Kepcet

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

Levetiracetam

Verfügbar ab:

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

Klasse:

Medicine Registered

Gebrauchsinformation

KEPCET
®
_ _levetiracetam tablets 
CONSUMER 
MEDICINE 
INFORMATION       

WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about Kepcet. 

It does not contain all 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 you taking Kepcet 
against the benefits they expect it 
will have for you. 

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 KEPCET IS USED 
FOR 

Kepcet is used to control epilepsy.   

Epilepsy is a condition where you 
have repeated seizures (fits).  
There are many different types of 
seizures, ranging from mild to 
severe. 

Kepcet belongs to a group of 
medicines called antiepileptics.  
These medicines are thought to 
work by controlling brain chemicals 
which send signals to nerves so 
that seizures do not happen. 

Kepcet may be used alone, or in 
combination with other medicines, 
to treat your condition. 

Your doctor may prescribe Kepcet 
in addition to your current therapy.  

Ask your doctor if you have any 
questions about why Kepcet has 
been prescribed for you. 

There is no evidence that Kepcet is 
addictive. 

This medicine is available only with 
a doctor’s prescription. 
The safety and effectiveness of 
Kepcet has not been established in 
patients less than 4 years of age. 

BEFORE YOU TAKE KEPCET

_WHEN YOU MUST NOT TAKE IT _

DO NOT TAKE KEPCET IF YOU HAVE 
AN ALLERGY TO: 

•  any of the ingredients listed at 
the end of this leaflet 

Symptoms of an allergic reaction to 
Kepcet may include: 

•  shortness of breath, wheezing 
or difficulty breathing 
•  swelling of the face, lips, tongue 
or other parts of the body 
•  rash, itching or hives on the skin 

If you are unsure

Fachinformation

27
th
 March 2012 (G2012-087) 

PRODUCT INFORMATION 
KEPCET 
(LEVETIRACETAM)  
250 mg, 500 mg, 750 mg, 1000 mg film-coated tablets 

NAME OF THE MEDICINE 
Kepcet
®
 film-coated tablets contain the active substance levetiracetam; a
pure enantiomer, with 
chemical name (S)-
α-ethyl-2-oxo-1-pyrrolidineacetamide, formula C
8
H
14
N
2
O
2
, _CAS-102767-28-2_ 
and structure indicated below: 

DESCRIPTION 
Levetiracetam is a white to off-white powder with a faint odour and a
bitter taste. It is very soluble in 
water (104 g/100mL).  It is freely soluble in chloroform (65.3
g/100mL) and in methanol  
(53.6 g/100mL), soluble in ethanol (16.5 g/100mL), sparingly soluble
in acetonitrile (5.7 g/100mL) 
and practically insoluble in n-hexane. 

PHARMACOLOGY 

MECHANISM OF ACTION 
The precise mechanism of action by which levetiracetam induces
seizure protection still remains to 
be fully elucidated, but appears to be unrelated to the mechanisms
of current anti-epileptic drugs. 
_In vitro _
and _in vivo _experiments suggest that levetiracetam does not
alter basic cell characteristics 
and normal neurotransmission.  

_In vitro_
 studies show that levetiracetam affects intraneuronal Ca
2+
 levels by partial inhibition of N-
type Ca
2+
 currents and by reducing the release of Ca
2+
 from intraneuronal stores.  In addition, it 
partially reverses the reductions in GABA- and glycine-gated
currents induced by zinc and β-
carbolines.  Furthermore, levetiracetam has been shown in _in
vitro_ studies to bind to a specific site 
in rodent brain tissue.  This binding site is the synaptic vesicle
protein 2A, believed to be involved in 
vesicle fusion and neurotransmitter exocytosis.  Levetiracetam and
related analogues show a rank 
order of affinity for binding to the synaptic vesicle protein 2A which
correlates with the potency of 
their anti-seizure protection in the mouse audiogenic model
of epilepsy. This finding suggests that 
the int