SOLIAN amisulpride 100mg/mL oral solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amisulpride, Quantity: 100 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: methyl hydroxybenzoate; hydrochloric acid; propyl hydroxybenzoate; purified water; potassium sorbate; saccharin sodium; gluconolactone; sodium gluconate; Flavour

Administration route:

Oral

Units in package:

60mL

Prescription type:

(S4) Prescription Only Medicine

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:

Visual Identification: Clear yellow to yellow brown liquid with a characteristic caramel odour; Container Type: Bottle; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2004-02-12

Patient Information leaflet

SOLIAN
®
_amisulpride_
CONSUMER MEDICINE INFORMATION
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
(e.g. 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 TAMPERING OR THE
TABLETS DO NO

Summary of Product characteristics

solian-ccdsv15-piv20-25feb22
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION – SOLIAN (AMISULPRIDE)
TABLETS AND SOLUTION
1
NAME OF THE MEDICINE
Amisulpride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLETS
SOLIAN tablets contain amisulpride (100 mg, 200 mg and 400 mg).
Excipient with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
SOLUTION
SOLIAN solution contains amisulpride 100 mg/mL.
Excipients with known effect: hydroxybenzoates, saccharin and
sorbates.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TABLETS
SOLIAN 100: white to off white, flat-faced breakable tablet, engraved
“AMI 100”.
SOLIAN 200: white to off white, flat-faced breakable tablet, engraved
“AMI 200”.
SOLIAN 400: white, film-coated, breakable, oblong tablet, engraved
“AMI 400”.
SOLUTION
SOLIAN 100 mg/mL: a clear, yellow to yellow-brown coloured liquid.
solian-ccdsv15-piv20-25feb22
Page 2 of 20
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 according to individual
response.
Doses should preferably be administered before meals.
Amisulpride should be administered twice daily for doses above