Sarafem (Fluoxetine)

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.

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.

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

• 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)

• 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

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.

• 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.

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.