Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
RISPERIDONE
Pfizer Healthcare Ireland
4 Milligram
Film Coated Tablet
2011-07-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risperidone Pfizer 4 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 4 mg risperidone. Excipient: Each 4 mg film-coated tablet contains 236.00 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Green, biconvex, capsule-shaped tablets inscribed with ‘A’ on one side and ‘54’ on the other side. Scored between ‘5’ and ‘4’. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Risperidone Pfizer is indicated for the treatment of schizophrenia. Risperidone Pfizer is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone Pfizer 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 Pfizer 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 Přečtěte si celý dokument