AMISULPRIDE

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

AMISULPRIDE

Disponible des:

Focus Pharmaceuticals Ltd

Codi ATC:

N05AL05

Designació comuna internacional (DCI):

AMISULPRIDE

Dosis:

100 Mg/Ml

formulario farmacéutico:

Oral Solution

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

amisulpride

Estat d'Autorització:

Not Marketed

Data d'autorització:

2011-06-03

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMISULPRIDE 100MG/ML ORAL SOLUTION
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. 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 Amisulpride Oral Solution is and what it is used for
2. Before you take Amisulpride Oral Solution
3. How to take Amisulpride Oral Solution
4. Possible side effects
5. How to store Amisulpride Oral Solution
6. Further information
1. WHAT AMISULPRIDE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Your medicine is called Amisulpride 100mg/ml Oral Solution (called
Amisulpride Oral
Solution throughout this leaflet).
WHAT THIS MEDICINE DOES
Amisulpride Oral Solution is one of a group of medicines called
neuroleptics. These
are used to treat acute and chronic schizophrenia. Symptoms of this
condition can
include sensing, seeing or hearing things that do not exist, becoming
withdrawn and
having mistaken beliefs or suspicions.
2. BEFORE YOU TAKE AMISULPRIDE ORAL SOLUTION
DO NOT TAKE AMISULPRIDE ORAL SOLUTION

if you are allergic (hypersensitive) to amisulpride or any of the
other ingredients of
Amisulpride Oral Solution (see section 6, FURTHER INFORMATION);

if you have a tumour of the pituitary gland or breast cancer;

if you have phaeochromocytoma (a tumour of the adrenal gland);

if you are under 18 years of age;

if you are breast-feeding;

if you are taking a dopamine agonist e.g. levodopa used in
Parkinson’s disease,
bromocriptine used in pituitary problems and ropinirole used in
restless leg
syndrome.
2
TALK TO YOUR DOCTOR OR PHARMACIST IF ANY OF THE FOLLOWING APPLY TO
YOU:

if you suffer from kidney problems;

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amisulpride 100mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 100mg of Amisulpride.
It also contains 1mg/ml methyl parahydroxybenzoate (E218), 0.5mg/ml
propyl parahydroxybenzoate (E216), sodium
(4.02mg/ml) and ethanol (less than 0.5mg/ml)
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
A colourless to brown yellowish clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amisulpride Oral Solution 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/day and 800
mg/day are recommended.
In individual cases,
the daily dose may be increased up to 1200 mg/day. Doses above 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
Oral Solution.
Doses should be adjusted according to individual response.
Maintenance treatment should be
established individually with the minimally effective dose.
FOR PATIENTS WITH MIXED POSITIVE AND NEGATIVE SYMPTOMS, doses should
be adjusted to obtain optimal control of
positive symptoms i.e. between 400-800 mg/day.
Maintenance treatment should be established individually with the
minimally effective dose.
FOR PATIENTS CHARACTERISED BY PREDOMINANT NEGATIVE SYMPTOMS, oral
doses between 50 mg/day and 300 mg/day are
recommended.
Doses should be adjusted individually.
Amisulpride Oral Solution can be administered once daily at oral doses
up to 300 mg, higher doses should be
administered in two separate doses.
The minimum effective dose should be used.
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