Amisulpride 200mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Amisulpride

Saadav alates:

DE Pharmaceuticals

ATC kood:

N05AL05

INN (Rahvusvaheline Nimetus):

Amisulpride

Annus:

200mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04020100

Infovoldik

LOGO ACCORD
AMISULPRIDE 50MG, 100MG, AND 200MG TABLETS
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, PHARMACIST OR
NURSE.
•
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET: _ _
1.
WHAT AMISULPRIDE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE TABLETS
3.
HOW TO TAKE AMISULPRIDE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE AMISULPRIDE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT AMISULPRIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Amisulpride tablets
contain the active substance amisulpride which belong to a group of
medicines called benzamide
antipsychotics. These work by improving thoughts, feelings and/or
behaviour when these are disturbed
in certain medical conditions.
Amisulpride tablets may be used in the treatment of acute (severe or
sudden) and chronic (ongoing or
long-term) schizophrenia, a condition where certain symptoms become
very noticeable. These include
feeling, hearing or seeing things that aren’t really there
(hallucinations), having a strong false belief
despite evidence against it (delusions), inability to think normally,
and feeling emotional, disinterested
or withdrawn.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE TABLETS
DO NOT TAKE AMISULPRIDE TABLETS IF YOU:
•
are
BREASTFEEDING
•
are allergic to amisulpride or any of the other ingredients of this
medicine (listed in section 6) have
a
TUMOUR
that depends on prolactin (a hormone produced by the pituitary gland)
or
BREAST CANCER
•
have
PHAEOCHROMOCYTOMA
(a tumour of the adrenal gland causing high blood pressure)
�

Toote omadused

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