LAMITOR 50MG TABLET

Country: Malaysia

Language: English

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

Active ingredient:

LAMOTRIGINE

Available from:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (International Name):

LAMOTRIGINE

Units in package:

30 Tablet Tablets; 50 Tablet Tablets; 50Tablet Tablets; 10 Tablet Tablets; 100 Tablet Tablets

Manufactured by:

TORRENT PHARMACEUTICAL LIMITED

Patient Information leaflet

LAMITOR TABLETS
_ _
Lamotrigine (25 mg, 50 mg, 100 mg)
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Lamitor used for
2.
How Lamitor works
3.
Before you use Lamitor
4.
How to use Lamitor
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Lamitor
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT LAMITOR IS USED FOR
Lamotrigine
is
an
anti-epileptic
medication.
Lamotrigine
are
used
to
treat seizure and bipolar disorder.
HOW LAMITOR WORKS
Lamotrigine
is
known
as
an
anticonvulsant or antiepileptic drug. It
is
thought
to
work
by
restoring
the
balance of certain natural substances in
the brain.
Lamotrigine
tablets
treat
epilepsy
by
blocking the signals in the brain that
trigger epileptic seizures (fits).
BEFORE YOU USE LAMITOR
-
_When you must not use it _
Do not take Lamitor:
•
If
you
are
hypersensitive
to
Lamotrigine
or
any
of
the
other
ingredients of this medicine.
_Pregnancy and lactation_
_ _
Do not take Lamitor if you are pregnant
or plan to become pregnant or think you
might be pregnant.
Do not take Lamitor if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it _
Please tell your doctor if you have any
other
condition
or
illness,
as
your
doctor
may
need
to
take
this
into
consideration.
In
particular,
tell
your
doctor:
•
If
you
feel
suicidal
thoughts
or
harming yourself.
•
If
you
have
any
kidney
or
liver
problem.
•
If you have ever developed a rash
after taking Lamotrigine, A small
number
of
people
taking
Lamotrigine
get
an
allergic
reaction
or
potentially
life-
threatening skin reaction.
•
Consumers
should
be
warned
to
consult their doctors immediately if
rashes
or
flu-like
symptoms
associated
with
hypersensitivity
develop.
•
Dosage
recommendations
should
not be exceeded to minimise the
risk
of
developing
rash
which
require withdrawal of the therapy.
Sudden withdrawal of Lamotrigine
may stimulate back the seizures.
Talk
to
y

Summary of Product characteristics

PRODUCT NAME
:
ITEM / PACK
:
DESIGN STYLE
:
CODE
:
DIMENSIONS (MM)
:
ART WORK SIZE
:
DATE
:
Reviewed By
NO. OF COLORS: 1
COUNTRY : Malaysia
Front/Back
Lamitor
Insert
S/S
180 x 270
xxxxxxxx-5253
Black
06-04-2020
PANTONE SHADE NOS.:
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
LOCATION :
Chhatral
QUALITY
Approved By
DESCRIPTION
Lamitor 25 mg Tablets: Light yellow coloured, round, flat, uncoated
tablets
with bisecting line on one side (Thickness1.9 - 2.3mm, average weight
85.0mg and diameter 6.35mm).
Lamitor 50 mg Tablets: Light yellow coloured, round, flat, uncoated
tablets
with bisecting line on one side (Thickness 2.5 - 2.9mm, average weight
170.0mg and diameter 7.93mm).
Lamitor 100 mg Tablets: Light yellow coloured, round, flat, uncoated
tablets
with bisecting line on one side (Thickness 3.0 - 3.4mm, average weight
340.0mg and diameter 10.31mm).
Lamotrigine is an antiepileptic drug of phenyltriazine class. It’s
chemical
name is 6-(2,3-dichlorophenyl)-1,2,4-triazine-3, 5-diamine, its
molecular
formula is C
9
H
7
Cl
12
N
5
and molecular weight is 256.09. Lamotrigine is white
to pale cream coloured powder and has a Pka of 5.7. It is very
slightly
soluble in water (0.17 mg/ml at 25
o
C) and slightly soluble in 0.1 M HCl (4.1
mg/ml at 25
o
C).
COMPOSITION
LAMITOR 25 MG TABLETS: Each tablet contains 25 mg lamotrigine.
LAMITOR 50 MG TABLETS: Each tablet contains 50 mg lamotrigine.
LAMITOR 100 MG TABLETS: Each tablet contains 100 mg lamotrigine.
MODE OF ACTION:
Results
of
pharmacological
studies
suggest
that
LAMITOR
is
a
use-dependent blocker of voltage gated sodium channels. It produces a
use and voltage-dependent block of sustained repetitive firing in
cultured
neurones 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