LAMOTRIGINE NORMON 50 mg CHEWABLE DISPERSIBLE TABLETS

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

LAMOTRIGINE

Available from:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Name):

LAMOTRIGINE

Units in package:

30tablet Tablets; 56tablet Tablets

Manufactured by:

LABORATORIOS NORMON, S.A.

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)
LAMOTRIGINE
NORMON
CHEWABLE
DISPERSIBLE TABLETS
Lamotrigine 50 mg/100 mg
1
WHAT IS IN THIS LEAFLET
1.
What
Lamotrigine
Normon
Tablets are used for
2.
How
Lamotrigine
Normon
Tablets work
3.
What you need to know before
you use Lamotrigine Normon
Tablets
4.
How
to
take
Lamotrigine
Normon Tablets
5.
While
you
are
using
Lamotrigine Normon Tablets
6.
Side Effects
7.
Storage
and
disposal
of
Lamotrigine Normon Tablets
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
LAMOTRIGINE
NORMON
TABLETS ARE USED FOR
Lamotrigine
is
derived
from
a
group
of
medicines
called
antiepileptics. It is used for the
treatment
of
two
types
of
the
diseases:
epilepsy
and
bipolar
disorder.
_Epilepsy: _
Lamotrigine Normon blocks the
signals to the brain that may cause
epileptic seizures (fit).
• In adults and children aged 13
years and over, Lamotrigine can
be
taken
by
itself
or
in
combination with other medicines
to
treat
epilepsy,
and
seizures
caused
by
a
disease
called
Lennox-Gastaut syndrome.
• For children aged 2 to 12 years,
Lamotrigine can be taken by itself
or
in
combination
with
other
medications
to
treat
the
same
diseases. It can also be used alone
for
the
treatment
of
a
type
of
epilepsy
called
‘typical
absence
seizures’.
_ _
_Bipolar disorder: _
People
with
bipolar
disorder
(formerly
known
as
manic
depressive
disorder)
experience
extreme
mood
swings,
with
periods
of
mania
(excitation
or
euphoria) alternating with periods
of
depression
(deep
sorrow
or
desperation).
In
adults
aged
18
years
and
above,
Lamotrigine
Normon can be used alone or in
combination with other drugs to
prevent the depression in bipolar
disorder.
HOW
LAMOTRIGINE
NORMON
TABLETS WORK
Lamotrigine Normon can be used
alone or in combination with other
drugs to prevent the depression in
bipolar disorder. It is not known
how
Lamotrigine
works
in
the
brain to provide the above effects.
WHAT YOU NEED TO KNOW BEFORE
YOU
USE
LAMOTRIGINE
NORMON
TABLETS
_When you must not take

Summary of Product characteristics

LAMOTRIGINE NORMON CHEWABLE/DISPERSIBLE TABLETS
PRODUCT DESCRIPTION
LAMOTRIGINE NORMON 50 MG CHEWABLE/DISPERSIBLE TABLETS ARE white or
almost white,
biconvex and round Chewable/Dispersible tablets. The weight of the 50
mg tablet is 130 mg ±
7.5% and the diameter is 7.65 mm ± 25%.
LAMOTRIGINE NORMON 100 MG CHEWABLE/DISPERSIBLE TABLETS are white or
almost white,
biconvex and round Chewable/Dispersible tablets. The weight of the 100
mg tablet is 260 mg and
the diameter is 9.65 mm ± 25%.
COMPOSITION
Each tablet of Lamotrigine NORMON 50 mg Chewable/Dispersible tablets
contains Lamotrigine
50 mg and each tablet of Lamotrigine NORMON 100 mg
Chewable/Dispersible tablets contains
Lamotrigine 100 mg.
PHARMACOLOGY
MECHANISM OF ACTION
The results of pharmacological studies suggest that lamotrigine is a
use and voltage dependent
blocker of voltage-gated Sodium channels. It produces a use~ and
voltage-dependent block of
sustained repetitive firing in cultured neurons and inhibits
pathological release of glutamate (the
amino acid which plays a key role in the generation of epileptic
seizures), as well as inhibiting
glutamate-evoked bursts of action potentials.
PHARMACOKINETICS
Absorption
Lamotrigine is rapidly and completely absorbed from the gut with no
significant first pass
metabolism. Peak plasma concentration occurs approximately 2-3 hours
after oral administration.
High interindividual variability in peak plasma concentration at
steady state prevails. Time to
maximum concentration is slightly delayed after food but the extent of
absorption is unaffected.
There is considerable inter-individual variation in steady state
maximum concentrations but within
an individual, concentrations rarely vary.
Distribution
Binding to plasma proteins is about 55%; it is very unlikely that
displacement from plasma proteins
would result in toxicity. The volume of distribution is 0.92 to 1.22
L/kg.
Metabolism
UDP-glucuronyl transferases have been identified as the enzymes
responsible for metabolism of
lamotrigine. Lamotrigine induces its o