Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
RISPERIDONE
WPR Healthcare Limited
N05AX08
RISPERIDONE
4 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Other antipsychotics
Authorised
2011-08-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rispatal 4 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4mg risperidone. Also contains lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets _Product imported from the UK:_ Green, round scored biconvex film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RISPERIDONE is indicated for the treatment of schizophrenia. RISPERIDONE is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. 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 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. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Schizophrenia _Adults_ RISPERIDONE may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the secon Lire le document complet