LAMOGA-25mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
02-02-2021
Ciri produk Ciri produk (SPC)
02-02-2021

Bahan aktif:

LAMOTRIGINE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

LAMOTRIGINE

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

UNISON LABORATORIES CO.LTD

Risalah maklumat

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LAMOGA TABLET
Lamotrigine (25 mg, 50 mg and 100 mg) 1
WHAT IS IN THIS LEAFLET
1.
What LAMOGA is used for
2.
How LAMOGA works
3.
Before you use LAMOGA
4.
How to use LAMOGA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of LAMOGA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LAMOGA IS USED FOR
LAMOGA
can
be
used
in
two
different conditions: Epilepsy and
Bipolar
disorder
(maniac
depression).
ASK YOUR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT WHY
LAMOTRIGINE HAS BEEN PRESCRIBED
FOR
YOU.
Your
doctor
may
have
prescribed it for another reason.
HOW LAMOGA WORKS
_Epilepsy _
LAMOGA
is
used
to
treat
or
prevent various types of epilepsy
in adults and children.
LAMOGA may be used on its own
to treat adults and children over 12
years.
LAMOGA
can
also
be
used
in
combination
with
other
anti-
epileptic medicines in both adults
and
children
aged
2
years
and
over.
Sometimes
other
anti-
epileptic
medicines
may
be
stopped after LAMOGA has been
started.
_Bipolar Disorder _
LAMOGA
is
also
used
to
help
prevent depression in adults over
18
years
of
age
with
bipolar
disorder. LAMOGA should not be
used
to
treat
bipolar
disorder
in
children (under 18 years of age).
BEFORE YOU USE LAMOGA
_- When you must not use it _
Do not take or use LAMOGA if
you are hypersensitive (allergic) to
Lamotrigine or any
of the other
ingredients of LAMOGA Tablets.
LAMOGA
is not recommended for
treatment
of
epilepsy
in
children
under 2 years of age.
_- Before you start to use it _
Talk to your doctor or pharmacist
before taking LAMOGA:
_ _
•
If you have any kidney problems
•
If
you
have
ever
developed
a
rash after taking Lamotrigine or
other
medicines
for
bipolar
disorder or epilepsy
•
If
you
have
ever
developed
meningitis
(swelling
of
the
membranes
of
the
brain
and
spinal
cord)
after
taking
Lamotrigine
•
If
you
are
already
taking
medicine
that
contains
Lamotrigine
•
If you have intolerance to a type
o
                                
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Ciri produk

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LAMOGA-25
LAMOGA-50
LAMOGA-100
ANTIEPILEPTIC
Each film coated tablet contains:
LAMOTRIGINE 25 MG
LAMOTRIGINE 50 MG
LAMOTRIGINE 100 MG

PRODUCT DESCRIPTION:
_25 MG:_
Pale yellow, arc-square film coated tablet with plain flat face on one
side and slope edge, flat face with engraved 25 on
the other side
_50 MG:_
Pale yellow, arc-square film coated tablet with plain flat face on one
side and slope edge, flat face with engraved 50 on
the other side
_100 MG:_
Pale yellow, arc-square film coated tablet with plain flat face on one
side and slope edge flat face with engraved 100
on the other side

MECHANISM OF ACTION:
_PHARMACOLOGY _
It is suggested that Lamotrigine is a use- and voltage-dependent
blocker of voltage gated sodium channels. It inhibits
sustained repetitive firing of neurons and inhibits release of
glutamate (the neurotransmitter which plays a key role in
the generation of epileptic seizures). These effects are likely to
contribute to the anticonvulsant properties of
Lamotrigine.
In contrast, the mechanisms by which Lamotrigine exerts its
therapeutic action in bipolar disorder have not been
established, although interaction with voltage gated sodium channels
is likely to be important.
_PHARMACOKINETICS _
Absorption
Lamotrigine is rapidly and completely absorbed from the gut with no
significant first-pass metabolism. Peak plasma
concentrations
occur
approximately
2.5
hours
after
oral
administration
of
Lamotrigine.
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.
Biotransformation
UDP-glucuronyl transferases have been identified as the enzymes
responsible for metabolism of Lamotrigine.
Lamotrigine induces its own met
                                
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