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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amisulpride Actavis 400mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400mg Amisulpride.
Excipients: Each tablet contains 200mg lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, ovoidal-shaped, biconvex, film-coated tablets with a break line, 18mm long and 8mm wide.
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, 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 per day and 800 mg per day are recommended. In individual
cases, the daily dose may be increased up to 1200 mg per day. Doses above 1200 mg per day have not been extensively
evaluated for safety and therefore should not be used. 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 per day and 300 mg per day
are recommended. Doses should be adjusted individually.
Amisulpride can be administered once daily at oral doses up to 300
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