SOLIAN TABLET 100 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AMISULPRIDE

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

N05AL05

Dosage:

100 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

AMISULPRIDE 100 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

DELPHARM DIJON

Authorization status:

ACTIVE

Authorization date:

2001-03-01

Patient Information leaflet

SOLIAN
®
 100MG, 200MG AND 400MG 
Amisulpride Scored Tablets 

[Sanofi logo] 

COMPOSITION 
Solian 100 mg scored tablet 
Amisulpride ……….…………………………….…….......
100 mg, 
Solian 200 mg scored tablet 
Amisulpride ……….…………………………….…….......
200 mg, 
Solian 400 mg scored tablet 
Amisulpride ……….…………………………….…….......
400 mg 

PHARMACEUTICAL FORM 
Solian 100 mg scored tablet: 
White to off-white scored tablet engraved “AMI 100”. 
Solian 200 mg scored tablet: 
White to off-white scored tablet engraved “AMI 200”. 
Solian 400 mg scored film-coated tablet: 
White scored film-coated tablet engraved “AMI 400”. 

CLINICAL PARTICULARS 

THERAPEUTIC INDICATIONS 

Treatment of
schizophrenia, particularly acute or chronic schizophrenic 
disorders, characterised by positive symptoms (e.g.
delirium, hallucinations, 
thought disorders) and/or
negative symptoms (e.g. blunted emotions, emotional 
and social withdrawal), including when the negative
symptoms predominate.  

DOSAGE AND ADMINISTRATION 

Usually, if the daily dose is ≤ 400 mg, it will be
administered as a once-daily 
intake. If the daily dose exceeds 400 mg, it will be
administered as two daily 
intakes. 

_Predominantly negative episodes _
The recommended dosage is 50 to 300
mg/day. Dosage should be adjusted on 
an individual basis. The optimum dosage is about 100 mg/day. 

_Mixed episodes with positive and negative symptoms _
At the beginning of treatment, the dosage should be that which
enables the 
control of positive symptoms, i.e. 400 to 800 mg/day. The dosage
should then 
be adjusted individually as a function of the
patient's response, so as to obtain 
the minimum effective dose. 

_Acute psychotic episodes _
At the beginning of treatment: 
•  it is possible to start via th

Summary of Product characteristics

SG/SOL100, 200, 400/0822/SmPC0821
SOLIAN
® 100MG, 200MG AND 400MG
Amisulpride Scored Tablets
COMPOSITION
Solian 100 mg scored tablet
Amisulpride ……….…………………………….…….......
100 mg,
Solian 200 mg scored tablet
Amisulpride ……….…………………………….…….......
200 mg,
Solian 400 mg scored tablet
Amisulpride ……….…………………………….…….......
400 mg
PHARMACEUTICAL FORM
Solian 100 mg scored tablet:
White to off-white scored tablet engraved “AMI 100”.
Solian 200 mg scored tablet:
White to off-white scored tablet engraved “AMI 200”.
Solian 400 mg scored film-coated tablet:
White scored film-coated tablet engraved “AMI 400”.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of schizophrenia, particularly acute or chronic
schizophrenic disorders, characterised by positive symptoms (e.g.
delirium, hallucinations, thought disorders)
and/or negative symptoms (e.g. blunted emotions, emotional and social
withdrawal), including when the negative symptoms predominate.
DOSAGE AND ADMINISTRATION
Usually, if the daily dose is ≤ 400 mg, it will be administered as a
once-daily intake. If the daily dose exceeds 400 mg, it will be
administered as two daily intakes.
_Predominantly negative episodes _
The recommended dosage is 50 to 300 mg/day. Dosage should be adjusted
on an individual basis. The optimum dosage is about 100 mg/day.
_Mixed episodes with positive and negative symptoms _
At the beginning of treatment, the dosage should be that which enables
the control of positive symptoms, i.e. 400 to 800 mg/day. The dosage
should then be adjusted
individually as a function of the patient's response, so as to obtain
the minimum effective dose.
_Acute psychotic episodes _
At the beginning of treatment:
•
it is possible to start via the IM route for a few days, at a maximum
dose of 400 mg/day, replaced thereafter with oral treatment,
•
the recommended dosage via the oral route is 400 to 800 mg; the
maximum dosage should never exceed 1 200 mg.
T