국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
AMISULPRIDE
PCO Manufacturing
200 Milligram
Tablets
2006-11-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solian 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg of amisulpride. Excipient: Lactose monohydrate For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from France:_ White to off-white, round, flat-faced breakable tablet, engraved 'AMI 200' on one side and with a breakable bar on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solian is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For acute psychotic episodes, oral doses between 400 mg/day and 800 mg/day are recommended. Doses above 800 mg/day have not been associated with greater efficacy and have induced higher rates of extrapyramidal symptoms. No specific titration is required when initiating the treatment with Solian. Doses should be adjusted according to individual response. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterised by predominant negative symptoms, oral doses between 50 mg/day and 300 mg/day are recommended. Doses should be adjusted individually. Amisulpride should be administered b.i.d. for doses above 400 mg. Elderly: The safety of Solian has been examined in a limited number of elderly patients. Solian should be used with particular caution because of a 전체 문서 읽기