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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amisulpride Mylan 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amisulpride Mylan contains 400 mg amisulpride per tablet.
Excipient:
200 mg lactose monohydrate per film-coated tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, 18 x 8 mm capsule shaped, film coated tablet with break line on one side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amisulpride Mylan is indicated for the treatment of acute and chronic schizophrenic disorders:
•
Productive symptoms with delusions, hallucinations, thought disorders, hostility and suspicious behavior.
•
Primarily negative symptoms (deficit syndrome) with blunted affect, emotional and social withdrawal.
Amisulpride Mylan also controls secondary negative symptoms in productive conditions as well as affective disorders
such as depressive mood or retardation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For productive conditions, the recommended oral dose ranges from 400 to 800 mg/day. 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 Mylan. Doses should be adjusted according to
individual response. Maintenance treatment should be established individually with the minimally effective dose.
For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive
symptoms.
For patients characterized by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are
recommended. Doses should be adjusted individually.
Amisulpride Mylan may b
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