This medicine is a selective serotonin reuptake inhibitor (SSRI) 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.
Follow the directions for taking this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE with or without food. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. Other brands of this medicine that contain the same ingredient (fluoxetine) as this medicine are available. These other brands may be used to treat depression or other mental problems. DO NOT TAKE THIS MEDICINE if you are taking any other medicine that contains fluoxetine. Discuss any questions or concerns with your doctor. Taking this medicine at the same time each day will help you remember to take it. Continue to take this medicine even if you feel well. Do not miss any doses. DO NOT SUDDENLY STOP TAKING THIS MEDICINE 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 this medicine and whenever a change in dose is made. IF YOU MISS A DOSE of this medicine, 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.
WARNING: Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using this medicine outweigh the risks. Family and caregivers must closely watch patients who take this medicine. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days. DO NOT TAKE THIS MEDICINE IF you are taking a fenfluramine derivative (eg, dexfenfluramine), nefazodone, pimozide, a serotonin norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), another SSRI (eg, paroxetine), sibutramine, thioridazine, or tryptophan. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anorexiants (eg, phentermine), fentanyl, meperidine, metoclopramide, rasagiline, serotonin 5-HT1 receptor agonists (eg, sumatriptan), trazodone, anticoagulants (eg, warfarin), aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, intranasal ketorolac), diuretics (eg, furosemide, hydrochlorothiazide), tramadol, HIV protease inhibitors (eg, ritonavir), terbinafine, cyproheptadine, aripiprazole, benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), bupropion, carbamazepine, clozapine, digoxin, flecainide, haloperidol, hydantoins (eg, phenytoin), iloperidone, lithium, norepinephrine reuptake inhibitors (eg, atomoxetine), phenothiazines (eg, chlorpromazine), propafenone, risperidone, tamoxifen, tetrabenazine, tricyclic antidepressants (eg, amitriptyline), vinblastine, or methylene blue. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including if you have a history of seizures, stroke, heart problems, high blood pressure, liver problems, kidney problems, bleeding problems, diabetes, metabolism problems, narrow-angle glaucoma or risk for narrow-angle glaucoma, allergies, pregnancy, or breast-feeding. Tell your doctor 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. Tell your doctor if you are dehydrated, have low blood sodium levels, drink alcohol, or if you will be having electroconvulsive therapy (ECT). Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include anxiety; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms (eg, fever, chills, muscle aches); increased sweating; loss of appetite; nausea; nervousness; runny nose; sore throat; stomach upset; trouble sleeping; or weakness. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY CAUSE decreased sexual desire or ability. This has occasionally been reported to continue after treatment has been stopped. Discuss any questions or concerns with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience black or bloody stools; chest pain; confusion; difficulty concentrating; exaggerated reflexes; excessive sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; joint or wrist aches or pain; loss of coordination; memory problems; new or worsening mental, mood, or behavior changes (eg, depression, anxiety, 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; persistent trouble sleeping; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, diarrhea, or stomach pain; significant weight loss; suicidal thoughts or attempts; tremor; trouble urinating; unusual bruising or bleeding; unusual weakness; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center 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.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.