Amisulpride 100mg/ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amisulpride

Available from:

Advanz Pharma

ATC code:

N05AL05

INN (International Name):

Amisulpride

Dosage:

100mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5060064791462

Summary of Product characteristics

OBJECT 1
AMISULPRIDE 100MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 14-Oct-2016 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
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 ora