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Product description Safety information Side Effects

Drug Name

Fluoxetine

Drug Uses

Fluoxetine 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 Fluoxetine as directed by your doctor.

• Take Fluoxetine by mouth with or without food.
• Taking Fluoxetine at the same time each day will help you remember to take it.
• Continue to take Fluoxetine even if you feel well. Do not miss any doses.
• Do not suddenly stop taking Fluoxetine 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 Fluoxetine and whenever a change in dose is made.

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

Drug Class and Mechanism

Fluoxetine 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 Fluoxetine and are using it regularly, 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 Fluoxetine between 68 and 77 degrees F (20 and 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 Fluoxetine out of the reach of children and away from pets.

Warnings/Precautions

Do not use Fluoxetine if:

• you are allergic to any ingredient in Fluoxetine;
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (e.g., phenelzine), selegiline, or St. John's wort within the last 14 days;
• you are taking a fenfluramine derivative (e.g., dexfenfluramine), nefazodone, pimozide, a serotonin norepinephrine reuptake inhibitor (SNRI) (e.g., 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 Fluoxetine . 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 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 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 Fluoxetine 's side effects
• Cyproheptadine because it may 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 may be increased by Fluoxetine

Possible 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 Fluoxetine, please talk with your doctor, pharmacist, or other health care provider.
Fluoxetine is to be used only by the patient for whom it is prescribed. Do not share it with other people.