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|Sarafem

Sarafem

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.

This medicine 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

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

Before using Sarafem :

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sarafem may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sarafem :

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.
• 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.

Ask your health care provider any questions you may have about how to use Sarafem .

Important safety information:

• Sarafem may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Take Sarafem with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Sarafem ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or take Sarafem for longer than prescribed without checking with your doctor.
• Children and teenagers who take Sarafem may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if a family member has had it. Watch patients who take this medicine closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Diabetes patients - Sarafem may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Serotonin syndrome is a possibly fatal syndrome that can be caused by Sarafem . Your risk may be greater if you take Sarafem with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
• If your doctor tells you to stop taking Sarafem , you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone, thioridazine). Ask your doctor when you should start to take your new medicines after you have stopped taking Sarafem .
• Sarafem may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
• Caution is advised when using Sarafem in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
• Sarafem should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• Sarafem may cause weight changes. CHILDREN and teenagers may need regular weight and growth checks while they take Sarafem .
• PREGNANCY and BREAST-FEEDING: Sarafem may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sarafem while you are pregnant. Sarafem is found in breast milk. Do not breast-feed while you are taking Sarafem .

Possible side effects of 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.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; confusion; delirium; difficult breathing; fainting; fast, slow, or irregular heartbeat; fever; seizures; severe or persistent dizziness, drowsiness, nausea, or vomiting; tremor.

Store Sarafem at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sarafem out of the reach of children and away from pets.

General 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.

This information is summary only. It does not contain all information about Sarafem . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.