Amisulpride 100mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Amisulpride

제공처:

Kent Pharma (UK) Ltd

ATC 코드:

N05AL05

INN (International Name):

Amisulpride

복용량:

100mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04020100

환자 정보 전단

4
1
Package Leaflet: Information for the User
SOLIAN
® 100MG TABLETS
AMISULPRIDE 100MG TABLETS
(amisulpride)
Your medicine is known by the above names, but will be referred to as
Solian
®
throughout this leaflet
This medicine is also available in other strengths.
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. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Solian
®
is and what it is used for
2. Before you take Solian
®
3. How to take Solian
®
4. Possible side effects
5. How to store Solian
®
6. Further Information
1. WHAT SOLIAN
® IS AND WHAT IT IS USED FOR
Solian
®
contains a medicine called amisulpride. This belongs to a group of
medicines called ‘anti-psychotics’. It is 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. Solian
®
works by
improving disturbed thoughts, feelings and behaviour. It is used to
treat
schizophrenia when it starts and also over the long term.
2. BEFORE YOU TAKE SOLIAN
®
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:

You are allergic (hypersensitive) to amisulpride or any of the other
ingredients of Solian
®
(listed in Section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.

You have breast cancer or something called ‘a prolactin dependent
tumour’.

You have a tumour on the adrenal gland (called phaeochromocytoma).

You are taking levodo

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 100mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg amisulpride.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, round, flat-faced tablet, engraved AMI 100 on one
side
and a breakline on the other side.
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
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 and sedation. Reduction in dosage may also be
required because
of renal insufficiency.
Children: The efficacy and safety of amisulpride from puberty to