SARAFEM 10, 20 MG

IMPORTANT SARAFEM NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using Sarafem.

FLUOXETINE - ORAL (flew-OX-eh-teen)

COMMON SARAFEM BRAND NAME(S): Prozac, Sarafem

SARAFEM USES: Fluoxetine is used to treat depression, bulimia (an eating disorder), obsessive compulsive disorders (OCD), and severe symptoms of premenstrual syndrome (premenstrual dysphoric disorder-PMDD). Sarafem works by helping to restore the balance of certain natural chemicals in the brain.

OTHER SARAFEM USES: Sarafem has also been used to treat panic attacks, obesity, and alcoholism.

HOW TO USE SARAFEM: Take Sarafem by mouth usually once daily in the morning, with or without food; or as directed by your doctor. The dosage is based on your medical condition and response to therapy. Some medical conditions may require a different dosing schedule (e.g., twice daily in the morning and at noon) as determined by your doctor. Take Sarafem exactly as prescribed. It is important to continue taking Sarafem even if you feel well. Also, do not stop taking Sarafem without consulting your doctor. It may take up to 4 weeks before the full benefit of Sarafem takes effect.

SARAFEM SIDE EFFECTS: Nausea, headache, trouble sleeping, dry mouth, drowsiness, sweating, or upset stomach may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: loss of appetite, unusual weight loss, unusual or severe mental/mood changes, uncontrolled movements (tremor), decreased interest in sex, flu-like symptoms (e.g., chills, fever, muscle aches, weakness). Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, trouble swallowing, swelling or white spots on the mouth and/or tongue, changes in sexual ability, painful and/or prolonged erection. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: fainting, irregular/fast heartbeat. An allergic reaction to Sarafem is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects from Sarafem not listed above, contact your doctor or pharmacist.

SARAFEM PRECAUTIONS: Tell your doctor your medical history, especially of: liver problems, kidney disease, seizures, heart problems, diabetes, any allergies. Sarafem may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Liquid preparations of Sarafem may contain sugar and/or small amounts of alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about the safe use of Sarafem. Caution is advised when using Sarafem in the elderly because they may be more sensitive to the effects of the drug. Sarafem should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Sarafem passes into breast milk. Because of the potential risk to the infant, breast-feeding while using Sarafem is not recommended. Consult your doctor before breast-feeding.

SARAFEM DRUG INTERACTIONS: Certain medications taken with Sarafem could result in serious, even fatal, drug interactions. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks, and avoid taking thioridazine within 5 weeks, before or after treatment with Sarafem. Consult your doctor or pharmacist for additional information. Sarafem is not recommended for use with: weight loss medicine (e.g., sibutramine, phentermine), thioridazine, terfenadine, astemizole. Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially: other SSRI antidepressants (e.g., citalopram, sertraline), nefazodone, trazodone, venlafaxine, "triptan" migraine drugs (e.g., sumatriptan, zolmitriptan), tramadol, tricyclic antidepressants (e.g., amitriptyline, nortriptyline), flecainide, propafenone, haloperidol, clozapine, lithium, tryptophan, "blood thinners" (e.g., warfarin), anti-seizure drugs (e.g., carbamazepine, phenytoin/hydantoins), herbal/natural products (e.g., St John's wort, ayahuasca). Tell your doctor if you take any drugs that cause drowsiness such as: medicine for sleep, tranquilizers, anti-anxiety drugs (e.g., alprazolam), narcotic pain relievers (e.g., codeine), muscle relaxants, psychiatric medicine (e.g., phenothiazines such as chlorpromazine), certain antihistamines (e.g., diphenhydramine). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of these products. Report other drugs which affect the heart rhythm (QTc prolongation), such as: dofetilide, pimozide, sotalol, quinidine, procainamide, sparfloxacin, "water pills" (diuretics such as furosemide or hydrochlorothiazide). Ask your doctor or pharmacist for more details. Fluoxetine may affect the amount of glucose (sugar) in your blood. If you take any anti-diabetes medication (e.g., glipizide, glyburide, metformin), your dosage of these drugs may need to be adjusted when fluoxetine (Sarafem) is started or discontinued. Consult your doctor. Do not start or stop Sarafem or any medicine without doctor or pharmacist approval.

SARAFEM OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: irregular heartbeat, fainting, severe dizziness or lightheadedness.

SARAFEM NOTES: Do not share Sarafem with others. Laboratory and/or medical tests may be performed to monitor your progress.

MISSED SARAFEM DOSE: If you miss a Sarafem dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed Sarafem dose and resume your usual dosing schedule. Do not double the Sarafem dose to catch up.

SARAFEM STORAGE: Store Sarafem at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.