Amisulpride 100mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Amisulpride

可用日期:

Teva UK Ltd

ATC代码:

N05AL05

INN（国际名称）:

Amisulpride

剂量:

100mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04020100; GTIN: 5017007373216

资料单张

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.
•
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
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.
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 are pregnant, might become pregnant or
are breast-feeding (see Pregnancy and
breastfeeding section)
•
If you have a prolactin dependent tumour or
breast cancer
•
If you have phaeochromocytoma (a tumour on
the adrenal gland)
•
If you are under 18 years of age.
•
If you are taking antiarrhythmic drugs for
controlling the heart rhyt

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
AMISULPRIDE 100mg TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100.000mg Amisulpride.
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, round tablets with a break line, diameter 9.5mm
and
impressed “C” and “AL” on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amisulpride is 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
POSOLOGY
For acute psychotic episodes, oral doses between 400 mg per day and
800 mg
per day are recommended. In individual cases, the daily dose may be
increased
up to 1200 mg per day. Doses above 1200 mg per 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.
Maintenance treatment should be established individually with the
minimally
effective dose.
For patients characterised by predominant negative symptoms, oral
doses
between 50 mg per day and 300 mg per 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 twice daily.
_Elderly _
Amisulpride should be used with particular caution because of a
possible risk
of hypotension or sedation.
Amisulpride should be used with particular caution because of a
possible risk
of hypotension and sedation. Reduction in dosage may al