TOPAMAX TABLET 25MG

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

TOPIRAMATE

Dostupné z:

JOHNSON & JOHNSON SDN BHD

INN (Medzinárodný Name):

TOPIRAMATE

Počet v balení:

60Tablet Tablets

Výrobca:

CILAG AG

Príbalový leták

TOPAMAX
® TABLET
Topiramate (25mg, 50mg, 100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What TOPAMAX
®
is used for
2.
How TOPAMAX
®
works
3.
Before you use TOPAMAX
®
4.
How to use TOPAMAX
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of TOPAMAX
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT TOPAMAX
® IS USED FOR
TOPAMAX
®
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
TOPAMAX
®
for another reason. Ask your
doctor if you have any questions about
why this medicine has been prescribed for
you.
HOW TOPAMAX
® WORKS
Although the exact way TOPAMAX
®
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 TOPAMAX
®
-
_When you must not use it _
•
if you are allergic (hypersensitive) to
topiramate or any of the other
ingredients of TOPAMAX
®
(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 TOPAMAX
®
.
If you are not sure if the above applies
to you, talk to your doctor or pharmacist
before using TOPAMAX
®
.
_Pregnancy and breast-feeding _
Migraine prevention:
TOPAMAX
®
can harm an unborn baby.
You must not use TOPAMAX
®
if you
are pregnant. You must not use
TOPAMAX
®
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 contraceptio

Súhrn charakteristických

1
PRODUCT NAME
TOPAMAX
®
DOSAGE FORMS AND STRENGTHS
FILM-COATED TABLETS
The tablets are debossed, engraved or embossed.
25 MG TABLET
Round, white tablet imprinted with “TOP” on one side and “25”
on the other. Each tablet
contains 25 mg of topiramate.
50 MG TABLET
Round, light yellow tablet imprinted with “TOP” or “TOPAMAX”
on one side and “50” on
the other. Each tablet contains 50 mg of topiramate.
100 MG TABLET
Round, yellow tablet imprinted with “TOP” or “TOPAMAX” on one
side and “100” on the
other. Each tablet contains 100 mg of topiramate.
For excipients, see
_List of Excipients._
CLINICAL INFORMATION
INDICATIONS
EPILEPSY
TOPAMAX
is indicated as monotherapy in patients with newly diagnosed epilepsy
or for
conversion to monotherapy in patients with epilepsy.
TOPAMAX is indicated as adjunctive therapy for adults and children
aged 2 and above with
partial onset seizures or generalized tonic-clonic seizures.
TOPAMAX is also indicated in adults and children as adjunctive therapy
for the treatment of
seizures associated with Lennox-Gastaut syndrome.
MIGRAINE
TOPAMAX
is indicated in adults for the prophylaxis of migraine headache. The
usefulness of
TOPAMAX
in the acute treatment of migraine headache has not been studied.
DOSAGE AND ADMINISTRATION
It is not necessary to monitor topiramate plasma concentrations to
optimize therapy with
TOPAMAX. On rare occasions, the addition of TOPAMAX to phenytoin may
require an
adjustment of the dose of phenytoin to achieve optimal clinical
outcome. Addition or
withdrawal of phenytoin and carbamazepine to adjunctive therapy with
TOPAMAX may
require adjustment of the dose of TOPAMAX.
DOSAGE
It is recommended that therapy be initiated at a low dose followed by
titration to an effective
dose.
_EPILEPSY – ADJUNCTIVE THERAPY _
•
ADULTS
2
Therapy should begin at 25 to
50 mg nightly for one week. Use of lower initial doses has been
reported, but has not been studied systematically. Subsequently, at
weekly or bi-weekly
_ _
intervals, the dose should be