FLUOXETINE- fluoxetine hydrochloride tablet 
Nivagen Pharmaceuticals, Inc.

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MEDICATION GUIDE
FLUOXETINE (floo-OX-e-teen)
TABLETS USP

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:
  • Fluoxetine and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    -
    New or sudden changes in mood, behavior, actions, thoughts, or feelings,especially if severe.
    -
    Pay particular attention to such changes when fluoxetine is 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 may be associated with these serious side effects:

2.
Serotonin Syndrome. This condition can be life-threatening and may include:
  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
  • dizziness
  • flushing
  • tremor
  • seizures
3.
Severe allergic reactions:
  • trouble breathing
  • swelling of the face, tongue, eyes or mouth
  • rash, itchy welts (hives) or blisters, alone or with fever or joint pain
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
  • 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:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
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:
  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems
10.
Changes in the electrical activity of your heart (QT prolongation and ventricular arrhythmia includingTorsades de Pointes). This condition can be life threaten ing.The symptoms may include:
  • fast, slow, or irregular heartbeat
  • shortness of breath
  • dizziness or fainting

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

What is fluoxetine?

Fluoxetine is 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:

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 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:

-
high fever
-
uncontrolled muscle spasms
-
stiff muscles
-
rapid changes in heart rate or blood pressure
-
confusion
-
loss of consciousness (pass out)

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:

How should I take fluoxetine?

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:

Common possible side effects in people who take fluoxetine 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. 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?

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 1-877-977-0687.

What are the ingredients in fluoxetine tablets, 60 mg?

Active ingredient: Fluoxetine hydrochloride USP

Inactive ingredients: Corn starch, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

This Medication Guide has been approved by the U.S. 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:
Inventia Healthcare Limited,
Plot No.F1 & F-1/1, Additional Ambernath M.I.D.C.,
Ambernath (East)-421506,
Dist. Thane, Maharashtra, India

Manufactured for:
Nivagen Pharmaceuticals, Inc.
Sacramento, CA 95827, USA
Toll Free Number: 1-877-977-0687

Revised: July 2018


4
Not approved for use in children.
Revised: 1/2021
Nivagen Pharmaceuticals, Inc.