IMPORTANT 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 this drug.

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

COMMON BRAND NAME(S): Prozac, Sarafem

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

FLUOXETINE: is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms. Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD). Fluoxetine may also be used for purposes other than those listed in this medication guide.

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

Take Fluoxetine 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 this medication exactly as prescribed. It is important to continue taking this medication even if you feel well. Also, do not stop taking this medication without consulting your doctor. It may take up to 4 weeks before the full benefit of this drug takes effect.

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 this drug 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 not listed above, contact your doctor or pharmacist.

OTHER INFORMATION: You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk. While you are taking fluoxetine you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment. Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), thoughts of suicide or hurting yourself. Do not take Prozac together with thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine (Mellaril).
 
PRECAUTIONS: Tell your doctor your medical history, especially of: liver problems, kidney disease, seizures, heart problems, diabetes, any allergies. This drug 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 this product 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 this product. Caution is advised when using this product in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Certain medications taken with Prozac 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 this medication. Consult your doctor or pharmacist for additional information. This drug 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 is started or discontinued. Consult your doctor. Do not start or stop any medicine without doctor or pharmacist approval.

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

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

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

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