Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.Tell your doctor about all your other medicines, especially:This list is not complete. It is generally believed (though not established in controlled trials) that use of an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.In premarketing testing of paroxetine, seizures occurred in 0.1% of paroxetine-treated patients. Discontinue treatment with BRISDELLLE if akathisia occurs.Brisdelle has the potential to impair judgment, thinking, or motor skills. Brisdelle contains a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. However, no Brisdelle dose adjustment is considered necessary in elderly patients SSRIs have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event No Brisdelle dose adjustment is considered necessary in patients with renal impairment No Brisdelle dose adjustment is considered necessary in patients with liver impairment There is limited clinical experience with Brisdelle overdosage in humans, as there were no overdoses reported in the clinical studies.Spontaneous cases of deliberate or accidental overdosage during paroxetine treatment have been reported; some of these cases were fatal and some of the fatalities appeared to involve paroxetine alone. You may report side effects to FDA at 1-800-FDA-1088.Using Brisdelle with other drugs that make you drowsy can worsen this effect. In managing overdosage, consider the possibility of multiple drug involvement.Brisdelle (paroxetine) is an orally administered selective serotonin reuptake inhibitor (SSRI) for the treatment of moderate to severe VMS associated with menopause. Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment. However, prior to initiating treatment with Brisdelle, all patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Do not use Brisdelle for a condition for which it was not prescribed. These are not all the possible side effects of Brisdelle. For more information, ask your healthcare provider or pharmacist.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Bleeding events related to SSRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms with other formulations of paroxetine.The following adverse reactions have been identified from clinical studies of paroxetine and during post-approval use of other formulations of paroxetine. Other drugs may interact with paroxetine, including prescription and over-the-counter medicines, Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Brisdelle only for the indication prescribed.Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.Copyright 1996-2020 Cerner Multum, Inc. It is identified chemically as (-)- The mesylate salt of paroxetine is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/mL in water.Each pink capsule contains 9.69 mg paroxetine mesylate equivalent to 7.5 mg paroxetine base.Inactive ingredients consist of: 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.Nonclinical studies have shown that paroxetine is an SSRI. Advise families and caregivers of the need for close observation and communication with the prescriber All patients being treated with Brisdelle should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment.Families and caregivers of patients being treated with Brisdelle should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers.Discontinue Brisdelle and any concomitant serotonergic agents immediately if the above events occur and initiate supportive symptomatic treatment.The pupillary dilation that occurs following use of many antidepressants and Brisdelle may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.General disorders and administration site conditionsGeneral Disorders and Administration Site ConditionsDrugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)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:Brisdelle, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.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:2.