SOLIAN 200 Milligram Tablets
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
06-06-2024
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
AMISULPRIDE
Inapatikana kutoka:
PCO Manufacturing
INN (Jina la Kimataifa):
AMISULPRIDE
Kipimo:
200 Milligram
Dawa fomu:
Tablets
Dawa ya aina:
Product subject to prescription which may be renewed (B)
Idhini hali ya:
Withdrawn
Idhini ya tarehe:
2013-12-31
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solian 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of amisulpride.
Excipient: Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from France:_
White to off-white, round, flat-faced breakable tablet, engraved 'AMI 200' on one side and with a breakable bar on the
other face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solian 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/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 Solian. 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 400 mg.
Elderly: The safety of Solian has been examined in a limited number of elderly patients. Solian should be used with
particular caution because o
Soma hati kamili
