Amisulpride 100mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Amisulpride

Disponible des:

A A H Pharmaceuticals Ltd

Codi ATC:

N05AL05

Designació comuna internacional (DCI):

Amisulpride

Dosis:

100mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04020100; GTIN: 5025903000976

Informació per a l'usuari

Apotex Europe B.V.
UK/H/2350/01-04/DC
Amisulpride 50 mg, 100 mg, 200 mg and 400 mg tablets
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMISULPRIDE
50 MG TABLETS
100 MG TABLETS
200 MG TABLETS
400 MG FILM-COATED TABLETS
Amisulpride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. 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
The active ingredient in this medicine is 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. Amisulpride
works by improving
disturbed thoughts, feelings and behaviour. It is used to treat
schizophrenia when it starts and
also over the long term.
Apotex Europe B.V.
UK/H/2350/01-04/DC
Amisulpride 50 mg, 100 mg, 200 mg and 400 mg tablets
2
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE TABLETS
DO NOT TAKE AMISULPRIDE TABLETS:
•
You are allergic (hypersensitive) to amisulpride or any of the other
excipients of
Amisulpride (listed in Section 6). Signs of an allergic reaction
include: a rash,
swallowing

Fitxa tècnica

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