FLUOXETINE- fluoxetine hydrochloride capsule 
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Medication Guide


Fluoxetine Capsules, USP

Read the Medication Guide that comes with fluoxetine capsules 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 doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about fluoxetine capsules.

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

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

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


  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 suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal 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 a family member?

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



What else do I need to know about antidepressant medicines?



What are fluoxetine capsules?

Fluoxetine capsules are a prescription medicine used:



It is not known if fluoxetine capsules and olanzapine (Zyprexa®) taken together is safe and works in children under 18 years of age.

The symptoms of depression (Major Depressive Disorder and Bipolar I 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?



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


What should I tell my doctor before taking fluoxetine capsules?


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



Tell your doctor 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 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 with your other medicines. Do not start or stop any medicine while taking fluoxetine capsules without talking to your doctor first.

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



You could take too much medicine (overdose).

How should I take fluoxetine capsules?



What should I avoid while taking fluoxetine capsules?


What are the possible side effects of fluoxetine capsules?

Fluoxetine capsules may be associated with the following serious risks:



Common possible side effects of fluoxetine capsules 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. 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?
 


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. They may harm them.

This Medication Guide summarizes the most important information about fluoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about fluoxetine capsules that was written for healthcare professionals. For more information about fluoxetine capsules call 1-866-850-2876.

What are the ingredients in fluoxetine capsules?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: pregelatinized starch, colloidal silicon dioxide, FD&C Blue #1, yellow iron oxide, titanium dioxide, sodium lauryl sulphate, and gelatin. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide and shellac.

Symbyax ® and Sarafem ® are registered trademarks 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.

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

Manufactured for:

Aurobindo Pharma USA, Inc.

2400 Route 130 North

Dayton, NJ 08810

Manufactured by:

Aurobindo Pharma Limited

Hyderabad–500 072, India

Revised: 07/2010

Revised: 07/2014
 
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