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.
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:
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:
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.
Who should not take BRISDELLE? Do not take BRISDELLE if you:
What should I tell my healthcare provider before starting BRISDELLE?
Before starting BRISDELLE, tell your healthcare provider if you:
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 www.fda.gov/medwatch or call 1-800-FDA-1088.
Brisdelle® and Pexeva® are registered trademarks of Noven Therapeutics, LLC.All other registered trademarks are the property of their respective owners