Amisulpride 200mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Amisulpride

Հասանելի է:

Sandoz Ltd

ATC կոդը:

N05AL05

INN (Միջազգային անվանումը):

Amisulpride

Դոզան:

200mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 04020100

Տեղեկատվական թերթիկ

Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4
Amisulpride contains the active substance
amisulpride. It belongs to a group of medicines called
antipsychotics.
Amisulpride is used to treat schizophrenia, when it
starts and also over the long term. Symptoms of this
illness include:
•
so called positive symptoms:- hallucinations, such as
feeling, seeing or hearing things which do not exist
-
strange and/or frightening thoughts
-
changes in your behaviour, which can be
aggressive
•
so called negative symptoms:
-
becoming withdrawn and subdued
Do not take Amisulpride if you are/have
•
allergic to amisulpride or any of the other
ingredients of this medicine (listed in section 6).
•
breast cancer or something called
“prolactin-dependent tumour”
•
a tumour on the adrenal gland
•
a child before the onset of puberty
•
taking levodopa: a medicine to treat Parkinson’s
disease
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Amisulpride if:
•
you are developing fever, faster breathing,
excessive sweating, reduced consciousness
or stiff muscles which are symptoms of a severe
– potentially fatal – disorder called “neuroleptic
malignant syndrome”. Stop immediately
taking Amisulpride and contact your doctor.
See also section 4, first paragraph
•
you have high blood sugar levels - diabetes
mellitus - or are at risk of developing it If you do,
your doctor may check your blood sugar levels
while you are taking Amisulpride.
•
you have kidney function disorder
See section “3 How to ta

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 200 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of amisulpride
_ _
Excipient with known effect
Each tablet contains 95.00 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, flat, 11 mm in diameter, with a score line. The tablet
can be divided
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amisulpride is indicated for the treatment of acute and chronic
schizophrenic
disorders with:
-
positive symptoms such as delusions, hallucinations, thought
disorders,
hostility, suspiciousness
-
negative symptoms (deficit syndrome) such as blunted affect, emotional
and social withdrawal.
This includes patients with predominant negative symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For acute psychotic episodes, oral doses between 400 mg/day and 800
mg/day
are recommended. In individual cases, the daily dose may be increased
up to
1200 mg. Doses above 1200 mg/day have not been extensively evaluated
for
safety and therefore should not be used. 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 in example
between
400-800mg/day.
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 can be administered once daily at oral doses up to 300 mg,
higher
doses should be administered bid.
The minimum effective dose and appropriate strength tablets should be
used.
Special populations
_Elderly (over 65 years):_ The safety of amisulpride has been examined
in a
limited number of elderly patients. Amis