SOLIAN 100MG SCORED TABLET

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

AMISULPRIDE

可用日期:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN（国际名称）:

AMISULPRIDE

每包单位数:

30Tablet Tablets

厂商:

DELPHARM DIJON

资料单张

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_ Consumer Medication Information Leaflet (RiMUP) _
SOLIAN
® TABLET
_ _
Amisulpride (100mg, 400mg)
_ _
WHAT IS IN THIS LEAFLET
1. What Solian is used for
2. How Solian works
3. Before you use Solian
4. How to use Solian
5. While you are using it
6. Side effects
7. Storage and Disposal of Solian
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT SOLIAN IS USED FOR
Solian contains a medicine called
amisulpride.
This belongs to a group of medicines
called ‘antipsychotics’.
This medicine is used to treat people
with schizophrenia. Schizophrenia is a
mental illness characterized by various
mental and behavioral disorders, such
as hallucinations or agitation.
HOW SOLIAN WORKS
Solian works by improving disturbed
thoughts, feelings and behaviour. It is
used to treat schizophrenia when it
starts and also over the long term.
BEFORE YOU USE SOLIAN
_-When you must not use it _
Do not take Solian:

if you are allergic to the active
substance (amisulpride) or any of
the other ingredients of this
medicine. This is because this
medicine may have an effect on
your blood cells, i.e. reduce the
number of white blood cells. This
problem can be seen in a blood
test,

if you have a pheo
_chromocytoma_
(excessive growth of the adrenal
glands around the kidneys,
releasing substances which cause
high blood pressure),

in children under 15 years of age,

if you have a prolactin-dependent
tumor (prolactin is a hormone that
stimulates milk production), e.g.
breast cancer or pituitary
disorders,

if you are taking other medicines.
If this is the case, make sure that
combined use with Solian is not
contraindicated.
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist
before taking Solian.
_-Before you start to use it _
Talk to your doctor or pharmacist
before taking Solian.
Your doctor may ask you to have an
electrocardiogram (ECG) before
starting treatment. This medicine can
cause heart rhythm disor

产品特点

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QUALITATIVE AND QUANTITATIVE COMPOSITION
Solian ® 100 mg, scored tablets
Amisulpride …….……………………………1 00 mg
Solian ® 400 mg, scored film -coated tablets
Amisulpride ………………………………… 4 00 mg
PHARMACEUTICAL FORM
Solian ® 100 mg, scored tablets
White to off -white sco red tablet, engraved “AMI 100” .
Solian ® 400 mg, scored film -coated tablets
White scored film -coated tablet, engraved “AMI 400”.
CLINICAL PARTICULARS
Therapeutic indications
Treatment of acute or chronic schizophrenic disorders, in which positive symptoms (such as delusions,
hallucinations, thought disorders) and/or negative symptoms (such as blunted emotions , emotional and
social withdrawal) are pronounced , including patients with predominantly negative symptoms.
Posology and method of administration
Usu ally :
- if the daily dose is ≤ 400 mg, it is to be administered as a once -daily dose ;
- if the daily dose exceeds 400 mg, it is to be administered as two divided doses.
Predominantly negative episodes:
Doses between 50 mg/day and 300 mg/day are recommended. Doses should be adjusted individually.
The optimum dosage is about 100 mg/day.
Acute psychotic episodes
It is possible to start via the IM route for a few days, at a maximum dose of 400 mg/day, switching
thereafter to oral treatment,
Oral doses between 400mg/day and 800mg/day are recommended. The maximum dose should never
exceed 1200mg. Given that there has been no large -scale safety assessment of doses higher than
1200mg/day, these doses should not be used.
The dosage should be maintained or adjusted according to the patient's individual response.
In all cases, the maintenance treatment should be established individually with the minimum effective
dose.
Children and adolescents
The efficacy and safety of amisulpride from the age of puberty up to 18 years has not been elucidated :
available data on the use of amisulpride in adolescents with schizophrenia are limited. As a result,
amisulpride is not recommended in pa