FLUOXETINE  - fluoxetine hydrochloride liquid 
Silarx Pharmaceuticals, Inc

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Medication Guide

Fluoxetine 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 oral solution?

Fluoxetine oral solution 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 oral solution may be associated with these serious side effects:

2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:

3. Severe allergic reactions:

4. Abnormal bleeding: Fluoxetine oral solution 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. Seizures or convulsions

6. Manic episodes:

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

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

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

What is fluoxetine oral solution?

Fluoxetine oral solution 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 oral solution 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 oral solution treatment.

Who should not take fluoxetine oral solution?

Do not take fluoxetine oral solution if you:

People who take fluoxetine oral solution 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 oral solution? Ask if you are not sure.

Before starting fluoxetine oral solution, 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 oral solution 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 oral solution with your other medicines. Do not start or stop any medicine while taking fluoxetine oral solution without talking to your healthcare provider first.

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

  • Symbyax®
  • Sarafem®
  • Prozac® Weekly™

How should I take fluoxetine oral solution?

What should I avoid while taking fluoxetine oral solution?

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

What are the possible side effects of fluoxetine oral solution?

Fluoxetine oral solution may cause serious side effects, including:

Common possible side effects in people who take fluoxetine oral solution 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 oral solution. 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 oral solution?

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

General information about fluoxetine oral solution

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

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

What are the ingredients in fluoxetine oral solution?

Active ingredient: fluoxetine hydrochloride

Inactive ingredients: 0.23% alcohol, benzoic acid, spearmint flavor, glycerin, purified water, and sucrose.

Symbyax® and Sarafem® are registered trademarks of Eli Lilly and Company.

Prozac® Weekly™ is a trademark of Eli Lilly and Company.

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.

Zyprexa® is a registered trademark of Eli Lilly and Company.

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

Silarx Pharmaceuticals, Inc

Carmel,NY 10512 USA

Revised: 12/2013
 
Silarx Pharmaceuticals, Inc