BRISDELLE- paroxetine capsule 
Noven Therapeutics, LLC

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MEDICATION GUIDE

BRISDELLE ® (bris-del)

(Paroxetine)

Capsules

Read the Medication Guide that comes with BRISDELLE 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. BRISDELLE contains a lower dose of paroxetine, a medicine also used to treat a number of psychiatric disorders. The lower dose of paroxetine in BRISDELLE has not been studied in any psychiatric conditions and BRISDELLE is not approved for any psychiatric uses.

What is the most important information I should know about BRISDELLE?

BRISDELLE may cause serious side effects.

Call your healthcare provider right away if you have any of the following symptoms, or go to the nearest emergency room:

1. Suicidal thoughts or actions:

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

3. Reduced effectiveness of tamoxifen. Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken while you take BRISDELLE. If you are taking tamoxifen, tell your healthcare provider before starting BRISDELLE.

4. Abnormal bleeding. BRISDELLE may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, 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. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this condition. Symptoms may include:

7. Bone Fractures. Women who take BRISDELLE may have a higher risk of bone fractures. Contact your healthcare provider if you have pain in a bone.

8. Manic episodes:

9. Seizures or convulsions.

10. Restlessness. Women who take BRISDELLE may feel an inner restlessness, agitation (nervousness), or be unable to sit still or stand still especially when they start taking BRISDELLE. Call your healthcare provider if this happens to you.

11. Driving. BRISDELLE may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how BRISDELLE affects you.

What is BRISDELLE?

BRISDELLE is a prescription medicine used to reduce moderate to severe hot flashes associated with menopause. BRISDELLE is a selective serotonin reuptake inhibitor (SSRI). It is not a hormone. The way BRISDELLE treats hot flashes associated with menopause is not known. BRISDELLE does not prevent or treat osteoporosis or dryness, itching or burning in and around the vagina.

BRISDELLE is not for psychiatric problems such as depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder.

BRISDELLE is not for use in children.

Talk to your healthcare provider if you do not think that your hot flashes are getting better while taking BRISDELLE.

Who should not take BRISDELLE?

Do not take BRISDELLE if you:

What should I tell my healthcare provider before taking BRISDELLE?

Before starting BRISDELLE, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRISDELLE and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.

If you take BRISDELLE, you should not take any other medicines that contain paroxetine,

including Paxil, Paxil CR and Pexeva.

Especially tell your healthcare provider if you take:

Ask your healthcare provider if you are not sure if you are taking any of these medications.

Your healthcare provider or pharmacist can tell you if it is safe to take BRISDELLE with your other medicines. Do not start or stop any medicine while taking BRISDELLE without talking to your healthcare provider first.

How should I take BRISDELLE?

What should I avoid while taking BRISDELLE?

What are the possible side effects of BRISDELLE?

BRISDELLE may cause serious side effects, including:

The most common side effects of BRISDELLE include:

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of BRISDELLE. 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 BRISDELLE?

General information about the safe and effective use of BRISDELLE.

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

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

For more information about BRISDELLE call 1-800-455-8070 or go to www.BRISDELLE.com.

What are the ingredients in BRISDELLE?

Active ingredient: paroxetine

Inactive ingredients: dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide, FD&C Yellow #6, FD&C Red #3, FD&C Red #40, shellac and black iron oxide.

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

Distributed by: Sebela Pharmaceuticals Inc. 645 Hembree Parkway, Suite I

Roswell, GA 30076

www.sebelapharma.com

BRISDELLE ® is a registered trademark of Sebela International Ltd.

© 2017 Sebela Pharmaceuticals Inc. All rights reserved.

Revised 03/2017

Revised: 4/2017
Noven Therapeutics, LLC