Not approved & not recommended for the treatment of dementia-related psychosis &/or behavioural disturbances. Not recommended in the treatment of dopamine agonist-associated psychosis in patients w/ Parkinson's disease. Discontinue treatment in case of signs & symptoms indicative of NMS or unexplained high fever w/o additional clinical manifestations of NMS. Observe patients for signs & symptoms of hyperglycaemia. Patients w/ DM or w/ risk factors for DM should be monitored regularly for worsening of glucose control. Regularly monitor wt. Risk of undesirable lipid alterations; transient, asymptomatic elevations of ALT &/or AST, especially in early treatment; VTE; tardive dyskinesia especially w/ long-term exposure; sudden cardiac death; DRESS. Caution in patients w/ prostatic hypertrophy, or paralytic ileus & related conditions; low leukocyte &/or neutrophil counts for any reason, history of drug-induced bone marrow depression/toxicity, bone marrow depression caused by concomitant illness, RT or chemotherapy, hypereosinophilic conditions or myeloproliferative disease; patients w/ history of seizures or are subject to factors which may lower the seizure threshold; renal &/or hepatic impairment; elderly ≥65 yr. Periodically measure BP in patients >65 yr. Acute symptoms eg, sweating, insomnia, tremor, anxiety, nausea, or vomiting w/ abrupt treatment discontinuation. Caution w/ concomitant medicines known to cause neutropenia; medicinal products known to increase QTc interval; other centrally acting medicines & alcohol; direct & indirect dopamine agonists. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Do not use if hypersensitive to peanut or soya. May affect ability to drive & use machines. Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal &/or w/drawal symptoms following delivery. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Do not breast-feed while on treatment. Not indicated/recommended in childn & adolescents <18 yr.