Amisulpride Thame 100mg/ml Sugar Free Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMISULPRIDE

Available from:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

ATC code:

N05AL05

INN (International Name):

AMISULPRIDE 100 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

AMISULPRIDE 100 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2019-03-27

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMISULPRIDE THAME 100MG/ML SUGAR FREE ORAL SOLUTION
(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. This
includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Amisulpride Thame 100mg/ml Sugar Free
Oral Solution but it
will be referred to as ‘Amisulpride’ throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Amisulpride is and what it is used for
2.
What you need to know before you take Amisulpride
3.
How to take Amisulpride
4.
Possible side effects
5.
How to store Amisulpride
6.
Contents of the pack and other information
1. WHAT AMISULPRIDE IS AND WHAT IT IS USED FOR
Amisulpride belongs to a group of medicines called
‘anti-psychotics’. It is used to treat an
illness called schizophrenia.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMISULPRIDE
DO NOT TAKE AMISULPRIDE IF:

you are allergic (hypersensitive) 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

you have a ‘prolactin dependent tumour’, for example breast cancer
or a pituitary gland
tumour

you have a tumour on the adrenal gland (called phaeochromocytoma)
which releases
hormones that cause high blood pressure

the patient is under 15 years old.

you are taking another medicine, when combined with Amisulpride is
contraindicated (see
‘Other medicines and Amisulpride’)
Do not take this medicine if any of the above apply to you. If you

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amisulpride Thame 100mg/ml Sugar Free Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is amisulpride.
Each ml of oral solution contains 100mg of amisulpride.
_Excipients with known effect:_
Each ml of oral solution contains 1.2mg methyl parahydroxybenzoate
(E218).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Solution
A clear, pale yellow colour solution with caramel odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amisulpride is indicated for the treatment of schizophrenic disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
As a general recommendation; Amisulpride can be administered once a
day at oral
doses up to 400 mg, higher dose should be split into two separate
doses
FOR ACUTE PSYCHOTIC EPISODES:
Oral doses between 4 ml/day (400 mg/day) and 8 ml/day (800
mg/day) are recommended. In individual cases, the daily dose may be
increased up to 12
ml/day (1200 mg/day). Doses above 12 ml/day (1200 mg/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.
Maintenance treatment should be established individually with the
minimally effective dose.
FOR PATIENTS CHARACTERISED BY PREDOMINANT NEGATIVE SYMPTOMS:
Oral doses between 0.5
ml/day (50 mg/day) and 3 ml/day (300 mg/day) are recommended. Doses
should be adjusted
individually.
The minimum effective dose should be used.
Page 2 of 12
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. There are limited data available on