Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
RISPERIDONE
B & S Healthcare
N05AX08
RISPERIDONE
2 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Other antipsychotics
Authorised
2009-11-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risperdal 2mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2mg risperidone. Excipients: Also contains lactose and orange yellow S (E110). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product sourced from Italy:_ Pale orange, oblong, film-coated tablets marked Ris/2 on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RISPERDAL is indicated for the treatment of schizophrenia. RISPERDAL is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. RISPERDAL 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. RISPERDAL 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_ RISPERDAL may be given once daily or twice daily. Patients should start with 2 m Read the complete document