APO-Lamotrigine

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Lamotrigine; Calcium carbonate

Fáanlegur frá:

Apotex Pty Ltd

Tegund:

Medicine Registered

Upplýsingar fylgiseðill

APO-LAMOTRIGINE

_contains the active ingredient Lamotrigine_
CONSUMER MEDICINE INFORMATION

_FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055_

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about lamotrigine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Lamotrigine. It contains the active
ingredient lamotrigine.
Lamotrigine belongs to a group of
medicines called "anti-epileptic
drugs".
It is used to treat epilepsy in adults
and children aged 2 years and over.
Usually lamotrigine is used in
addition to other medicines for the
treatment of epilepsy. Lamotrigine is
used in partial seizures (seizures that
affect only one part of the brain) or
generalised seizures (seizures that
affect the whole brain), including
Lennox-Gastaut Syndrome (a severe
form of epilepsy characterised by
several seizure types).
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.

Vara einkenni

Product Information 
– Australia 
APO-Lamotrigine Tablets 
Page 1 
APO-LAMOTRIGINE TABLETS 

Severe, potentially life-threatening rashes have been reported in association with the use of lamotrigine, 
particularly in children. Accordingly, lamotrigine should be discontinued at the first sign of rash unless the 
rash is clearly not drug related (see DOSAGE AND ADMINISTRATION). 

NAME OF THE MEDICINE 
Lamotrigine. 

Chemical Name:  
3,5-diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine 

Molecular Weight:  
256.1 

CAS Number:  
84057-84-1 

DESCRIPTION 
APO-Lamotrigine tablets contain the active ingredient, lamotrigine. 

Lamotrigine is a substituted asymmetric triazine. It is a white to pale cream coloured powder. It is slightly 
soluble  in  ethanol  and  chloroform,  and  very  slightly  soluble  in  water.  The  pKa  of  lamotrigine  at  25°C  is 
5.7. 

PHARMACOLOGY 
The  precise  mechanism  of  the  anticonvulsant  action  of  lamotrigine  is  not  certain.  The  results  of 
neurochemical and electrophysiological studies with various _in vitro_ and _in vivo_ preparations indicate that 
lamotrigine can inhibit voltage gated sodium channels and reduce the release of glutamate, an excitatory 
amino  acid  implicated  in  the  pathophysiology  of  epilepsy.  It  is  possible  that  these  effects  underlie 
inhibition of the sustained repetitive firing of action potentials characteristic of neurones in epileptic foci, 
thereby limiting the spread of seizures.  

In  tests  designed  to  evaluate  the  central  nervous  system  effects  of  drugs,  the  results  obtained  using 
doses of 240 mg lamotrigine administered to healthy adult volunteers did not differ from placebo, whereas 
both 1000 mg