Amisulpride 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amisulpride

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

N05AL05

INN (International Name):

Amisulpride

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
AMISULPRIDE 50MG, 100MG,
200MG AND 400MG TABLETS
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.
• Your doctor may have given you this
medicine before from another company. It
may have looked slightly different.
However, either brand will have the same
effect.
IN THIS LEAFLET:
1. What amisulpride is and what it is used
for
2. Before you take amisulpride
3. How to take amisulpride
4. Possible side effects
5. How to store amisulpride
6. Further information
1. WHAT AMISULPRIDE IS AND WHAT IT IS USED FOR
The name of your medicine is Amisulpride
50mg, 100mg, 200mg or 400mg Tablets
(called amisulpride throughout this leaflet).
This belongs to a group of medicines ‘anti-
psychotics’.
It is used to treat schizophrenia.
HOW AMISULPRIDE WORKS
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
works by improving disturbed thoughts,
feelings and behaviour.
2. BEFORE YOU TAKE AMISULPRIDE
DO NOT TAKE AMISULPRIDE AND TELL YOUR
DOCTOR IF:
X
You
are
allergic
(hypersensitive)
to
amisulpride or any of the other ingredients
of amisulpride (listed in Section 6 below).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
X
You are pregnant, might become pregnant
or are breast-feeding (see ‘Pregnancy and
breast-feeding’ section below).
X
You
have
breast
cancer
or
something
called ‘a prolactin dependent t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amisulpride 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg amisulpride.
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated oblong scored, engraved AMI 400.
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 the
age of 18 years
have not been established. Th