Solian

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Amisulpride 100 mg/mL;  

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Amisulpride 100 mg/mL

Dosage:

100 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Amisulpride 100 mg/mL   Excipient: Caramel Hydrochloric acid Methyl hydroxybenzoate Potassium sorbate Propyl hydroxybenzoate Purified water Sweetener Gesweet 01002023

Units in package:

Bottle, glass, + graduated dose syringe, child proof cap, 60 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

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.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, + graduated dose syringe, child proof cap - 60 mL - 36 months from date of manufacture stored at or below 25°C 2 months opened stored at or below 25°C

Authorization date:

2003-02-27

Patient Information leaflet

SOLIAN
®
1
SOLIAN
®
_amisulpride _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
answers to some common questions
about this medicine. It does not
contain all the available information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Solian against
the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT SOLIAN IS USED
FOR
The name of your medicine is Solian.
It contains the active ingredient
called amisulpride.
Solian belongs to a group of
medicines called antipsychotics.
Solian is used to treat symptoms of
schizophrenia.
Schizophrenia is a condition which
affects the way you think, feel and/or
act. Schizophrenia may cause
symptoms such as hallucinations (eg
hearing, seeing or sensing things
which are not there), delusions,
unusual suspiciousness, emotional
and social withdrawal. People with
schizophrenia may also feel
depressed, anxious or tense.
Your doctor may have prescribed
Solian for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SOLIAN HAS
BEEN PRESCRIBED FOR YOU.
BEFORE TAKING IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SOLIAN IF:
•
YOU HAVE AN ALLERGIC
REACTION TO SOLIAN OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Signs of an allergic reaction may
include a skin rash, itching,
shortness of breath or swelling of
the face, lips or tongue.
•
YOU ARE BREASTFEEDING OR PLAN TO
BREASTFEED.
•
YOU ARE TAKING THE FOLLOWING
MEDICINES
−
medicines used to treat irregular
heart rhythm such as quinidine,
disopyramide, amiodarone and
sotalol
−
cisapride
−
antibiotics such as erythromycin
and pentamidine, given as an
injection into the veins
−
levodopa, a medicine used in
Parkinson's disease
−
thioridazone, an antipsychotic
−
methadone, medicine used to treat
pain or addiction
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF T

Summary of Product characteristics

solian-ccdsv14-dsv17-27nov20
Page 1
DATA SHEET
1 PRODUCT NAME
SOLIAN 50 50mg Tablets*
SOLIAN 100 100mg Tablets*
SOLIAN 200 200mg Tablets*
SOLIAN 400 400mg Tablets*
SOLIAN 100mg/mL Solution, oral
*Not marketed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SOLIAN 50 50mg Tablets*: Each tablet contains 50mg of amisulpride
SOLIAN 100 100mg Tablets*: Each tablet contains 100g of amisulpride
SOLIAN 200 200mg Tablets*: Each tablet contains 200mg of amisulpride
SOLIAN 400 400mg Tablets*: Each tablet contains 400mg of amisulpride
SOLIAN 100mg/mL Solution, oral: Each mL contains 100mg of amisulpride
For the full list of excipients, see Section 6.1.
*Not marketed
3 PHARMACEUTICAL FORM
SOLIAN 50* white to off white, flat-faced breakable tablet, engraved
“AMI 50”.
SOLIAN 100* white to off white, flat-faced breakable tablet, engraved
“AMI 100”.
solian-ccdsv14-dsv17-27nov20
Page 2
SOLIAN 200* white to off white, flat-faced breakable tablet, engraved
“AMI 200”.
SOLIAN 400* white, film-coated, breakable, oblong tablet, engraved
“AMI 400”.
SOLIAN SOLUTION 100mg/mL a clear, yellow to yellowish coloured liquid
*Not marketed
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 DOSE 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. Doses above 800
mg/d have not been shown to be superior to lower doses and may
increase the incidence of
adverse events. No specific titration is required when initiating the
treatment with amisulpride.
Doses should be adjusted