PROzac; PROzac Weekly [DSC]; Sarafem
Apo-Fluoxetine; Ava-Fluoxetine; CO Fluoxetine; Dom-Fluoxetine; Fluoxetine Capsules BP; FXT 40; Gen-Fluoxetine; JAMP-Fluoxetine; Mint-Fluoxetine; Mylan-Fluoxetine; Novo-Fluoxetine; Nu-Fluoxetine; PHL-Fluoxetine; PMS-Fluoxetine; PRO-Fluoxetine; Prozac; Q-Fluoxetine; ratio-Fluoxetine; Riva-Fluoxetine; Sandoz-Fluoxetine; Teva-Fluoxetine; ZYM-Fluoxetine
- Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
- This drug is not approved for use in all children. Talk with the doctor to be sure that this drug is right for your child.
- It is used to treat low mood (depression).
- It is used to treat obsessive-compulsive problems.
- It is used to treat mood problems caused by monthly periods.
- It is used to treat eating problems.
- It is used to treat panic attacks.
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child is taking any of these drugs: Linezolid, methylene blue, pimozide, or thioridazine.
- If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
- If your child is 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 the doctor or pharmacist if you are not sure.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
- If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
- It may take several weeks to see the full effects.
- This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
- This drug may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
- Some people may have a higher chance of eye problems with this drug. The doctor may want your child to have an eye exam to see if your child has a higher chance of these eye problems. Call the doctor right away if your child has eye pain, change in eyesight, or swelling or redness in or around the eye.
- This drug can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death. Talk with the doctor.
- Use with care in children. Talk with the doctor.
- This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
If your child is pregnant:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
- Taking this drug in the third trimester of pregnancy may lead to some health problems in the newborn. Talk with the doctor.
- 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.
- Any unexplained bruising or bleeding.
- Very nervous and excitable.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call your child’s doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; a fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
- Call your child’s doctor right away if your child gets a painful erection (hard penis) or gets an erection that lasts for longer than 4 hours. If this is not treated right away, it may lead to lasting sex problems and your child may not be able to have sex in the future.
- Very bad and sometimes deadly reactions along with a rash have rarely happened with this drug. Lung, kidney, or liver problems have also happened. Call the doctor right away if your child has 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.
- A type of abnormal heartbeat (prolonged QT interval) has happened with this drug. Sometimes, this has led to another type of unsafe abnormal heartbeat (torsades de pointes). Call your child’s doctor right away if your child has a fast or abnormal heartbeat, or if your child passes out.
If your child is or may be sexually active:
- Sex problems like lowered interest in sex or ejaculation problems.
- Upset stomach or throwing up.
- Not hungry.
- Dry mouth.
- Loose stools (diarrhea).
- Not able to sleep.
- Feeling sleepy.
- Strange or odd dreams.
- Feeling tired or weak.
- Flu-like signs.
- Hot flashes.
- Feeling nervous and excitable.
- Sweating a lot.
- Give this drug with or without food.
- To gain the most benefit, do not miss giving your child doses.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Store at room temperature. Do not freeze.
- Store in a dry place. Do not store in a bathroom.
- Protect from light.
- Keep lid tightly closed.
- 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.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, 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.