Perform liver function tests (LFT) before starting treatment & then after around 3 wk, 6 wk (end of acute phase), 12 wk & 24 wk (end of maintenance phase) & thereafter when clinically indicated; do not initiate in patients w/ transaminases >3 x ULN. Perform LFT w/ the same frequency as in initiating treatment when increasing the dosage. Cases of liver injury, including hepatic failure (few cases were exceptionally reported w/ fatal outcome or liver transplantation in patients w/ hepatic risk factors), elevations of liver enzymes >10 x ULN, hepatitis & jaundice. Patients w/ hepatic injury risk factors (eg, obesity/overwt/non-alcoholic fatty liver disease, diabetes, substantial alcohol intake); concomitantly receiving medicines associated w/ risk of hepatic injury; w/ pretreatment elevated transaminases (> & ≤3 x ULN). Discontinue immediately if patient develops signs or symptoms of potential liver injury (eg, dark urine, light coloured stools, yellow skin/eyes, pain in the upper right abdomen, sustained new-onset & unexplained fatigue) & increased serum transaminases >3 x ULN. Discontinue if manic symptoms develop in patients w/ history of bipolar disorder, mania or hypomania. Depression associated w/ increased risk of suicidal thoughts, self harm & suicide (suicide-related events); closely monitor until improvement occurs; increased risk of suicide in the early stages of recovery; carefully monitor patients w/ history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement due to greater risk of suicidal thoughts or attempts; monitor for any clinical worsening, suicidal behaviour or thoughts, & unusual behavioural changes. Increased exposure w/ moderate CYP1A2 inhibitors (eg, propranolol, enoxacin). Contains lactose; not for patients w/ rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Renal impairment. Avoid use during pregnancy. Lactation. Not recommended in childn <18 yr. Not for major depressive episodes in the elderly w/ dementia.