FLUOXETINE HYDROCHLORIDE - fluoxetine hydrochloride solution 
ANI Pharmaceuticals, Inc.

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Medication Guide

Fluoxetine (floo ox' e teen) Oral Solution, 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:


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:


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

Symptoms in males may include:


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. There may be treatments your healthcare provider can suggest.


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:

Major Depressive Disorder (MDD)

Obsessive Compulsive Disorder (OCD)

Bulimia Nervosa*

Panic Disorder*


*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 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 non-prescription 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®

*Sarafem®


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 SIDEEFFECTS 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 1-855-204-1431 or visit www.novitiumpharma.com.


What are the ingredients in fluoxetine oral solution USP?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: glycerin, purified water, sodium benzoate, artificial cherry flavor, and sucrose, and contains hydrochloric acid to adjust the pH.


All trademarks are the property of their respective owners.


Manufactured by:

Novitium Pharma LLC

70 Lake Drive, East Windsor

New Jersey 08520


Issued: 08/2023

LB4546-02


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

Revised: 7/2023
ANI Pharmaceuticals, Inc.