Medication guide

What is the most important information I should know about fluoxetine capsules USP?

Antidepressant medicines, depression and other serious mental illnesses, and suicidalthoughts or actions:

Talk to your, or your family member's, healthcare provider about:

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all risks and benefits of treatment with antidepressant medicines

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all treatment choices for depression or other serious mental illness

1.

Antidepressant medicines may increase suicidal thoughts or actions in some children,teenagers, and young adults within the first few months of treatment.

2.

Depression and other serious mental illnesses are the most important causes of suicidalthoughts and actions. Some people may have a particularly high risk of havingsuicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3.

How can I watch for and try to prevent suicidal thoughts and actions in myself or afamily member?

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Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

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Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

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Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the followingsymptoms, especially if they are new, worse, or worry you:

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thoughts about suicide or dying

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attempts to commit suicide

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new or worse depression

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new or worse anxiety

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feeling very agitated or restless

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panic attacks

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trouble sleeping (insomnia)

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new or worse irritability

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acting aggressive, being angry, or violent

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acting on dangerous impulses

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an extreme increase in activity and talking (mania)

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or other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

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Never stop an antidepressant medicine without first talking to a healthcareprovider. Stopping an antidepressant medicine suddenly can cause other symptoms.

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Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

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Antidepressant medicines have other side effects. Talk to the healthcare provider

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about the side effects of the medicine prescribed for you or your family member.

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Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

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Not all antidepressant medicines prescribed for children are FDA approved for usein children. Talk to your child’s healthcare provider for more information.

What are fluoxetine capsules USP?

Fluoxetine capsules USP are a prescription medicine used:

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for short and long-term treatment of depression in adults and children over the age of 8.

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for short and long-term treatment of Obsessive Compulsive Disorder (OCD) in adults and children over the age of 7.

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for short and long-term treatment of Bulimia Nervosa in adults.

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for short-term treatment of Panic Disorder, with or without agoraphobia, in adults.

The symptoms of depression (Major Depressive Disorder) include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior. With treatment, some of your symptoms of depression may improve.

OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). With treatment, some of your symptoms of OCD may improve.

Panic Disorder is an anxiety disorder that includes panic attacks, which are sudden feelings of terror for no reason. You may also have physical symptoms, such as; fast heartbeat, chest pain, breathing difficulty, dizziness. With treatment, some of your symptoms of Panic Disorder may improve.

Bulimia Nervosa, involves periods of overeating followed by purging (e.g., vomiting, excessive laxative use). With treatment, some of your symptoms of Bulimia Nervosa may improve.

If you do not think you are getting better, call your doctor.

Who should not take fluoxetine capsules USP?

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Do not take fluoxetine capsules USP if you take a Monoamine Oxidase Inhibitor (MAOI) or if you stopped taking an MAOI in the last 2 weeks.

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Do not take an MAOI within 5 weeks of stopping fluoxetine capsules USP. People who take fluoxetine capsules USP close in time to an MAOI can have serious and lifethreatening side effects, with symptoms including:

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high fever

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continued muscle spasms that you can not control

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rigid muscles

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changes in heart rate and blood pressure that happen fast

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confusion

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unconsciousness

Ask your doctor or pharmacist if you are not sure if your medicine is an MAOI.

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Do not take fluoxetine capsules USP if you take Mellaril® (thioridazine). Do not take Mellaril®within 5 weeks of stopping fluoxetine capsules USP. Mellaril® can causeserious heart rhythm problems and you could die suddenly.

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Do not take fluoxetine capsules USP if you take the antipsychotic medicine pimozide (Orap®).

What should I tell my doctor before taking fluoxetine capsules USP?

Fluoxetine capsules USP may not be right for you. Before starting fluoxetine capsules USP, tell your doctor about all your medical conditions, including if you have or had any of the following:

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seizures (convulsions)

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bipolar disorder (mania)

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are pregnant or plan to become pregnant. It is not known if fluoxetine capsules USP will harm your unborn baby.

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are breast-feeding or plan to breast-feed. Fluoxetine can pass into your breast milk and may harm your baby. You should not breast-feed while taking fluoxetine capsules USP. Talk to your doctor about the best way to feed your baby if you take fluoxetine capsules USP.

Tell your doctor about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Fluoxetine capsules USP and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take fluoxetine capsules USP with your other medicines. Do not start or stop any medicine while taking fluoxetine capsules USP without talking to your doctor first.

If you take fluoxetine capsules USP, you should not take any other medicines that containfluoxetine hydrochloride:

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Symbyax®

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Sarafem®

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Prozac® Weekly™

You could take too much medicine (overdose).

How should I take fluoxetine capsules USP?

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Take fluoxetine capsules USP exactly as prescribed. Your doctor may need to change (adjust) the dose of fluoxetine capsules USP until it is right for you.

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If you miss a dose of fluoxetine capsules USP, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of fluoxetine capsules USP at the same time.

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To prevent serious side effects, do not stop taking fluoxetine capsules USP suddenly.If you need to stop taking fluoxetine capsules USP, your doctor can tell youhow to safely stop taking them.

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If you take too many fluoxetine capsules USP, call your doctor or poison controlcenter right away, or get emergency treatment.

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Fluoxetine capsules USP can be taken with or without food.

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Fluoxetine capsules USP are usually taken once a day.

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If you do not think you are getting better or have any concerns about your condition while taking fluoxetine capsules USP, call your doctor.

What should I avoid while taking fluoxetine capsules USP?

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Fluoxetine capsules USP can cause sleepiness and 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 capsules USP affect you.

What are the possible side effects of fluoxetine capsules USP?

Fluoxetine capsules USP may be associated with the following serious risks:

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Serotonin Syndrome: This is a condition that can be life threatening. Call your doctor right away if you become severely ill and have some or all of these symptoms:

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agitation

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hallucinations

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problems with coordination

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racing heart beat

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over-active reflexes

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fever

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nausea, vomiting, and diarrhea

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Severe allergic reactions: Tell your doctor right away if you get red itchy welts (hives) or, a rash alone or with fever and joint pain, while taking fluoxetine capsules USP. Call your doctor right away if you become severely ill and have some or all of these symptoms:

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swelling of your face, eyes, or mouth

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trouble breathing

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Abnormal bleeding: Tell your doctor if you notice any increased or unusual bruising or bleeding while taking fluoxetine capsules USP, especially if you take one of these medicines:

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the blood thinner warfarin (Coumadin®, Jantoven®)

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a non-steroidal anti-inflammatory drug (NSAID)

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aspirin

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Mania: You may have a high mood, become extremely irritable, have too much energy, feel pressure to keep talking, or have a decreased need for sleep.

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Seizures

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Loss of appetite

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Low salt (sodium) levels in the blood (hyponatremia): Call your doctor right away if you become severely ill and have some or all of these symptoms:

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headache

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feel weak

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confusion

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problems concentrating

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memory problems

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feel unsteady

Common possible side effects of fluoxetine capsules USP include: abnormal dreams, orgasm problems, decreased appetite, anxiety, weakness, diarrhea, dry mouth, indigestion, flu, difficulty maintaining an erection for sexual activity, trouble sleeping, decreased sex drive, feeling sick to your stomach, nervousness, sore throat, rash, watery nasal discharge, sleepiness, sweating, tremor (shakes), hot flashes, and yawn.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects with fluoxetine capsules USP. For more information, ask your doctor 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 capsules USP?

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Store fluoxetine capsules USP at room temperature, between 68°F to 77°F (20°C to 25°C).

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Keep fluoxetine capsules USP away from light.

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Keep fluoxetine capsules USP bottle closed tightly.

Keep fluoxetine capsules USP and all medicines out of the reach of children.

General information about fluoxetine capsules USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine capsules USP for a condition for which they were not prescribed. Do not give fluoxetine capsules USP to other people, even if they have the same condition. They may harm them.

This Medication Guide summarizes the most important information about fluoxetine capsules USP. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about fluoxetine capsules USP that was written for healthcare professionals. For more information about fluoxetine capsules USP call 1-888-838-2872, MEDICAL AFFAIRS.

What are the ingredients in fluoxetine capsules USP?

Active ingredient: fluoxetine hydrochloride.

Inactive ingredients: black iron oxide, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, titanium dioxide.

Symbyax® and Sarafem® are registered trademarks of Eli Lilly and Company.

Prozac® Weekly™ is a trademark of Eli Lilly and Company.

Mellaril® is a registered trademark of Novartis AG Corporation.

Orap® is a registered trademark of Teva Pharmaceuticals USA.

Coumadin® is a registered trademark of Bristol Myers Squibb.

Jantoven® is a registered trademark of Upsher-Smith Laboratories Inc.

Manufactured In Canada By:

NOVOPHARM LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. B 4/2009

361-33-726766200 Rev. 05

Fluoxetine Capsules USP 20 mg are available from Cardinal Health in unit dose cartons of 30.

Cardinal Health

Zanesville, OH 43701

OI82200110