Brand Names: Prozac, Prozac Weekly, Rapiflux, Sarafem, Selfemra

Generic Name: fluoxetine (Pronunciation: floo OX e teen)

• What is fluoxetine (Sarafem)?
• What are the possible side effects of fluoxetine (Sarafem)?
• What is the most important information I should know about fluoxetine (Sarafem)?
• What should I discuss with my healthcare provider before taking fluoxetine (Sarafem)?
• How should I take fluoxetine (Sarafem)?
• What happens if I miss a dose (Sarafem)?
• What happens if I overdose (Sarafem)?
• What should I avoid while taking fluoxetine (Sarafem)?
• What other drugs will affect fluoxetine (Sarafem)?
• Where can I get more information?

What is fluoxetine (Sarafem)?

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 is sometimes used together with another medication called olanzapine (Zyprexa) to treat depression caused by bipolar disorder (manic depression). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Fluoxetine may also be used for other purposes not listed in this medication guide.

Fluoxetine 10 mg Cap-BAR

blue/yellow, imprinted with barr 10 mg, 876

Fluoxetine 10 mg Tab-BAR

oval, beige, imprinted with b, 201 10

Fluoxetine 10 mg Tab-TEV

oval, blue, imprinted with 9 3, 7188

Fluoxetine 10 mg-GEN

white, imprinted with GG 575

Fluoxetine 10 mg-IVA

turquoise/white, imprinted with Logo 4363, 10 mg

Fluoxetine 10 mg-MAL

green, imprinted with M 0661

Fluoxetine 10 mg-MYL

pink/white, imprinted with MYLAN 4210

Fluoxetine 10 mg-PAR

oval, white, imprinted with G, FL 10

Fluoxetine 10 mg-TEV

blue, imprinted with 93 42

Fluoxetine 20 mg Cap-BAR

blue/gray, imprinted with barr 20 mg, 877

Fluoxetine 20 mg-EON

green/white, imprinted with E85

Fluoxetine 20 mg-GEN

white, imprinted with GG 550

Fluoxetine 20 mg-IVA

turquoise, imprinted with Logo 4356, 20 mg

Fluoxetine 20 mg-MAL

green/white, imprinted with M inside a box 0663

Fluoxetine 20 mg-MYL

blue/pink, imprinted with MYLAN 4220

Fluoxetine 20 mg-PAR

oval, white, imprinted with G, FL 20

Fluoxetine 20 mg-TEV

blue/white, imprinted with 93 43

Fluoxetine 40 mg-IVA

blue, imprinted with Logo 4346, 40 mg

Fluoxetine 40 mg-MYL

blue/white, imprinted with MYLAN 4350

Fluoxetine 40 mg-PAR

white, imprinted with GG 540

Fluoxetine 40 mg-TEV

blue/orange, imprinted with 93 7198

Prozac 10 mg Tab

elliptical, green, imprinted with PROZAC 10

Prozac 10 mg

green, imprinted with DISTA 3104, PROZAC 10 mg

Prozac 20 mg

green/yellow, imprinted with DISTA 3105, PROZAC 20 mg

Prozac 40 mg

green/orange, imprinted with DISTA 3107, PROZAC 40mg

Selfemra 10 mg

blue, imprinted with 93 7225

Selfemra 20 mg

blue/pink, imprinted with 93 7226

What are the possible side effects of fluoxetine (Sarafem)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms 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.

Call your doctor at once if you have any of these serious side effects:

• severe blistering, peeling, and red skin rash;
• very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;
• nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
• headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• drowsiness, dizziness, feeling nervous;
• mild nausea, upset stomach, constipation;
• increased appetite, weight changes;
• sleep problems (insomnia);
• decreased sex drive, impotence, or difficulty having an orgasm; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluoxetine (Sarafem)?

Do not take fluoxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor.