FLUOXETINE- fluoxetine tablet 
Torrent Pharmaceuticals Limited


Medication Guide


Read the Medication Guide that comes with fluoxetine tablets 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 you want to learn more about.

Fluoxetine tablet is in a class of drugs called selective serotonin reuptake inhibitors (SSRIs), which are often used for the treatment of depression and anxiety disorders. Although fluoxetine tablets are not a treatment for depression, it contains fluoxetine hydrochloride, the same active ingredient in some antidepressants.

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:

            º New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

            º Pay particular attention to such changes when fluoxetine tablets are started or when the dose is changed.

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 condition can be life-threatening and may include:

3. Severe allergic reactions:

4. Manic episodes:

5. Seizures or convulsions

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

7. 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 (NSAID's, like ibuprofen or naproxen), or aspirin.

8. 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.

9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

10. Sexual problems (dysfunction).Taking selective serotonin reuptake inhibitors (SSRIs), including fluoxetine tablets, may cause symptoms of sexual problems

Symptoms in females may include:

ο  Decreased sex drive

ο  Delayed 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 tablets. There may be treatments your healthcare provider can suggest.

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 premenstrual dysphoric disorder (PMDD).

It is not known if fluoxetine tablets are safe and effective in children.

Talk with your healthcare provider if you do not think that your condition is getting better with fluoxetine tablets treatment.

Who should not take fluoxetine tablets?

Do not take fluoxetine tablets if you:

        º Do not take an MAOI within 5 weeks of stopping fluoxetine tablets unless directed to do so by your healthcare provider.

        º Do not start fluoxetine tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.

Women 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:

       º Triptans used to treat migraine headache

       º Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, amphetamines, SSRIs, SNRIs, MAOIs or antipsychotics

       º Tramadol, fentanyl, meperidine, methadone, or other opioids

º Over-the-counter supplements such as tryptophan or St. John's Wort

       º Electroconvulsive therapy (ECT)

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:

How should I take fluoxetine tablets?

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 affects 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:

The most common side effects of fluoxetine tablets 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 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 FDA at 1-800-FDA-1088.

How should I store fluoxetine tablets?

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 it was not prescribed. Do not give fluoxetine tablets to other people, even if they have the same condition. It 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 1-800-912-9561.

What are the ingredients in fluoxetine tablets?

Active ingredient: fluoxetine hydrochloride, USP

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 lake, FD&C Yellow no. 6 lake, magnesium stearate, microcrystalline cellulose, and povidone.

Trade marks are property of their respective owners.

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


Manufactured by:


Manufactured for:

TORRENT PHARMA INC., Basking Ridge, NJ 07920

8093817                                                                                                  August 2023

Revised: 8/2023
Torrent Pharmaceuticals Limited