Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
AMISULPRIDE
Winthrop Pharmaceuticals UK Limited
200 Milligram
Tablets
2004-10-29
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amisulpride 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amisulpride 200mg per tablet. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet White to off-white scored tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amisulpride 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 ADMINSTRATION 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 Amisulpride. 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 400mg. _Elderly:_ The safety of Amisulpride has been examined in a limited number of elderly patients. Amisulpride should be used with particular caution because of a possible risk of hypotension or sedation. Reduction in dosage may also be required because of renal insufficiency. _Children:_ Amisulpride is contra-indicated in children up to puberty as its safety has not yet been established. Olvassa el a teljes dokumentumot