Monitor liver function. Exercise caution before starting treatment & perform close surveillance throughout the treatment period in all patients, especially if hepatic injury risk factors (eg, obesity/overwt/non-alcoholic fatty liver disease, diabetes, alcohol use disorder &/or substantial alcohol intake) or concomitant medicinal products associated w/ risk of hepatic injury are present. Patients w/ pretreatment elevated transaminases (>ULN ranges & ≤3 times ULN range). Discontinue immediately if patient develops symptoms or signs of potential liver injury (eg, dark urine, light colored stools, yellow skin/eyes, pain in the upper right belly, sustained new-onset & unexplained fatigue); the increase in serum transaminases >3 times ULN. Patients w/ history of bipolar disorder, mania or hypomania & discontinue if patient develops manic symptoms. Increased risk of suicidal thoughts, self-harm & suicide (suicide-related events). Increased exposure in combination w/ moderate CYP1A2 inhibitors (eg, propranolol, enoxacin). Not to be taken by patients w/ galactose intolerance, total lactase deficiency, glucose-galactose malabsorption. May affect ability to drive & use machines. Severe or moderate renal impairment. Avoid use during pregnancy & lactation. Not recommended in childn <18 yr. Not to be used in elderly ≥75 yr or w/ dementia.
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