Source: HPRA (Health Products Regulatory Authority)
Teva Pharma B.V.
License Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Amisulpride Teva 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg amisulpride. Excipients Each tablet contains 60.2 mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White to almost white, flat, round tablet, debossed “MS 100” on one side with a scoreline on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders with: positive symptoms such as delusions, hallucinations, thought disorders, hosility, suspiciousness primary negative symptoms (deficit syndrome) such as blunted affect, emotional and social withdrawal. 4.2 Posology and method of administration Positive symptoms The recommended dose is 400-800 mg amisulpride daily. In individual cases, the daily dose may be increased to 1,200 mg amisulpride. Doses above 1,200 mg/day have not been sufficiently evaluated for safety and therefore should not be used. Amisulpride can be administered once daily at oral doses up to 300 mg, higher doses should be administered in divided doses. No specific Read the complete document