FLUOXETINE - fluoxetine hydrochloride capsule 
Aurobindo Pharma Limited

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Medication Guide


Fluoxetine Capsules, USP

(floo ox' e teen)
 

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 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:



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 capsules 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: 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. 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:




9.  Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia including Torsade de Pointes). This condition can be life threatening. The symptoms may include:



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



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:



* Not approved for use in children

Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s Fluoxetine Capsules. However due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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:



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:




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:



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

How should I take fluoxetine capsules?

  • 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.
  • Fluoxetine capsules may be taken with or without food.
  • 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.
  • If you take too much fluoxetine 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 affect 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:
  

  • See “What is the most important information I should know about fluoxetine capsules?”
  • 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 are stopped. Your healthcare provider may need to change the dose of your diabetes medicines when you start or stop taking fluoxetine capsules.
  • Feeling anxious or trouble sleeping

Common possible side effects in people who take fluoxetine capsules 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 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?


  • Store fluoxetine capsules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
  • Keep fluoxetine capsules away from light.
  • 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. They 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 1-866-850-2876.

What are the ingredients in fluoxetine capsules? 

Active ingredient: fluoxetine hydrochloride 

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

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: 02/2014

Revised: 02/2014
 
Aurobindo Pharma Limited