Uses of Fluoxetine Solution:

• It is used to treat low mood (depression).
• It is used to treat obsessive-compulsive problems.
• It is used to treat eating problems.
• It is used to treat panic attacks.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Fluoxetine Solution?

• If you have an allergy to fluoxetine or any other part of fluoxetine solution.
• If you are allergic to fluoxetine solution; any part of fluoxetine solution; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking any of these drugs: Linezolid, methylene blue, pimozide, or thioridazine.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding. Do not breast-feed while you take fluoxetine solution.

This is not a list of all drugs or health problems that interact with fluoxetine solution.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take fluoxetine solution with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Fluoxetine Solution?

• Tell all of your health care providers that you take fluoxetine solution. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how fluoxetine solution affects you.
• Do not stop taking fluoxetine solution all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop fluoxetine solution, you will want to slowly stop it as ordered by your doctor.
• Avoid drinking alcohol while taking fluoxetine solution.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• It may take several weeks to see the full effects.
• This medicine may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
• Very bad and sometimes deadly reactions along with a rash have rarely happened with fluoxetine solution. Lung, kidney, or liver problems have also happened. Call your doctor right away if you have a change in the amount of urine passed, dark urine, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, yellow skin or eyes, or shortness of breath.
• Some people may have a higher chance of eye problems with fluoxetine solution. Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
• This medicine can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• If you are 65 or older, use fluoxetine solution with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using fluoxetine solution while you are pregnant.
• Taking fluoxetine solution in the third trimester of pregnancy may lead to some health problems in the newborn. Talk with the doctor.

How is this medicine (Fluoxetine Solution) best taken?

Use fluoxetine solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking fluoxetine solution as you have been told by your doctor or other health care provider, even if you feel well.
• Measure liquid doses carefully. Use the measuring device that comes with fluoxetine solution. If there is none, ask the pharmacist for a device to measure fluoxetine solution.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• A big weight gain or loss.
• Sex problems like lowered interest in sex or ejaculation problems.
• Erection that lasts more than 4 hours.
• Seizures.
• Dizziness.
• Slow heartbeat.
• Any unexplained bruising or bleeding.
• Anxiety.
• Very nervous and excitable.
• More thirst.
• Period (menstrual) changes.
• Passing urine more often.
• Trouble controlling body movements.
• A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.
• A type of abnormal heartbeat (prolonged QT interval) has happened with fluoxetine solution. Sometimes, this has led to another type of unsafe abnormal heartbeat (torsades de pointes). Call your doctor right away if you have a fast or abnormal heartbeat, or if you pass out.

What are some other side effects of Fluoxetine Solution?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Not hungry.
• Diarrhea.
• Dry mouth.
• Feeling sleepy.
• Strange or odd dreams.
• Trouble sleeping.
• Feeling tired or weak.
• Flu-like signs.
• Yawning.
• Hot flashes.
• Feeling nervous and excitable.
• Shakiness.
• Sweating a lot.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Fluoxetine Solution?

• Store at room temperature. Do not freeze.
• Protect from light.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time fluoxetine solution is refilled. If you have any questions about fluoxetine solution, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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