PROZAC  WEEKLY- fluoxetine hydrochloride capsule, delayed release 
Eli Lilly and Company

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Medication Guide

PROZAC® (PRO-zac)

(fluoxetine hydrochloride)

Pulvule® and Weekly Capsule

Read the Medication Guide that comes with PROZAC 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 PROZAC?

PROZAC 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. PROZAC 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. Abnormal bleeding: PROZAC 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:

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:

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 PROZAC without first talking to your healthcare provider. Stopping PROZAC too quickly may cause serious symptoms including:

What is PROZAC?

PROZAC is 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.

PROZAC is 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 PROZAC treatment.

Who should not take PROZAC?

Do not take PROZAC if you:

People who take PROZAC 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)

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

Before starting PROZAC, 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. PROZAC 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 PROZAC with your other medicines. Do not start or stop any medicine while taking PROZAC without talking to your healthcare provider first.

If you take PROZAC, you should not take any other medicines that contain fluoxetine hydrochloride including:
  • Symbyax
  • Sarafem
  • Prozac Weekly

How should I take PROZAC?

What should I avoid while taking PROZAC?

PROZAC 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 PROZAC affects you. Do not drink alcohol while using PROZAC.

What are the possible side effects of PROZAC?

PROZAC may cause serious side effects, including:

Common possible side effects in people who take PROZAC 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 PROZAC. 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 PROZAC?

Keep PROZAC and all medicines out of the reach of children.

General information about PROZAC

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

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

For more information about PROZAC call 1-800-Lilly-Rx (1-800-545-5979).

What are the ingredients in PROZAC?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients:

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

Medication Guide revised July 18, 2014

Marketed by: Lilly USA, LLC

Indianapolis, IN 46285, USA

Copyright © 2009, 2014, Eli Lilly and Company. All rights reserved.

PRZ-0001-MG-20140718

Revised: 07/2014
 
Eli Lilly and Company