PEXEVA - paroxetine mesylate tablet, film coated 
NOVEN THERAPEUTICS, LLC

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Medication Guide

PEXEVA® (pex-EE-va)
(paroxetine mesylate)


Read the Medication Guide that comes with PEXEVA® 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 PEXEVA®?

PEXEVA® and other antidepressant medicines may cause serious side effects, including:


1. Suicidal thoughts or actions:


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:

2. Serotonin Syndrome. This condition can be life-threatening and may include:

3. Visual problems

4. Severe allergic reactions:

5. Abnormal bleeding: PEXEVA® 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.

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:

What is PEXEVA®?

PEXEVA® 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.
PEXEVA® is also used to treat:


Talk to your healthcare provider if you do not think that your condition is getting better with PEXEVA® treatment.

Who should not take PEXEVA®?

Do not take PEXEVA® if you:


What should I tell my healthcare provider before taking PEXEVA®? Ask if you are not sure.

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

If you take PEXEVA®, you should not take any other medicines that contain paroxetine including:
PAXIL® and PAXIL CR®.

How should I take PEXEVA®?


What should I avoid while taking PEXEVA®?

PEXEVA® 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 PEXEVA® affects you. Do not drink alcohol while using PEXEVA®.

What are the possible side effects of PEXEVA®?

PEXEVA® may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about PEXEVA®?”

Common possible side effects in people who take PEXEVA® 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 PEXEVA®. 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 PEXEVA®?

Keep PEXEVA® and all medicines out of the reach of children.

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

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

For more information about PEXEVA® call (1‑800-455-8070) or go to www.PEXEVA.com.

What are the ingredients in PEXEVA®?

Active ingredient: paroxetine mesylate
Inactive ingredients: dibasic calcium phosphate, hydroxypropyl methylcellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycolate, titanium dioxide, and iron oxide(s)

Manufactured by:
Norwich Pharmaceuticals, Inc.
Norwich, NY 13815

Distributed by:
Noven Therapeutics, LLC,
11960 SW 144 St., Miami, FL 33186

Revised 07/2014

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

Revised: 07/2014
 
NOVEN THERAPEUTICS, LLC