FLUOXETINE- fluoxetine hydrochloride tablet 
ScieGen Pharmaceuticals, Inc.

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                                                                                                                      MEDICATION GUIDE
                                                                                                                  FLUOXETINE TABLETS

                                                                                                                         (floo-ox-e-teen)

Read the Medication Guide that comes with fluoxetine 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?

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

What are fluoxetine tablets?

Fluoxetine tablets 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 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 fluoxetine treatment.

Who should not take fluoxetine?

Do not take fluoxetine if you:

People 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? Ask if you are not sure.

Before starting fluoxetine, tell your healthcare provider if you:

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

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

  • Symbyax® (olanzapine and fluoxetine hydrochloride)
  • Sarafem® (fluoxetine)
  • Prozac®
  • Prozac® Weekly™

How should I take fluoxetine?


  • Take fluoxetine exactly as prescribed. Your healthcare provider may need to change the dose of fluoxetine tablets until it is the right dose for you. Each tablet can be broken in half (along the functional score).
  • Fluoxetine may be taken with or without food.
  • If you miss a dose of fluoxetine, 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 at the same time.
  • If you take too many fluoxetine, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking fluoxetine?

Fluoxetine 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 affects you. Do not drink alcohol while using fluoxetine.

What are the possible side effects of fluoxetine?

Fluoxetine may cause serious side effects, including:


  • See “What is the most important information I should know about fluoxetine?”
  • Problems with blood sugar control. People who have diabetes and take fluoxetine may have problems with low blood sugar while taking fluoxetine. High blood sugar can happen when fluoxetine is stopped. Your healthcare provider may need to change the dose of your diabetes medicines when you start or stop taking fluoxetine.
  • Feeling anxious or trouble sleeping

Common possible side effects in people who take fluoxetine 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.

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. 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?


  • Store fluoxetine at room temperature between 68°F to 77°F (20° to 25°C).
  • Keep fluoxetine away from light.
  • Keep fluoxetine bottle closed tightly.

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

General information about fluoxetine

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

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

For more information about fluoxetine call ScieGen Pharmaceuticals Inc at 1-855-724-3436.

What are the ingredients in fluoxetine tablets?

Active ingredient: fluoxetine hydrochloride, USP

Inactive ingredients: microcrystalline cellulose, corn starch (maize), povidone, mannitol, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol

This Medication Guide has been approved by the US Food and Drug Administration.
Symbyax and Prozac are registered trademarks of Eli Lilly and Company.
Prozac Weekly is a registered trademark of Eli Lilly and Company.
Sarafem is a registered trademark of Warner Chilcott.
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.

Manufactured by:
ScieGen Pharmaceuticals Inc
Hauppauge, NY 11788
USA

Rev. 05/18

Revised: 4/2019
ScieGen Pharmaceuticals, Inc.