Product description

Fluoxetine

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.

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.

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.

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.

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.

Safety information

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.

• Do not drink alcohol while you are using Fluoxetine.
• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Fluoxetine; 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 Fluoxetine for longer than prescribed without checking with your doctor.
• Children, teenagers, and young adults who take Fluoxetine may be at increased risk for suicidal thoughts or actions. Watch all patients who take Fluoxetine 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 change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Diabetes patients - Fluoxetine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• 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.
• Fluoxetine 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.
• Pregnancy and breast-feeding: Fluoxetine 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 Fluoxetine while you are pregnant. Fluoxetine is found in breast milk. Do not breast-feed while you are taking Fluoxetine.

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.

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.