Solian

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Amisulpride

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

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 TAMPERING

Summary of Product characteristics

 
Solian PI 

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CCDSv6 PIv11 9 Sep 13

PRODUCT INFORMATION 
SOLIAN
®
 TABLETS AND SOLUTION 
NAME OF THE MEDICINE 
SOLIAN 50 
SOLIAN 100 
SOLIAN 200 
SOLIAN 400 
SOLIAN SOLUTION 100mg/mL 
NON-PROPRIETARY NAME  

Amisulpride 
CHEMICAL STRUCTURE 

Chemical Name: 
(R, S)-4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-ethylsulfonyl-2-
methoxybenzamide 
Molecular Weight: 
369.48 
Molecular Formula: 
C
17
H
27
N
3
O
4
S 
CAS NUMBER 
71675-85-9 
DESCRIPTION 
Amisulpride  is  a  white  to  off-white  powder,  which  is  practically  insoluble  in  water,  sparingly 
soluble in ethanol, soluble in methanol and freely soluble
in dichloromethane. 
SOLIAN  Tablets  contain  amisulpride  (50  mg,  100  mg,  200  mg  and  400  mg)  and  the  following 
excipients: 

50, 100 and
200 mg tablets:   sodium  starch  glycollate  type  A,  lactose,  microcrystalline 
cellulose, hypromellose, magnesium stearate. 

400 mg tablets:  
sodium  starch  glycollate  type  A,  lactose,  microcrystalline 
cellulose,  hypromellose,  magnesium  stearate,  Peg-40 
stearate, titanium dioxide. 

Solian PI 

Page 2 
CCDSv6 PIv11 9 Sep 13

SOLIAN SOLUTION contains amisulpride 100mg/mL
and the following excipients: 

hydrochloric  acid,  methyl  hydroxybenzoate,  propyl 
hydroxybenzoate,  potassium  sorbate  and  purified 
water. 
and the following proprietary ingredients: 
Gesweet
® 
2023 (ARTG No 10553) 
 and Caramel Flavour

E9422058 (ARTG No 10645) 
PHARMACOLOGY 
CLASS 
Neuroleptic of the benzamide class  
PHARMACODYNAMICS 
Amisulpride  binds  selectively  to  the  human  dopaminergic  D
2
  (Ki  2.8  nM)  and  D
3
  (Ki  3.2  nM) 
receptor  subtypes  without  any  affinity  for  D
1
,  D
4
  and  D
5
  receptor  subtypes  (Ki  >  1 
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