Amisulpride 200mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Amisulpride

Предлага се от:

Milpharm Ltd

АТС код:

N05AL05

INN (Международно Name):

Amisulpride

дозиране:

200mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04020100; GTIN: 5060035110797

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE
USER
AMISULPRIDE 50MG, 100MG,
200MG & 400MG TABLETS
amisulpride
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 or nurse. This includes
any possible side effects not listed in this
leaflet. see section 4.
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 belongs to a group of medicines
called ‘antipsychotics’.
The tablets are used to treat an illness called
schizophrenia. Schizophrenia can make you
feel, see or hear things which do not exist, have
strange and frightening thoughts, change how
you act, and make you feel alone. Sometimes
people with these symptoms may also feel
tense, anxious or depressed. Amisulpride
tablets work by improving disturbed thoughts,
feelings and behaviour. It is used to treat
schizophrenia when it starts and also over the
long term.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE AMISULPRIDE TABLETS
DO NOT TAKE AMISULPRIDE TABLETS:
•
If you are allergic to amisulpride or any of
the other ingredients of this medicine (listed
in section 6). Signs of an allergic reaction
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue.
•
If you have breast cancer or something
called ‘a prolactin dependent tumour’.
•
If you have a tumour on the adrenal gland
(called phaeochromocytoma).
•
If you are t

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Amisulpride
Excipient(s) with known effect
Each tablet contains 197.5 mg of lactose monohydrate.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white round tablets with break line on one side and
‘200’ on
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amisulpride 200mg Tablets are 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/d and 800 mg/d
are
recommended. In individual cases, the daily dose may be increased up
to 1200 mg/d.
Doses above 1200 mg/d 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.
Maintenance
treatment
should
be
established
individually
with
the
minimally
effective dose.
For patients characterised by predominant negative symptoms, oral
doses between 50
mg/d and 300 mg/d 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 should be used.
Elderly:_ _The safety of Amisulpride has been examined in a limited
number of elderly
patients. Amisulpride should be used with particular caution because
of a possible
risk of hypotension or sedation. Reduction in dosage may also be
required becaus