients) except (1) those listed in the body or footnotes of Tables 1 or 5 above or elsewhere in labeling; (2) those for which the COSTART terms were uninformative or misleading; (3) those adverse reactions for which a causal relationship to fluoxetine use was considered remote; (4) adverse reactions occurring in only 1 patient treated with fluoxetine and which did not have a substantial probability of being acuy life-threatening; and (5) adverse reactions that could only occur in males.
Table 6 enumerates the most common treatment-emergent adverse reactions associated with the use of fluoxetine up to 80 mg (incidence of at least 2% for fluoxetine and greater than placebo) in female patients ages 18 to 45 years from US placebo-controlled clinical trials in the treatment of depression, OCD, and bulimia.
Systematic evaluation of SARAFEM has shown that its efficacy in PMDD is maintained for periods of up to 6 months at a dose of 20 mg/day given continuously and up to 3 months at a dose of 20 mg/day given intermittently.
Fluoxetine is used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder).
Do not store in the bathroom. Keep all medications away from children and pets. Store at room temperature away from light and moisture.
You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Call your doctor for medical advice about side effects.
If you have diabetes, fluoxetine may affect your blood sugar levels. Monitor your blood sugar regularly and share the results with your doctor. Your doctor may need to adjust your medication, diet, and exercise when you start or stop fluoxetine.
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Before using any medication, l your doctor or pharmacist if you have taken fluoxetine in the previous 5 weeks.
Physician reviewed Sarafem patient information - includes Sarafem description, dosage and directions.
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
You may report side effects to FDA at 1-800-FDA-1088. Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur.
upset stomach, loss of appetite, nausea, vomiting, diarrhea;
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
CSA Schedule N Not a controlled drug.
l your doctor right away if you become pregnant.
Easy to read patient leaflet for Sarafem. Includes indications, proper use, special instructions, precautions, and possible side effects.
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Ask your health care provider if Sarafem may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. This may not be a complete list of all interactions that may occur.
Ask your health care provider any questions you may have about how to use Sarafem.
To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Consumer information about the medication FLUOXETINE - ORAL (Prozac, Sarafem), includes side effects, drug interactions, recommended dosages, and.
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A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else.