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Product description Safety information Side Effects

Drug Name

Sarafem (Fluoxetine)

Drug Uses

Sarafem is used for treating premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome. It may also be used for other conditions as determined by your doctor.

How to use

Use Sarafem as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Sarafem comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sarafem refilled.
Take Sarafem by mouth with or without food.
Taking Sarafem at the same time each day will help you remember to take it.
Continue to take Sarafem even if you feel well. Do not miss any doses.
Do not suddenly stop taking Sarafem without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Sarafem and whenever a change in dose is made.

Drug Class and Mechanism

Sarafem is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of serotonin, a natural substance in the brain, which helps to improve mood.

Missed Dose

If you miss a dose of Sarafem, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Do NOT use Sarafem if:

• you are allergic to any ingredient in Sarafem
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days
• you are taking a fenfluramine derivative (eg, dexfenfluramine), an H1 antagonist (eg, astemizole, terfenadine), nefazodone, pimozide, a serotonin norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), sibutramine, thioridazine, or tryptophan

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Sarafem . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
• if you have a history of seizures, heart problems, liver problems, severe kidney problems, stomach or bowel bleeding, diabetes, or metabolism problems
• if you are dehydrated, have low blood sodium levels, or drink alcohol
• if you will be having electroconvulsive therapy (ECT)

Some MEDICINES MAY INTERACT with Sarafem . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anorexiants (eg, phentermine), fenfluramine derivatives (eg, dexfenfluramine), linezolid, MAOIs (eg, phenelzine), metoclopramide, nefazodone, selegiline, serotonin 5-HT1 receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, venlafaxine, St. John's wort, trazodone, or tryptophan because severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur
• Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, may be increased
• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood sodium levels may be increased
• Tramadol because the risk of seizures may be increased
• Cyclobenzaprine or H1 antagonists (eg, astemizole, terfenadine) because severe heart problems, including irregular heartbeat, may occur
• HIV protease inhibitors (eg, ritonavir) because they may increase the risk of Sarafem 's side effects
• Cyproheptadine because it may decrease Sarafem 's effectiveness
• Aripiprazole, benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), carbamazepine, clozapine, dextromethorphan, digoxin, flecainide, haloperidol, hydantoins (eg, phenytoin), lithium, norepinephrine reuptake inhibitors (eg, atomoxetine), phenothiazines (eg, chlorpromazine, thioridazine), pimozide, propafenone, risperidone, tricyclic antidepressants (eg, amitriptyline), or vinblastine because the risk of their side effects may be increased by Sarafem

Possible Side Effects

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

• Anxiety; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; loss of appetite; nausea; nervousness; stomach upset; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

• Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; exaggerated reflexes; excessive sweating; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; increased urination; joint or wrist aches or pain; loss of coordination; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears;persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; significant weight loss; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual hoarseness; unusual or severe mental or mood changes; unusual swelling; vision changes; worsening of depression.

More Information

If you have any questions about Sarafem, please talk with your doctor, pharmacist, or other health care provider.
Sarafem is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.