FLUoxetine (Eqv-Sarafem)

FLUoxetine (Eqv-Sarafem) is used to treat:

• major depressive disorder in adults and children aged 8 to 18 years.
• obsessive-compulsive disorder in adults and children aged 7 to 17 years.
• bulimia nervosa (an eating disorder) in adults.
• panic disorder in adults.

FLUoxetine (Eqv-Sarafem) may also be used for other purposes that are not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Call your doctor if your symptoms do not improve, or if they get worse.

Tell your doctor if you notice any changes in sexual function, such as losing interest in sex, having difficulty reaching orgasm, or (in men) experiencing problems with erections or ejaculation. Some sexual problems can be treated.

Measure liquid medicine using the provided measuring device (not a kitchen spoon).

Do not stop using FLUoxetine (Eqv-Sarafem) suddenly, as this could lead to unpleasant symptoms (such as agitation, confusion, tingling, or electric shock sensations). Consult your doctor before stopping the medicine.

You may need to have regular eye exams.

Store tightly closed at room temperature, away from moisture, heat, and light.

You should not use FLUoxetine (Eqv-Sarafem) if you are also taking pimozide or thioridazine.

Do not use FLUoxetine (Eqv-Sarafem) if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before taking FLUoxetine (Eqv-Sarafem). You must wait 5 weeks after stopping FLUoxetine (Eqv-Sarafem) before you can take thioridazine or an MAOI.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when they first start a medicine to treat depression. Tell your doctor right away if you notice any sudden changes in mood or behavior, or if you have thoughts about suicide.

You should not use FLUoxetine (Eqv-Sarafem) if you are allergic to it, or if you also take pimozide or thioridazine.

Do not use FLUoxetine (Eqv-Sarafem) if you have taken an MAO inhibitor in the last 14 days. A serious drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine. You must wait at least 14 days after stopping an MAO inhibitor before taking FLUoxetine (Eqv-Sarafem). You must wait 5 weeks after stopping FLUoxetine (Eqv-Sarafem) before you can take thioridazine or an MAOI.

Tell your doctor if you have or have ever had:

• heart problems or stroke;
• high blood pressure;
• bleeding problems;
• seizures or epilepsy;
• bipolar disorder (manic depression);
• low sodium levels in your blood;
• diabetes;
• narrow-angle glaucoma;
• sexual problems;
• drug abuse or suicidal thoughts;
• electroconvulsive therapy (ECT); or
• liver or kidney disease.

Older adults may be more sensitive to the effects of this medication.

If you are pregnant, your name may be included in a pregnancy registry to monitor the effects of FLUoxetine (Eqv-Sarafem) on the baby.

Ask your doctor about taking FLUoxetine (Eqv-Sarafem) if you are pregnant. Taking FLUoxetine (Eqv-Sarafem) during late pregnancy may lead to serious medical issues for the baby. However, you may experience a relapse of depression if you stop taking your antidepressant. Tell your doctor immediately if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when they first start taking a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

FLUoxetine (Eqv-Sarafem) may cause serious side effects. Call your doctor right away if you have:

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Seek medical attention immediately if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects of FLUoxetine (Eqv-Sarafem) may include:

• feeling like you might pass out;
• sleep problems, strange dreams;
• drowsiness;
• tremors or shaking, feeling anxious or nervous;
• weakness, yawning, tiredness;
• upset stomach, loss of appetite, nausea, vomiting, diarrhea;
• rash, dry mouth, sweating, hot flashes;
• changes in weight or appetite;
• stuffy nose, sinus pain, sore throat, flu symptoms; or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you remember, but skip the missed dose if it is almost time for your next dose. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Overdose symptoms can include seizures, changes in your mental state, fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (as if you might pass out), severe headache, blurred vision, pounding in your neck or ears, agitation, hallucinations, fever, muscle stiffness or twitching, loss of coordination, nausea, and diarrhea.

Avoid drinking alcohol.

Avoid driving or doing dangerous activities until you know how FLUoxetine (Eqv-Sarafem) will affect you. Your reactions may be impaired.

FLUoxetine (Eqv-Sarafem) can lead to a serious heart issue. Your risk might increase if you are also taking certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using FLUoxetine (Eqv-Sarafem) along with other medications that cause drowsiness can make this effect worse. Check with your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Consult your doctor before using a nonsteroidal anti-inflammatory drug (NSAID) like aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Taking an NSAID with FLUoxetine (Eqv-Sarafem) might cause you to bruise or bleed more easily.

Inform your doctor about all the medicines you are currently taking. Many drugs can affect FLUoxetine (Eqv-Sarafem), especially:

• any other antidepressant;
• St. John's Wort;
• tryptophan (sometimes known as L-tryptophan);
• a blood thinner—warfarin, Coumadin, Jantoven;
• medicine for anxiety, mood disorders, thought disorders, or mental illness—buspirone, desipramine, lithium, and many others;
• medicine for ADHD or narcolepsy—such as amphetamines;
• migraine headache medicine—rizatriptan, sumatriptan, zolmitriptan, and others; or
• narcotic pain medicine—fentanyl, tramadol, meperidine, methadone.

This list is not exhaustive, and many other drugs may interact with FLUoxetine (Eqv-Sarafem). This includes both prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.