资料单张
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
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产品特点
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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