Introducing a New Non-Hormonal Option to Treat Hot Flashes!

Brisdelle - Introducing a New Non-Hormonal Option to Treat Hot Flashes

If you are bothered by menopause, you are not alone. Millions of women suffer from hot flashes. And for some women, hot flashes can last for years.


Are you wishing for a prescription, non-hormonal treatment option? Your wish is granted with Brisdelle™ (paroxetine).*


* The safety and efficacy of Brisdelle™ compared with hormone therapies have not been studied. Brisdelle™ is a non-hormonal treatment option.

Talk to your doctor to see if Brisdelle™ may be right for you, and visit www.brisdelle.com to learn more.

In the meantime, here are the answers to some questions that you may have about Brisdelle™:

What is Brisdelle™?
Brisdelle™ is the first and only non-hormonal, FDA-approved treatment for moderate to severe hot flashes associated with menopause. Brisdelle™ is used to reduce moderate to severe hot flashes, so they are less frequent and less intense.

Brisdelle™ is proven safe and effective when used as directed. Brisdelle™ is a 7.5-mg capsule, taken once a day at bedtime.

How is Brisdelle™ different?
Brisdelle™ is the first and only non-hormonal, prescription medication used to treat moderate to severe hot flashes associated with menopause. Although it has the same ingredient as the antidepressant paroxetine, it is a lower dose that is not approved to treat depression or any other psychiatric condition. Brisdelle™ was specifically studied and FDA-approved to treat moderate to severe hot flashes associated with menopause.

How fast can Brisdelle™ start working?
On average, in clinical trials, Brisdelle™ started working 4 weeks after starting treatment. However, each patient may respond differently to treatment. If you have any questions about when Brisdelle™ may start working to treat your moderate to severe hot flashes associated with menopause, speak with your doctor.

How do I take Brisdelle™?
Brisdelle™ is 1 small capsule that is taken every night, just before bedtime. You can take it with or without food. If you have questions about taking Brisdelle™, talk to your doctor or pharmacist.

Who should not take Brisdelle™?
DO NOT take Brisdelle™ if you:
  • Take a Monoamine Oxidase Inhibitor (MAOI)
  • Take thioridazine or pimozide
  • Are allergic to paroxetine or any of the ingredients in Brisdelle™
  • Are pregnant

Please read the full Important Safety Information below for more information about who should not take Brisdelle™.

What are the common side effects?
The most common side effects of Brisdelle™ include headache, tiredness, nausea and vomiting. Of these commonly reported adverse reactions, nausea occurred primarily within the first 4 weeks of treatment and tiredness within the first week. Please read the full Important Safety Information, including Boxed WARNING on suicidal thoughts or actions, below for the complete list of serious side effects.

So if you’ve been suffering from moderate to severe hot flashes associated with menopause and you’re not treating your symptoms, or you haven’t found a treatment that’s right for you, talk to your doctor today about Brisdelle™.

Click here to SAVE on prescription Brisdelle™. Talk to your doctor today or visit www.brisdelle.com to learn more.

For eligible patients only. See offer for the full terms and conditions.

INDICATION

BRISDELLE™ (paroxetine) capsules is a prescription medicine used to reduce moderate to severe hot flashes associated with menopause.

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.

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

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

Suicidal thoughts or actions:
  • BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.
  • 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 BRISDELLE is started.

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 or go to the nearest emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you:
  • Attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent; thoughts about suicide or dying; new or worse depression; new or worse anxiety or panic attacks; feeling agitated, restless, angry, or irritable; trouble sleeping; an increase in activity or talking more than what is normal for you; other unusual changes in behavior or mood.

Serotonin Syndrome. This condition can be life-threatening and may include: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.

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

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.

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.

Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.

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.

Seizures or convulsions.

Restlessness: Women who take BRISDELLE may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking BRISDELLE.

Visual symptoms.

Who should not take BRISDELLE?

Do not take BRISDELLE if you:
  • Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 14 days of stopping BRISDELLE unless directed to do so by your healthcare provider.
  • Do not start BRISDELLE if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.
  • People who take BRISDELLE close in time to an MAOI may have serious or 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).
  • Take thioridazine or pimozide. Do not take thioridazine or pimozide together with BRISDELLE because this can cause serious heart problems or sudden death.
  • Are allergic to paroxetine or any of the ingredients in BRISDELLE.
  • Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn baby.

What should I tell my healthcare provider before starting BRISDELLE?

Before starting BRISDELLE, tell your healthcare provider if you:
  • Have liver or kidney problems; bipolar disorder or mania; low sodium levels in your blood; glaucoma (high pressure in the eye); have or had seizures, convulsions, or bleeding problems; have any other medical conditions; are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines such as migraine headache medication (triptans), other antidepressants and antipsychotics, vitamins, and herbal supplements.

If you take BRISDELLE, you should not take any other medicines that contain paroxetine, including Paxil®, Paxil CR®, and Pexeva®.

What should I avoid while taking BRISDELLE?

You should not drive, operate heavy machinery, or do other dangerous activities until you know how BRISDELLE affects you.

What are the most common side effects of BRISDELLE?

The most common possible side effects of BRISDELLE include: headache; tiredness; nausea and vomiting.

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.

Please read the Medication Guide within the full Prescribing Information before taking BRISDELLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for the full Prescribing Information, including Boxed Warning, and Medication Guide.

Brisdelle™, the Brisdelle Logo and the 3 Wings Design are trademarks of Noven Therapeutics, LLC.
Pexeva® is a registered trademark of Noven Therapeutics, LLC.
All other registered trademarks are the property of their respective owners.

© 2013-2014 Noven Therapeutics, LLC. All rights reserved.
For U.S. Audience Only. BRI-3519-13 2/14