FLUOXETINE HYDROCHLORIDE- fluoxetine hydrochloride capsule, delayed release pellets 
Dr.Reddy's Laboratories Limited

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Medication Guide

Fluoxetine (floo ox’ e teen) Delayed-Release Capsules, USP (Once-Weekly)

Read the Medication Guide that comes with fluoxetine delayed-release 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 delayed-release capsules?

Fluoxetine delayed-release 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 delayed-release 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 delayed-release 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:

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 notstop fluoxetine delayed-release capsules without first talking to your healthcare provider. Stopping fluoxetine delayed-release capsules too quickly may cause serious symptoms including:

11. Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including fluoxetine delayed-release capsules, may cause sexual problems.

Symptoms in males may include:

o Delayed ejaculation or inability to have an ejaculation

o Decreased sex drive

o Problems getting or keeping an erection

Symptoms in females may include:

o Decreased sex drive

o Delayed orgasm or inability to have an orgasm

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with fluoxetine delayed-release capsules. There may be treatments your healthcare provider can suggest.

What are fluoxetine delayed-release capsules?

Fluoxetine delayed-release capsules are 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 delayed-release capsules are used to treat:

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

Who should not take fluoxetine delayed-release capsules?

Do not take fluoxetine delayed-release capsules if you:

People who take fluoxetine delayed-release 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 delayed-release capsules? Ask if you are not sure. 

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

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

If you take fluoxetine delayed-release capsules, you should not take any other medicines that contain fluoxetine hydrochloride including:  

How should I take fluoxetine delayed-release capsules?

What should I avoid while taking fluoxetine delayed-release capsules?

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

What are the possible side effects of fluoxetine delayed-release capsules?

Fluoxetine  delayed-release capsules may cause serious side effects, including:

Common possible side effects in people who take fluoxetine delayed-release capsules 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 fluoxetine delayed-release 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 delayed-releasecapsules?

Keep fluoxetine delayed-releasecapsules and all medicines out of the reach of children.  

General information about fluoxetine delayed-releasecapsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use fluoxetine delayed-release capsules for a condition for which it was not prescribed. Do not give fluoxetine delayed-release 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 delayed-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about fluoxetine delayed-release capsules that is written for healthcare professionals.  For more information about fluoxetine call 1-888-375-3784. 

What are the ingredients in fluoxetine delayed-releasecapsules?  

Active ingredient: fluoxetine hydrochloride USP

Inactive ingredients: black iron oxide, copovidone, gelatin, glycine, hypromellose, hypromellose phthalate, isopropyl alcohol, methylene chloride, red iron oxide, sugar globules, talc, titanium dioxide, triethyl citrate and yellow iron oxide. 

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

Mellaril® is a registered trademark of Novartis AG Corporation.

Trademarks are the property of their respective owners.

Rx Only 

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA   

Revised: 0621

Dispense with Medication Guide available at:

www.drreddys.com/medguide/fluoxetinedrcaps.pdf

                      

Revised: 6/2021
Dr.Reddy's Laboratories Limited