NON-HORMONAL
Treat hot flashes with non-hormonal Brisdelle®. Brisdelle is the only non-hormonal medication that’s FDA-approved as safe and effective to reduce moderate to severe hot flashes during menopause — so they’re fewer and less severe.
FDA-APPROVED
Safe and effective for relief of hot flashes, when used as directed.
RELIEF AT 4 WEEKS
It is important to give Brisdelle a full 4 week trial period to determine if Brisdelle is right for you. Everyone will respond differently, so if you have any questions about when Brisdelle might start working, please talk to your doctor.
Hot tip about hot flashes & hot flash medication
Hot tip about hot flashes & hot flash medication
Did you hear the medical information published in April 2015 about menopause? The results of this national, multi-centered study showed that the majority of women had hot flashes that lasted for over 7 years.*
If your hot flashes are bothering you, talk with your doctor about getting relief with Brisdelle.
Brisdelle is the only FDA-approved non-hormonal for moderate to severe hot flashes associated with menopause.
WHY CHOOSE A NON-HORMONAL MEDICINE THAT'S FDA APPROVED?
Until Brisdelle was available, the only FDA-approved treatment options for hot flashes were hormone therapies. That limited your choices.
With Brisdelle, you can do something different. Brisdelle is the only non-hormonal prescription medication proven to reduce moderate to severe hot flashes during menopause — so they are less frequent and less intense. And the nightly dose provides 24-hour relief.
WHAT MAKES BRISDELLE® DIFFERENT FROM OVER-THE-COUNTER, HERBAL SUPPLEMENTS FOR HOT FLASHES?
For starters, the FDA has not approved any over-the-counter products as being safe and effective to treat hot flashes. So, herbal supplements — such as black cohosh or soy — are not FDA-approved as safe and effective medicines; nor do the medical experts of the North American Menopause Society recommend them†. Matter of fact, up until 2013, the only FDA-approved treatment options for hot flashes were prescription hormone therapies.
But with Brisdelle, you have a choice of treatment options since Brisdelle is the only non-hormonal prescription medicine that was both specifically designed and proven to reduce moderate to severe hot flashes due to menopause.
HOT FLASHES: HOW BAD ARE THEY?
Hot flashes — that feeling when you’re suddenly overheating and sweating — are annoying and uncomfortable. Yet each of us deals with hot flashes differently. So, it’s important to talk to your doctor about hot flashes.
Hot flashes are sudden feelings of intense heat in the body, that are experienced by 3 out of 4 women during menopause*.
Moderate hot flashes cause a sensation of heat with sweating, but you are able to continue activity.
Severe hot flashes cause a sensation of heat with sweating, and cause you to stop activity.
Brisdelle® is proven to reduce hot flashes — both the number and their severity — during menopause.
†Results of the North American study published in 2015 by The North American Menopause Society.
*Results of a nationwide study published in 2015 by the Journal of the American Medical Association.
What is Brisdelle?
What is Brisdelle?
- Non-hormonal: The only non-hormonal prescription treatment proven to reduce moderate to severe hot flashes during menopause — so they are less frequent and less intense.
- FDA-approved: Brisdelle was proven safe and effective when used as directed, in well-controlled clinical trials with more than 1,100 menopausal women suffering from moderate to severe hot flashes.
- Taken once each night: Just one 7.5 mg capsule taken at bedtime with or without food provides 24-hour relief.
HOW SOON WILL BRISDELLE® WORK?
It’s important to give Brisdelle a full 4-week trial period to determine whether or not it may be right for you. In clinical trials, Brisdelle was first evaluated at week 4 and was shown to provide relief from moderate to severe hot flashes so they are less frequent and less intense.
Everyone’s body is different and responds to medicine differently. So give prescription Brisdelle time and take it the way your doctor prescribed. If you have questions about when Brisdelle might start working, please talk with your doctor.
IS BRISDELLE® AN ANTIDEPRESSANT?
Brisdelle is in a class of medicines that are called selective serotonin reuptake inhibitors (SSRIs). FDA approved Brisdelle for one thing only: to treat moderate to severe hot flashes due to menopause. No other SSRI is approved to treat moderate to severe hot flashes. Other SSRIs, however, are approved by the FDA to treat depression and some psychiatric conditions. Brisdelle is not.
WILL BRISDELLE® GET RID OF MY HOT FLASHES COMPLETELY?
Brisdelle may not completely get rid of hot flashes, but it should reduce the frequency and severity of them. While some patients may start to have relief sooner, it is important to give Brisdelle a full 4-week trial. During clinical trials, women taking Brisdelle were first evaluated at the end of 4 weeks. That was when women taking Brisdelle had significant relief in reducing both the frequency and severity of moderate to severe hot flashes.
How do I treat moderate to severe
menopausal hot flashes?
How do I treat moderate to severe menopausal hot flashes?
Brisdelle is a capsule you take every night at bedtime, to treat your moderate to severe hot flashes due to menopause. You can take it with or without food. Each dose gives relief from hot flashes for 24 hours. Brisdelle® is safe and effective when you continue taking it as your doctor prescribed.
In clinical studies, Brisdelle was first evaluated at 4 weeks. You should give Brisdelle treatment that long before talking with your doctor about your results.
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.
WHAT ARE THE MOST COMMON SIDE EFFECTS FOR BRISDELLE?
- Headache
- Tiredness
- Nausea
- Vomiting
Of these commonly reported reactions, nausea occurred primarily within the first 4 weeks of treatment and tiredness within the first week. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of Brisdelle. Please see full important safety information, including Boxed WARNING on suicidal thoughts or actions, for a complete list of serious side effects and other important safety information.
Support You Could Use
Get the help you deserve, from community resources to financial support, make the connection here.
What to Expect
Understanding menopause can help you feel more in control, so start today.
Co-pay Savings
Pay as little as $25 for each monthly prescription for Brisdelle. For eligibility and to register, begin here.
Co-pay Savings
Pay as little as $25 for each monthly prescription for Brisdelle. For eligibility and to register, begin here.
What to Expect
Understanding menopause can help you feel more in control, so start today.
Support You Could Use
Get the help you deserve, from community resources to financial support, make the connection here.
For any questions about Brisdelle
Call: 888-246-1207
For any questions about Brisdelle
call: 888-246-1207
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 or 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.
Visual symptoms.
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.
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.
INDICATION
BRISDELLE® (paroxetine) capsules is a prescription medicine used to reduce moderate to severe hot flashes associated with menopause.
BRISDELLE is not approved to treat depression or any other psychiatric conditions.
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
www.fda.gov/medwatch or call
1-800-FDA-1088.
Brisdelle® and Pexeva® are registered trademarks of Sebela International Ltd. All other registered trademarks are the property of their respective owners.
Brisdelle®, the Brisdelle Logo, the 3 Wings Design, and My Brisdelle® are registered trademarks of Sebela International Ltd. All other registered trademarks are the property of their respective owners.
All rights reserved. For U.S. Audience Only. BRI-907-0916H
© 2016 Sebela Pharmaceuticals Inc.
© 2016 Sebela Pharmaceuticals Inc.
Important Safety Information
What is the most important information I should know about BRISDELLE (paroxetine)?
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 or 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.
Visual symptoms.
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.
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 lifethreatening 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.
INDICATION
BRISDELLE® (paroxetine) capsules is a prescription medicine used to reduce moderate to severe hot flashes associated with menopause.
BRISDELLE is not approved to treat depression or any other psychiatric conditions.
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.
Brisdelle® and Pexeva® are registered trademarks of Sebela International Ltd. All other registered trademarks are the property of their respective owners.
