AMISULPRIDE Tablets 400 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
AMISULPRIDE
Available from:
Winthrop Pharmaceuticals UK Limited
Dosage:
400 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2004-10-29
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amisulpride 400 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amisulpride 400mg per tablet.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film-Coated Tablet
White to off-white scored film-coated 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
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