Epilim

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Kjøp det nå

Last ned Preparatomtale (SPC)
12-06-2024

Aktiv ingrediens:

Sodium valproate

Tilgjengelig fra:

Sanofi-Aventis Australia Pty Ltd

Klasse:

Medicine Registered

Informasjon til brukeren

                                EPILIM
®
 
_Sodium Valproate_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Epilim.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your taking Epilim
against the benefits they expect it
will have for you.
PLEASE READ THIS LEAFLET VERY
CAREFULLY BEFORE YOU START TO TAKE
YOUR EPILIM, EVEN IF YOU HAVE
TAKEN EPILIM BEFORE.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT EPILIM IS USED
FOR
Epilim is a medicine used to for the
treatment of epilepsy in adults and
children.
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different types of seizures,
ranging from mild to severe.
Epilim belongs to a group of
medicines called anticonvulsants.
These medicines are thought to work
by controlling brain chemicals which
send signals to nerves so that seizures
do not happen.
Epilim may also be used to control
mania, a mental condition with
episodes of overactivity, elation or
irritability.
Epilim may be used alone or in
combination with other medicines to
treat your condition.
Your doctor, however, may have
prescribed Epilim for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
There is no evidence that Epilim is
addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE IT IF YOU HAVE OR HAVE
HAD ANY OF THE FOLLOWING MEDICAL
CONDITIONS:
•
liver disease (hepatic
dysfunction) or severe hepatitis.
•
a family history of hepatitis,
especially when caused by
medicines. Medicines used in the
treatment of epilepsy, including
Epilim may have adverse effects
on the liver and the kidneys.
•
a urea cycle disorder or a family
history of urea cycle disorders.

                                
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Preparatomtale

                                 
 
Epilim Oral PI 
CCDSv14 PIv8 2 Oct 12
 
Page 1  
 
PRODUCT INFORMATION 
EPILIM
®
 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Sodium valproate 
CHEMICAL NAME 
Sodium di-n-propylacetic acid  
CHEMICAL STRUCTURE 
 
 
 
 
 
 
 
 
 
 
 
CAS REGISTRY NUMBER 
1069-66-5 
DESCRIPTION 
_Active_:  
Sodium valproate.  Sodium valproate is a white, odourless, crystalline powder with a saline 
taste.  It is highly soluble in water and alcohol. 
 Its molecular weight is 166.  It is quite dissimilar 
to other established anticonvulsants such as barbiturates, hydantoins, succinamides, 
oxazolidinediones and acetylureas in that it has no
nitrogen or aromatic moiety. 
_Inactive_: 
 
Crushable:  includes maize starch, kaolin, silicon dioxide and
magnesium stearate. 
Enteric-Coated:  includes povidone, purified talc, magnesium stearate, calcium silicate, 
anhydrous citric acid, macrogol 6000, hypromellose,
polyvinyl acetate phthalate, diethyl 
phthalate, stearic acid, amaranth
aluminium lake, indigo carmine aluminium lake, titanium 
dioxide. 
Sugar-Free Liquid:  includes hydroxyethylcellulose, saccharin
sodium, sorbitol solution (70%) 
(non-crystallising), anhydrous citric acid, brilliant scarlet 4R, purified water, flavour imitation 
cherry 17.40.0740, sodium methyl hydroxybenzoate and
sodium propyl hydroxybenzoate. 
Syrup: includes sucrose, sorbitol, saccharin sodium, brilliant
scarlet 4R, purified water, flavour 
imitation cherry 17.40.0740, sodium methyl hydroxybenzoate and
sodium propyl 
hydroxybenzoate. 
PHARMACOLOGY 
CLASS:  Anticonvulsant, antipsychotic. 
CH
3
CH
2
CH
2
CHCOONa
CH
3
CH
2
CH
2
 
 
Epilim Oral PI 
CCDSv14 PIv8 2 Oct 12
 
Page 2  
 
SITE AND MODE OF ACTION:  The mode of action of Epilim has not been fully established.  Its 
anticonvulsant effect is attributed to the blockade of voltage dependent Na
+ 
chan
                                
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