LAMOTRIGINE ARW lamotrigine 50 mg dispersible tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

lamotrigine

Saadav alates:

Arrow Pharma Pty Ltd

INN (Rahvusvaheline Nimetus):

Lamotrigine

Volitamisolek:

Registered

Infovoldik

LAMITAN (lamotrigine) dispersible tablets – Consumer Medicine
Information
Page 1 of 4
LAMITAN
5 MG, 25 MG, 50 MG, 100 MG & 200 MG DISPERSIBLE TABLETS
_lamotrigine _
CONSUMER MEDICINE INFORMATION (CMI)
There are reports of severe, potentially life-threatening rashes
associated with lamotrigine treatment, particularly in
children. Lamitan should be discontinued at the first sign of rash
unless the rash is clearly not drug related.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LAMITAN. 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 benefits and
risks. Your doctor has weighed the
risks of you taking LAMITAN tablets
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT LAMITAN IS USED
FOR
Lamotrigine (the active ingredient in
LAMITAN tablets) belongs to a
group of medicines called “anti-
epileptic drugs”.
LAMITAN tablets are used to treat
epilepsy, including partial or
generalised seizures, in adults and
children. In general, it is initially
used [in addition to other medicines]
for treatment of this condition.
An epileptic seizure, fit or turn
results when abnormal electrical
impulses occur in nerve cells in the
brain. These abnormal electrical
impulses are believed to be due to
altered levels of some chemicals in
the brain. It is thought to work by
changing the levels of some of the
chemicals associated with seizures.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LAMITAN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LAMITAN IF YOU ARE
ALLERGIC TO LAMOTRIGINE OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Some of

Toote omadused

LAMITAN (lamotrigine) – Product Information
Page 1 of 21
PRODUCT INFORMATION
LAMITAN 5, 25, 50, 100, 200
_lamotrigine dispersible tablets 5/25/50/100/200 mg _
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. CAS:
84057-84-1.
DESCRIPTION
Lamotrigine is a substituted asymmetric triazine. The pKa of
lamotrigine at 25
⁰
C is 5.7. It is a
white to pale cream coloured powder. It is slightly soluble in ethanol
and chloroform and very
slightly soluble in water.
The active ingredient in LAMITAN tablets is lamotrigine.
The 25, 50,100 & 200 mg tablets also contain the inactive ingredients
crospovidone, povidone,
mannitol, microcrystalline cellulose, colloidal anhydrous silica,
aspartame, croscarmellose
sodium, magnesium stearate and trusil blackcurrant S4468 (PI).
The 5 mg tablets also contain the inactive ingredients povidone,
mannitol, microcrystalline
cellulose, colloidal anhydrous silica, saccharin sodium, purified
talc, croscarmellose sodium,
magnesium stearate and trusil blackcurrant S4468 (PI).
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 neurons in epileptic foci, thereby limiting the
spread of seizures.
In tests designed to evaluate the CNS effects of drugs, the results
obtained using doses of
lamotrigine 240 mg administer