▪ Risperidone is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. ▪ Risperidone is indicated for the 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. ▪ Risperidone is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. ▪ Risperidone is indicated for the treatment of schizophrenia.
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Date of first authorisation/renewal of the authorisationĮach film-coated tablet contains 0.5 mg of risperidone.Įxcipient with known effect: Each film-coated tablet contains 63.65 mg lactose (as lactose monohydrate)Įach film-coated tablet contains 1 mg of risperidone.Įxcipient with known effect: Each film-coated tablet contains 127.30 mg lactose (as lactose monohydrate)Įach film-coated tablet contains 2 mg of risperidone.Įxcipients with known effect: Each film-coated tablet contains 126.35 mg lactose (as lactose monohydrate), and 0.02 mg of lake of sunset yellow (E 110)Įach film-coated tablet contains 3 mg of risperidone.Įxcipient with known effect: Each film-coated tablet contains 189.53 mg lactose (as lactose monohydrate)Įach film-coated tablet contains 4 mg of risperidone.Įxcipient with known effect: Each film-coated tablet contains 124.45 mg lactose (as lactose monohydrate)Įach film-coated tablet contains 6 mg of risperidone.Įxcipients with known effect: Each film-coated tablet contains 122.55 mg lactose (as lactose monohydrate) and 0.01 mg of lake of sunset yellow (E 110)įor the full list of excipients see section 6.1.
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