TOPAMAX SPRINKLE CAPSULE 15MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TOPIRAMATE

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

TOPIRAMATE

Unit dalam pakej:

60Capsule Capsules

Dikeluarkan oleh:

JANSSEN ORTHO LLC

Risalah maklumat

TOPAMAX
® TABLET/SPRINKLE CAPSULE
Topiramate (25mg, 50mg, 100mg /15mg)
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 be

Ciri produk

1
PRODUCT NAME
TOPAMAX ®
DOSAGE FORMS AND STRENGTHS
Film -coated tablet.
Sprinkle capsule .
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 “TOPAMA X” on one side and “100” on the
other. Each tablet contains 100 mg of topiramate.
Sprinkle Capsules
15 mg capsule
Small, white to off -white spheres in a gelatin capsule consisting of a white body with a clear
or natural cap, printed in black ink with “TOP ” on the cap and “15 mg” on the body. Each
capsule contains 15 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 a s 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 be en 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