TORATE 100MG TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TOPIRAMATE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

TOPIRAMATE

Unit dalam pakej:

60tablet Tablets; 100 Tablets; 3 X 10s Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit III),

Risalah maklumat

TORATE
TABLET
Topiramate (50mg, 100mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What TORATE
is used for
2.
How TORATE
works
3.
Before you use TORATE
4.
How to use TORATE
5.
While you are using it
6.
Side effects
7.
Storage and disposal of TORATE
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT TORATE IS USED FOR
TORATE
belongs to a group of medicines
called ‘antiepileptic medicines’. It is used:
•
alone to treat seizures in adults
•
with other medicines to treat seizures in
adults and children aged 2 years and
above
•
to prevent migraine headaches in adults
Your doctor may have prescribed
TORATE
for another reason. Ask your
doctor if you have any questions about
why this medicine has been prescribed for
you.
HOW TORATE
WORKS
Although the exact way TORATE works is
unknown, it's believed to help ‘calm’
overexcitable nerve cells in the brain so
they don't send out the signals that can
cause migraines or seizures.
BEFORE YOU USE TORATE
-
_When you must not use it _
•
if you are allergic (hypersensitive) to
topiramate or any of the other
ingredients of TORATE
(listed in
section ‘Product description’)
•
for migraine prevention: if you are
pregnant or if you are a woman of
childbearing potential unless you are
using effective contraception (see
section ‘Pregnancy and breast-
feeding’ for further information). You
should talk to your doctor about the
best kind of contraception to use
while you are taking TORATE.
If you are not sure if the above applies
to you, talk to your doctor or pharmacist
before using TORATE.
_Pregnancy and breast-feeding _
Migraine prevention:
TORATE
can harm an unborn baby.
You must not use TORATE
if you are
pregnant. You must not use TORATE
for migraine prevention if you are a
woman of childbearing potential unless
you are using effective contraception.
Talk to your doctor about the best kind
of contraception and whether TORATE
is suitable for you. Before the start of
treatment w

Ciri produk

TORATE 50 MG & 100 MG TABLETS
TOPIRAMATE TABLETS 50 MG & 100 MG
DESCRIPTION
TORATE 50MG TABLETS
Light yellow colored, circular, biconvex film-coated tablets debossed
with ‘E’ on one side and
‘33’ on the other side.
Each film-coated tablet contains topiramate 50mg.
TORATE 100MG TABLETS
Dark yellow colored, circular, biconvex beveled edged film-coated
tablets debossed with 'E' on one
side and '23' on the other side.
Each film tablet contains Topiramate 100 mg.
PHARMACODYNAMICS
Topiramate is classified as a sulfamate-substituted monosaccharide.
The precise mechanisms by
which topiramate exerts its antiseizure and migraine prophylaxis
effects are unknown.
Electrophysiological and biochemical evidence suggests that
topiramate, at pharmacologically
relevant concentrations, blocks voltage-dependent sodium channels,
augments the activity of the
neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A
receptor, antagonizes the
AMPA/kainate subtype of the glutamate receptor, and inhibits the
carbonic anhydrase enzyme,
particularly isozymes II and IV.
PHARMACOKINETICS
The pharmacokinetic profile of topiramate compared to other
antiepileptic drugs shows along plasma
half-life, linear pharmacokinetics, predominantly renal clearance, and
absence of significant protein
binding and lack of clinically relevant active metabolites.
Topiramate is not a potent inducer of drug metabolizing enzymes, can
be administered without regard
to meals, and routine monitoring of plasma topiramate concentrations
is not necessary. In clinical
studies, there was no consistent relationship between plasma
concentrations and efficacy or adverse
events.
INDICATION
1.
TORATE is indicated as monotherapy in patients with newly diagnosed
epilepsy or for
conversion to monotherapy in patients with epilepsy.
2.
TORATE is indicated as adjunctive therapy for adults and children 2
years and above with
partial onset seizures or generalized tonic-clonic seizures.
3.
TORATE is also indicated in adults and children as adjunctive therapy
for the tr