MEDICATION GUIDE

Fluoxetine Capsules, USP

(floo ox' e teen)

Read the Medication Guide that comes with fluoxetine capsules 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 capsules?

Fluoxetine capsules and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

1. Fluoxetine capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
3. Watch for these changes and call your healthcare provider right away if you notice:
   1. New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
   2. Pay particular attention to such changes when fluoxetine capsules are started or when the dose is changed.

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:

1. attempts to commit suicide
2. acting on dangerous impulses
3. acting aggressive or violent
4. thoughts about suicide or dying
5. new or worse depression
6. new or worse anxiety or panic attacks
7. feeling agitated, restless, angry or irritable
8. trouble sleeping
9. an increase in activity or talking more than what is normal for you
10. other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Fluoxetine capsules may be associated with these serious side effects:

2. Serotonin Syndrome. This condition can be life-threatening and may include:

1. agitation, hallucinations, coma or other changes in mental status
2. coordination problems or muscle twitching (overactive reflexes)
3. racing heartbeat, high or low blood pressure
4. sweating or fever
5. nausea, vomiting, or diarrhea
6. muscle rigidity
7. dizziness
8. flushing
9. tremor
10. seizures

3. Severe allergic reactions:

1. trouble breathing
2. swelling of the face, tongue, eyes or mouth
3. rash, itchy welts (hives) or blisters, alone or with fever or joint pain

4. Abnormal bleeding: fluoxetine capsules 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.

5. Visual problems:

• eye pain
• changes in vision
• swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

6. Seizures or convulsions

7. Manic episodes:

1. greatly increased energy
2. severe trouble sleeping
3. racing thoughts
4. reckless behavior
5. unusually grand ideas
6. excessive happiness or irritability
7. talking more or faster than usual

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:

1. headache
2. weakness or feeling unsteady
3. confusion, problems concentrating or thinking or memory problems

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:

1. fast, slow or irregular heartbeat
2. shortness of breath
3. dizziness or fainting

Do not stop fluoxetine capsules without first talking to your healthcare provider. Stopping fluoxetine capsules too quickly may cause serious symptoms including:

1. anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
2. headache, sweating, nausea, dizziness
3. electric shock-like sensations, shaking, confusion

What are fluoxetine capsules?

Fluoxetine capsules 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 capsules are used to treat:

1. Major Depressive Disorder (MDD)
2. Obsessive Compulsive Disorder (OCD)
3. Bulimia Nervosa*
4. Panic Disorder*
5. Depressive episodes associated with Bipolar I Disorder, taken with olanzapine (Zyprexa)

*Not approved for use in children

Talk to your healthcare provider if you do not think that your condition is getting better with fluoxetine capsules treatment.

Who should not take fluoxetine capsules?

Do not take fluoxetine capsules if you:

1. are allergic to fluoxetine hydrochloride or any of the ingredients in fluoxetine capsules. See the end of this Medication Guide for a complete list of ingredients in fluoxetine capsules.
2. take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
   1. Do not take an MAOI within 5 weeks of stopping fluoxetine capsules unless directed to do so by your physician.
   2. Do not start fluoxetine capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take fluoxetine capsules 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:

• • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)
• take Mellaril® (thioridazine). Do not take Mellaril® within 5 weeks of stopping fluoxetine capsules because this can cause serious heart rhythm problems or sudden death.
• take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.

What should I tell my healthcare provider before taking fluoxetine capsules?Ask if you are not sure.

Before starting fluoxetine capsules, tell your healthcare provider if you:

1. Are taking certain drugs or treatments such as:
   1. Triptans used to treat migraine headache
   2. Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs, MAOIs or antipsychotics
   3. Amphetamines
   4. Tramadol and fentanyl
   5. Over-the-counter supplements such as tryptophan or St. John’s Wort
   6. Electroconvulsive therapy (ECT)
2. have liver problems
3. have kidney problems
4. have heart problems
5. have or had seizures or convulsions
6. have bipolar disorder or mania
7. have low sodium levels in your blood
8. have a history of a stroke
9. have high blood pressure
10. have or had bleeding problems
11. are pregnant or plan to become pregnant. It is not known if fluoxetine capsules will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
12. are breast-feeding or plan to breast-feed. Some fluoxetine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking fluoxetine capsules.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Fluoxetine capsules 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 capsules with your other medicines. Do not start or stop any medicine while taking fluoxetine capsules without talking to your healthcare provider first.

If you take fluoxetine capsules, you should not take any other medicines that contain fluoxetine hydrochloride including: Symbyax® Sarafem® Prozac® Weekly™

How should I take fluoxetine capsules?

1. Take fluoxetine capsules exactly as prescribed. Your healthcare provider may need to change the dose of fluoxetine capsules until it is the right dose for you.
2. Fluoxetine capsules may be taken with or without food.
3. If you miss a dose of fluoxetine capsules, 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 at the same time.
4. If you take too much fluoxetine capsules, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking fluoxetine capsules?

Fluoxetine capsules 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 capsules affects you. Do not drink alcohol while using fluoxetine capsules.

What are the possible side effects of fluoxetine capsules?

Fluoxetine capsules may cause serious side effects, including:

1. See “What is the most important information I should know about fluoxetine capsules?”
2. Problems with blood sugar control. People who have diabetes and take fluoxetine capsules may have problems with low blood sugar while taking fluoxetine capsules. High blood sugar can happen when fluoxetine capsules is stopped. Your healthcare provider may need to change the dose of your diabetes medicines when you start or stop taking fluoxetine capsules.
3. Feeling anxious or trouble sleeping

Common possible side effects in people who take fluoxetine capsules include:

1. unusual dreams
2. sexual problems
3. loss of appetite, diarrhea, indigestion, nausea or vomiting, weakness, or dry mouth
4. flu symptoms
5. feeling tired or fatigued
6. change in sleep habits
7. yawning
8. sinus infection or sore throat
9. tremor or shaking
10. sweating
11. feeling anxious or nervous
12. hot flashes
13. rash

Other side effects in children and adolescents include:

1. increased thirst
2. abnormal increase in muscle movement or agitation
3. nose bleed
4. urinating more often
5. heavy menstrual periods
6. possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with fluoxetine capsules.

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 capsules. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store fluoxetine capsules?

1. Store fluoxetine capsules at room temperature between 20° to 25°C (68° to 77°F).
2. Keep fluoxetine capsules away from light.
3. Keep fluoxetine capsules bottle closed tightly.

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

General information about fluoxetine capsules

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

This Medication Guide summarizes the most important information about fluoxetine capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluoxetine capsules that is written for healthcare professionals.

For more information about fluoxetine capsules call Sandoz Inc. at 1-800-525-8747.

What are the ingredients in fluoxetine capsules?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: corn starch, gelatin, magnesium stearate, pregelatinized starch, propylene glycol, sodium lauryl sulfate, shellac and titanium dioxide. The 10 and 20 mg capsules also contain D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake; the 20 mg capsule also contains Black Iron Oxide, FD&C Blue #2 Aluminum Lake, and FD&C Red #40 Aluminum Lake; the 40 mg capsule also contains ammonium hydroxide, potassium hydroxide, Red Iron Oxide, and Yellow Iron Oxide.

The following are registered trademarks of their respective manufacturers: Symbyax®, Sarafem®, Prozac® Weekly™ , Zyprexa®/Eli Lilly and Company; Mellaril®/Novartis AG Corporation; Orap®/Teva Pharmaceuticals USA; Coumadin®/Bristol Myers Squibb; Jantoven®/Upsher-Smith Laboratories Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.