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    Generic Name: Fluoxetine Capsules and Tablets (floo-OX-e-teen)
    Brand Name: Prozac

    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 Prozac . Be sure that the benefits of taking Prozac outweigh the risks. Talk with the patient's physician if you have any questions.

    Family and caregivers must closely observe patients who use Prozac . 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.


    Prozac is taken for:

    Treating depression or obsessive-compulsive disorder (OCD) in adults and children. It is taken to treat bulimia nervosa and panic disorder in adults. It might also be taken for other conditions as determined by your physician.

    Prozac 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 certain mood problems.

    Do NOT use Prozac if:

    • you are allergic to any ingredient in Prozac
    • 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 Prozac :

    Some medical conditions might interact with Prozac . 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 Prozac . 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 Prozac 's side effects
    • Cyproheptadine because it might decrease Prozac '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 Prozac

    This might not be a complete list of all interactions that might occur. Ask your health care provider if Prozac 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 Prozac :

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

    • Prozac comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Prozac refilled.
    • Use Prozac by mouth with or without food.
    • Taking Prozac at the equal time each day will help you remember to use it.
    • Continue to use Prozac even if you feel well. Do not miss any doses.
    • Do not suddenly stop taking Prozac 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 Prozac and whenever a change in dose is made.
    • If you miss a dose of Prozac , 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 Prozac .

    Important safety information:

    • Prozac might cause drowsiness or dizziness. These effects might be worse if you use it with alcohol or certain medicines. Use Prozac 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 Prozac ; 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 Prozac for longer than prescribed without checking with your physician.
    • Children and teenagers who use Prozac 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 Prozac 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 - Prozac 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 Prozac . Your risk might be greater if you use Prozac 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 Prozac , 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 Prozac .
    • Prozac 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.
    • Use Prozac with caution in the ELDERLY; they might be more sensitive to its effects, especially short blood sodium levels.
    • Caution is advised when taking Prozac in CHILDREN; they might be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
    • Prozac should be taken with extreme caution in CHILDREN younger than 7 years old; safety and effectiveness in these children have not been confirmed.
    • Prozac might cause weight changes. CHILDREN and teenagers might need natural weight and growth checks while they use Prozac .
    • PREGNANCY and BREAST-FEEDING: Prozac 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 Prozac while you are pregnant. Prozac is found in breast milk. Do not breast-feed while you are taking Prozac .

    Possible side effects of Prozac :

    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 Prozac :

    Store Prozac at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and thin. Do not store in the bathroom. Store Prozac out of the reach of children and away from pets.

    General information:

    • If you have any questions about Prozac , please talk with your physician, pharmacist, or other health care provider.
    • Prozac 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 Prozac . 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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