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    Generic Name: Fluoxetine Tablets (PMDD) (floo-OX-e-teen)
    Brand Name: Sarafem

    Antidepressants might increase the risk of suicidal thoughts or actions in children and teenagers. The risk might be greater during the first few months that patients use Fluoxetine . Be sure that the benefits of taking Fluoxetine outweigh the risks. Talk with the patient's physician if you have any questions.

    Family and caregivers must closely observe patients who use Fluoxetine . It is important to store in shut contact with the patient's physician. Tell the physician right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior.


    Fluoxetine is taken for:

    Treating premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome. It might and be taken for other conditions as determined by your physician.

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

    Do NOT use Fluoxetine if:

    • you are allergic to any ingredient in Fluoxetine
    • 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 physician or health care provider right away if any of these apply to you.

    Before taking Fluoxetine :

    Some medical conditions might interact with Fluoxetine . Tell your physician 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 short blood sodium levels, or drink alcohol
    • if you will be having electroconvulsive therapy (ECT)

    Some MEDICINES MIGHT INTERACT with Fluoxetine . 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 might include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, might occur
    • Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of bleeding, including stomach bleeding, might be increased
    • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of short blood sodium levels might be increased
    • Tramadol because the risk of seizures might be increased
    • Cyclobenzaprine or H1 antagonists (eg, astemizole, terfenadine) because severe heart problems, including rough heartbeat, might occur
    • HIV protease inhibitors (eg, ritonavir) because they might increase the risk of Fluoxetine 's side effects
    • Cyproheptadine because it might decrease Fluoxetine '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 might be increased by Fluoxetine

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

    How to use Fluoxetine :

    Use Fluoxetine as directed by your physician. Check the label on the medicine for exact dosing instructions.

    • Fluoxetine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fluoxetine refilled.
    • Use Fluoxetine by mouth with or without food.
    • Taking Fluoxetine at the equal time each day will help you remember to use it.
    • Continue to use Fluoxetine even if you feel well. Do not miss any doses.
    • Do not suddenly stop taking Fluoxetine without checking with your physician. Side effects might occur. They might 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 Fluoxetine and whenever a change in dose is made.
    • If you miss a dose of Fluoxetine , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your natural dosing schedule. Do not use 2 doses at one time.

    Ask your health care provider any questions you might have about how to use Fluoxetine .

    Important safety information:

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

    Possible side effects of Fluoxetine :

    All medicines might cause side effects, however many people have no, or minor, side effects. Check with your physician if any of these most GENERAL 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; dark or bloody stools; chest pain; confusion; exaggerated reflexes; excessive sweating; fast or rough 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 might occur. If you have questions or need medical advice about side effects, contact your physician or health care provider. You might 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 might include coma; confusion; delirium; difficult breathing; fainting; fast, slow, or rough heartbeat; fever; seizures; severe or persistent dizziness, drowsiness, nausea, or vomiting; tremor.

    Proper storage of Fluoxetine :

    Store Fluoxetine 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 thin. Do not store in the bathroom. Store Fluoxetine out of the reach of children and away from pets.

    General information:

    • If you have any questions about Fluoxetine , please talk with your physician, pharmacist, or other health care provider.
    • Fluoxetine is to be taken 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 physician.

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

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