FLUOXETINE- fluoxetine hydrochloride tablet, film coated 
Teva Pharmaceuticals USA Inc

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MEDICATION GUIDE

FLUOXETINE (floo-OX-e-teen)

TABLETS USP

Read the Medication Guide that comes with fluoxetine tablets before you start taking them 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 conditioncan be life-threatening and may include:

 

3. Severe allergic reactions:

 

4. 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.

 

5. Seizures or convulsions

 

6. Manic episodes:

 

7. Changes in appetite or weight. Children and adolescents should have height and weight
monitored during treatment.

 

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this.

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 tablet 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:

  • Symbyax®
  • Sarafem®
  • Prozac® Weekly

How should I take fluoxetine tablets?

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

 

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:

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

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

  • unusual dreams
  • sexual problems
  • loss of appetite, diarrhea, indigestion, nausea or vomiting, weakness, or dry mouth
  • flu symptoms
  • feeling tired or fatigued
  • change in sleep habits
  • yawning
  • sinus infection or sore throat
  • tremor or shaking
  • sweating
  • feeling anxious or nervous
  • hot flashes
  • rash

Other side effects in children and adolescents include:

  • increased thirst
  • abnormal increase in muscle movement or agitation
  • nose bleed
  • urinating more often
  • heavy menstrual periods
  • possible slowed growth rate and weight change. Your child’s height and weight should be

monitored during treatment with fluoxetine tablets.

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 THE FDA AT 1-800-FDA-1088.

 

How should I store fluoxetine tablets?

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

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 they were not prescribed. Do not give fluoxetine tablets to other people, even if they have the same condition. They 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 1-888-838-2872.

What are the ingredients in fluoxetine tablets?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, talc, and titanium dioxide.

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

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.

Zyprexa® is a registered trademark of Eli Lilly and Company.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. E 5/2013

Revised: 09/2013
 
Teva Pharmaceuticals USA Inc