EPIMATE 50 TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TOPIRAMATE

Boleh didapati daripada:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TOPIRAMATE

Unit dalam pakej:

30 Tablet Tablets; 100Tablet Tablets

Dikeluarkan oleh:

TORRENT PHARMACEUTICALS LTD.

Risalah maklumat

EPIMATE TABLET
_ _
Topiramate (50 mg, 100 mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Epimate used for
2.
How Epimate works
3.
Before you use Epimate
4.
How to use Epimate
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Epimate
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT EPIMATE IS USED FOR
Epimate
tablet
is
indicated
as
adjunctive
therapy
in
adults
and
children age between 2-16 years seizure
with partial onset seizures, or primary
generalized tonic-clonic seizures.
Epimate
tablet
is
also
indicated
as
adjunctive
therapy
in
adults
and
children for the treatment of seizures
associated
with
Lennox-Gastaut
syndrome (a type of epilepsy).
HOW EPIMATE WORKS
Topiramate
belongs
to
a
group
of
medicines
called
“antiepileptic
medicines.”
An epileptic seizure occurs as the result
of
abnormal
electrical
signals
in
the
brain.
Topiramate
prevents
fits
by
stabilising the electrical signals in the
brain.
BEFORE YOU USE EPIMATE
-
_When you must not use it _
Do not take Epimate if:
•
You are allergic (hypersensitive) to
topiramate
or
any
of
the
other
ingredients.
_Pregnancy and lactation _
_ _
_ _
Do
not
take
Epimate
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Epimate if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it _
You must tell your doctor or pharmacist
if you:
•
Have kidney problems, especially
kidney stones, or are getting kidney
dialysis.
•
Have
personality
disorder
or
mental illness.
•
Have liver problems.
•
Have
eye
problems,
especially
glaucoma.
•
Have
decreased
sweating
and
an
elevation in body temperature.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop.
Tell your doctor or pharmacist if you
are taking:
•
Other medicines for epi

Ciri produk

PRODUCT NAME
:
ITEM / PACK
:
DESIGN STYLE
:
CODE
:
DIMENSIONS (MM)
:
ART WORK SIZE
:
DATE
:
Reviewed By
NO. OF COLORS: 1
COUNTRY : Malaysia_Brunei
Front / Back
Epimate
Insert
S/S
150 x 540
xxxxxxxxxx-5253
Black
28-08-2020
PANTONE SHADE NOS.:
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
LOCATION :
Indrad
QUALITY
Approved By
COMPOSITION
Each tablet contains:
Topiramate 50/100 mg
DESCRIPTION
Topiramate is a sulfamate-substituted monosaccharide that is intended
for use as an antiepileptic drug.
Topiramate is a white crystalline powder with a bitter taste.
Topiramate is most soluble in alkaline solutions containing sodium
hydroxide or sodium phosphate and
having a pH of 9 to 10. It is freely soluble in acetone, chloroform,
dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL.
Its saturated solution has a
pH
of
6.3.
Topiramate
has
the
molecular
formula
C
12
H
21
NO
8
S
and
a
molecular
weight
of
339.37.
Topiramate
is
designated
chemically
as
2,3:4,5-Di-O-isopropylidene-
β
-D-fructopyranose sulfamate and has the following structural formula:
CLINICAL PHARMACOLOGY
Mechanism of action
The precise mechanism by which topiramate exerts its antiseizure
effect is unknown; however, electrophysiological and biochemical
studies of the effects of
topiramate on cultured neurons have revealed three properties that may
contribute to topiramate’s antiepileptic efficacy. First, action
potentials elicited repetitively by
a sustained depolarization of the neurons are blocked by topiramate in
a time-dependent manner, suggestive of a state-dependent sodium
channel blocking action.
Second, topiramate increases the frequency at which
γ
-aminobutyrate (GABA) activates GABA
A
receptors, and enhances the ability of GABA to induce a flux of
chloride ions into neurons, suggesting that topiramate potentiates the
activity of this inhibitory neurotransmitter. This effect was not
blocked by flumazenil, a
benzodiazepine antagonist, nor did topiramate increase the duration of
the channel open time, differenti