Sarafem (Fluoxetine)

Drug Uses

This medicine is a selective serotonin reuptake inhibitor (SSRI) used to treat premenstrual dysphoric disorder (PMDD). It may also be used to treat other conditions as determined by your doctor.

How Taken

Take this medication by mouth usually once a day in the morning, with or without food, or as directed by your doctor. If your doctor tells you to take this medication twice a day, take a dose in the morning and at noon.

Dosage is based on your medical condition and response to therapy. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Do not take more or less medication than prescribed.

The maximum recommended dose for adults treated for obsessive-compulsive disorder and premenstrual dysphoric disorder is 80 mg per day. The maximum recommended dose for children with attention-deficit hyperactivity disorder (ADHD) treated for depression is 20 mg per day. It may take 4 weeks or longer before the full benefit of this drug takes effect. Inform your doctor if your condition persists or worsens.

Drug Class and Mechanism

Sarafem is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, obsessive-compulsive disorder, panic attacks, certain eating disorders (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder or PMDD). This medication works by restoring the balance of natural substances (neurotransmitters) in the brain, thereby improving mood and feelings of well-being.

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 at room temperature between 59-86 degrees F (15-30 degrees C), away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Warnings/Precautions

Before taking sarafem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, stomach bleeding, diabetes, seizure disorder.

Though uncommon, depression can lead to thoughts or attempts of suicide. Tell your doctor immediately if you have any suicidal thoughts, worsening depression, or any other mental/mood changes (including new or worsening anxiety, agitation, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, rapid speech).

Keep all medical appointments so your healthcare professional can monitor your progress closely and adjust/change your medication if needed. If you have diabetes, sarafem may affect your blood glucose levels. Monitor your blood glucose regularly, and share the results with your doctor. The dose of your anti-diabetic medication(s) may need to be adjusted.

Liquid preparations of this product may contain sugar and/or small amounts of alcohol. Ask your doctor or pharmacist about the safe use of this product if you have diabetes. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially drowsiness.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. If this medication is used during the last 3 months of pregnancy, infrequently your newborn may develop symptoms including feeding or breathing difficulties, seizures, muscle stiffness, jitteriness or constant crying.

However, do not stop taking this medication unless your doctor directs you to do so. Report any such symptoms to your doctor promptly. Sarafem passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while taking this drug is not recommended. Consult your doctor before breast-feeding.

Possible Side Effects

Nausea, loss of appetite, diarrhea, dry mouth, trouble sleeping, dizziness, drowsiness, yawning, weakness, or sweating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Tell your doctor immediately if any of these serious side effects occur:

• unusual or severe mental/mood changes (e.g., anxiety, mania),
• weight loss,
• change in sexual desire and ability,
• vision changes.

Tell your doctor immediately if any of these unlikely but serious side effects occur: uncontrolled movements (tremor), fever/flu-like symptoms.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur:

• unusual muscle stiffness,
• fast/irregular heartbeats,
• chest pain,
• black stools,
• vomit that looks like coffee grounds,
• easy bruising/bleeding,
• unusual bleeding,
• seizures.

For males, in the very unlikely event you have a painful, prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention or permanent problems could occur. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs.

Symptoms of a serious allergic reaction include:

• rash,
• itching,
• swelling,
• severe dizziness,
• trouble breathing.

If you notice other effects not listed above, contact your doctor or pharmacist.

More Information

Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions.

Keep this medicine out of the reach of children. If using this medicine for an extended period of time, obtain refills before your supply runs out.