Moderate to severe VMS affect approximately 24 million menopausal women in the United States. Many women have hot flashes on a daily basis, some as frequently as every hour, whereas others experience these symptoms only weekly or monthly. Some women have hot flashes and night sweats for more than five years.
Hot flashes can interfere with daily personal and professional relationships and activities. They can also be very bothersome, causing discomfort, embarrassment and disruption of sleep.
To learn more about Brisdelle™, and for the full Prescribing Information, including the Medication Guide, visit www.Brisdelle.com and read the Important Safety Information, including the Boxed Warning, on pages two through four below.
About the expert:
Dr. David Portman, Director of the Columbus Center for Women's Health Research
Dr. Portman founded the Columbus Center for Womens Health Research in 1997 and has conducted over 100 clinical studies in hormone therapy, osteoporosis, contraception, female sexual health and other issues pertaining to OB/GYN. Dr. Portman is recognized as one of the countrys leading experts in menopause and the treatment options available to women today.
* David Portman, M.D., is a compensated consultant for Noven Pharmaceuticals, Inc. Statements made by Dr. Portman are his own opinions.
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:
o New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
o 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.
Serotonin Syndrome: 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.
Who should not take BRISDELLE?
Do not take BRISDELLE if you:
· Take a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid. Unless directed to do so by your physician, do not take an MAOI within 14 days of stopping BRISDELLE and do not start BRISDELLE if you stopped taking an MAOI in the last 14 days. People who take BRISDELLE close in time to an MAOI may have serious or life-threatening side effects.
· Take thioridazine or pimozide. Do not take thioridazine or pimozide together with BRISDELLE because this can cause serious heart problems or sudden death.
· 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.
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.
To learn more about Brisdelle™ and for the full Prescribing Information, including the
Medication Guide, visit www.Brisdelle.com. Please read the Medication Guide within the full Prescribing Information before taking BRISDELLE. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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