Risperidon-BP

Risperidonum

Risperidon-BP 2 mg tablets: Each tablet contains risperidone 2 mg. Excipient with known effect: lactose monohydrate.

Risperidon-BP 4 mg tablets: Each tablet contains risperidone 4 mg. Excipient with known effect: lactose monohydrate.

Indication: ▪ Treatment of schizophrenia. ▪ Treatment of moderate to severe manic episodes associated with bipolar disorder. ▪ Short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. ▪ Short-term treatment (up to 6 weeks) of persistent aggression in children aged 5 years and above and adolescents with conduct disorder, with subaverage intellectual functioning or mental retardation diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), whose aggressiveness or destructive behaviour requires pharmacological treatment. Pharmacological treatment should be part of a comprehensive treatment programme, including psychological and educational support. Risperidone should be prescribed by a specialist in paediatric neurology and paediatric psychiatry, or by a physician experienced in treating behavioural disorders in children and adolescents.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Elderly patients with dementia. Increased mortality in elderly patients with dementia. In elderly patients with dementia treated with atypical antipsychotics, including risperidone, a meta-analysis of 17 clinical trials showed an increase in mortality compared with placebo. In placebo-controlled trials with oral risperidone, the mortality incidence in this category of patients was 4% compared with 3.1% in the placebo group. The relative risk (95% confidence interval) was 1.21 (0.7; 2.1). The mean age (age range) of patients who died was 86 years (range 67–100). Data from two large observational studies showed that elderly patients with dementia treated with conventional antipsychotics were […]