FLUOXETINE- fluoxetine hydrochloride tablet, film coated
Mylan Pharmaceuticals Inc.
FLUOXETINE TABLETS, USP
(floo ox' e teen)
10 mg and 20 mg
Read the Medication Guide that comes with fluoxetine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
What is the most important information I should know about fluoxetine tablets?
Fluoxetine tablets and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Fluoxetine tablets may be associated with these serious side effects:
2. Serotonin Syndrome. This condition can be life threatening and may include:
3. Severe allergic reactions:
4. Visual problems:
5. Abnormal bleeding: Fluoxetine tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®†, Jantoven®†), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
6. Seizures or convulsions
7. Manic episodes:
8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
10. Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsades de Pointes). This condition can be life threatening. The symptoms may include:
Do not stop fluoxetine tablets without first talking to your healthcare provider. Stopping fluoxetine tablets too quickly may cause serious symptoms including:
What are fluoxetine tablets?
Fluoxetine tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
Fluoxetine tablets are used to treat:
*Not approved for use in children
Talk to your healthcare provider if you do not think that your condition is getting better with fluoxetine tablets treatment.
Who should not take fluoxetine tablets?
Do not take fluoxetine tablets if you:
People who take fluoxetine tablets close in time to an MAOI may have serious or even life threatening side effects. Get medical help right away if you have any of these symptoms:
What should I tell my healthcare provider before taking fluoxetine tablets? Ask if you are not sure.
Before starting fluoxetine tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Fluoxetine tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take fluoxetine tablets with your other medicines. Do not start or stop any medicine while taking fluoxetine tablets without talking to your healthcare provider first.
If you take fluoxetine tablets, you should not take any other medicines that contain fluoxetine hydrochloride including:
How should I take fluoxetine tablets?
What should I avoid while taking fluoxetine tablets?
Fluoxetine tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery or do other dangerous activities until you know how fluoxetine tablets affect you. Do not drink alcohol while using fluoxetine tablets.
What are the possible side effects of fluoxetine tablets?
Fluoxetine tablets may cause serious side effects, including:
Common possible side effects in people who take fluoxetine tablets include:
Other side effects in children and adolescents include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of fluoxetine tablets. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store fluoxetine tablets?
Keep fluoxetine tablets and all medicines out of the reach of children.
General information about fluoxetine tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine tablets for a condition for which it was not prescribed. Do not give fluoxetine tablets to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about fluoxetine tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluoxetine tablets that is written for healthcare professionals.
For more information about fluoxetine tablets, call Mylan Pharmaceuticals Inc. at 1-877-446-3769 (1-877-4-INFO-RX).
What are the ingredients in fluoxetine tablets, USP?
Active ingredients: fluoxetine hydrochloride, USP
Inactive ingredients: crospovidone, hypromellose, magnesium stearate, maize (corn) starch, microcrystalline cellulose, polyethylene glycol, silica colloidal anhydrous, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
† The brands listed are trademarks of their respective owners.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured in Australia by:
ALPHAPHARM PTY LTD
15 Garnet Street
Carole Park QLD 4300
REVISED AUGUST 2014