Fluoxetine

Medications such as fluoxetine may increase the risk of suicidal thoughts and actions. This increase was found in children, teenagers, and young adults (less than 24 years of age). The risk may be more likely with the first few months of treatment and when the dose is increased.

Call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fluoxetine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Talk to your doctor about the risks of taking fluoxetine.

Fluoxetine is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), some eating disorders, and panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks). Fluoxetine is also used to relieve the symptoms of premenstrual dysphoric disorder. It is also used along with olanzapine to treat depression and episodes of depression in people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Fluoxetine comes as a capsule, a tablet, a delayed-release (releases the medication in the intestine) capsule, and a solution (liquid) to take by mouth. Take fluoxetine with or without food. Take fluoxetine capsules, tablets, and liquid once a day in the morning or twice a day in the morning and at noon. Take fluoxetine delayed-released capsules once a week. Take fluoxetine at around the same time(s) every day.

Take fluoxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the delayed-release capsules whole; do not cut, crush, or chew them.

Your doctor may start you on a low dose of fluoxetine and gradually increase your dose.

It may take 4 to 5 weeks or longer before you feel the full benefit of fluoxetine. Continue to take fluoxetine even if you feel well. Do not stop taking fluoxetine without talking to your doctor. If you suddenly stop taking fluoxetine, you may experience withdrawal symptoms such as mood changes, irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, sweating, confusion, headache, tiredness, and difficulty falling asleep or staying asleep. Your doctor will probably decrease your dose gradually.

Fluoxetine is also sometimes used to treat alcoholism, attention-deficit disorder, borderline personality disorder, sleep disorders, headaches, mental illness, posttraumatic stress disorder, Tourette's syndrome, obesity, sexual problems, and phobias. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking fluoxetine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: pimozide, thioridazine, or a monoamine oxidase (MAO) inhibitor such as isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine. If you stop taking fluoxetine, you should wait at least 5 weeks before you begin to take thioridazine or a monoamine oxidase inhibitor.
• some medications should not be taken with fluoxetine. Other medications may cause dosing changes or extra monitoring when taken with fluoxetine. Make sure you have discussed any medications you are currently taking or plan to take before starting fluoxetine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking fluoxetine, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with fluoxetine: St. John's wort; tryptophan; aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen and naproxen. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking fluoxetine. Do not start any of these medications while taking fluoxetine without discussing with your healthcare provider.
• tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death). Also tell your doctor if you have a low level of potassium, magnesium, or sodium in your blood or are being treated with electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses). Tell your doctor if you have recently had a heart attack and if you have or have ever had a slow or irregular heartbeat, heart failure, or any other heart problems; high blood pressure; bleeding problems; a stroke; diabetes; seizures; or liver or kidney disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking fluoxetine, call your doctor.
• you should know that fluoxetine may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.
• talk to your doctor about the safe use of alcoholic beverages during your treatment with fluoxetine. Alcohol can make the side effects of fluoxetine worse.
• you should know that fluoxetine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Fluoxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nervousness, anxiety
• difficulty falling asleep or staying asleep
• nausea, heartburn, diarrhea,
• dry mouth
• yawning
• weakness, tiredness
• uncontrollable shaking of a part of the body
• unusual dreams
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
• excessive sweating

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:

• rash, hives, blisters, itching; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• agitation, fever, sweating, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• chest pain, shortness of breath, dizziness, fainting
• seizures
• abnormal bleeding or bruising
• coma (loss of consciousness)
• headache; unsteadiness; problems with thinking, concentration, or memory

Fluoxetine may decrease appetite and decrease weight gain in children. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication.

Fluoxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• agitation, fever, sweating, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• rapid, irregular, or pounding heartbeat
• seizures
• coma (loss of consciousness for a period of time)

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking fluoxetine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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