Zonegran 100mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ZONISAMIDE

Boleh didapati daripada:

EISAI (MALAYSIA) SDN BHD (18039-D)

INN (Nama Antarabangsa):

ZONISAMIDE

Unit dalam pakej:

100tablet Tablets

Dikeluarkan oleh:

Bora Pharmaceuticals Co.,Ltd.

Risalah maklumat

_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ZONEGRAN TABLETS
®
Zonisamide 100mg
1
WHAT IS IN THIS LEAFLET
1.
What
_Zonegran_
_® _
is used for
2.
How
_Zonegran_
_® _
works
_3._
_ _
Before you use
_Zonegran_
_®_
_ _
_4._
_ _
How to use
_Zonegran_
_®_
_ _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Zonegran_
_®_
_ _
8.
Product Description
9.
Manufacturer and
Product Registration
Holder
10.
Date of revision
WHAT _ZONEGRAN_
_® _
IS USED FOR
Zonegran
®
contains
the
active
substance zonisamide, and is used as
an antiepileptic medicine.
Zonegran
®
is used to treat seizures that
affect one part of the brain (partial
seizure), which may or may not be
followed by a seizure affecting all of
the brain (secondary generalisation).
Zonegran
®
may be used:
•
On
its
own
to
treat
seizures
in
adults.
•
With other antiepileptic medicines
to treat seizures in adults.
HOW _ZONEGRAN_
_® _
WORKS
The brain and nerves are made of
cells that communicate with each
other via electrical signals. These
signals
are
usually
carefully
regulated by the nervous system.
However, in a person with epilepsy,
the
electrical
signals
sometimes
become
unusually
fast
and
repetitive. This can over-stimulate
the brain and cause a seizure.
Zonegran
®
works by stabilizing the
electrical activity in the brain. This can
help to reduce the risk of the brain
being over-stimulated and can help to
reduce the frequency of seizures in
some people.
BEFORE YOU USE _ZONEGRAN_
_®_
_ _
-
_When you must not use it _
Do not take Zonegran
®
if you:
•
are allergic to zonisamide or any
of the ingredients in Zonegran
•
are allergic to other sulphonamide
medicines.
Example
includes
sulphonamide
antibiotics,
thiazide
diuretics,
and
sulfonylurea medicines.
Zonegran
®
belongs
to
a
group
of
medicines
(sulphonamides)
which
can cause severe allergic reactions,
severe
skin
rashes,
and
blood
disorders, which very rarely can be
fatal.
Serious rashes occur in association
with Zonegran
®
therapy, including
cases of Stevens-Jo

Ciri produk

- ANTIEPILEPTIC DRUG -
ZONEGRAN

TABLETS 100 MG

1.
NAME OF THE MEDICINAL PRODUCT
Zonegran Tablets 100mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet Zonegran Tablet contains 100mg of zonisamide
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Zonegran Tablets 100mg is a white film-coated tablet.
It is round, with diameter of 8mm and thickness of 3.6mm.
Marking on the face :
E
and reverse side : blank
132
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zonegran is indicated as:
•
monotherapy in the treatment of partial seizures, with or without
secondary generalisation, in
adults with newly diagnosed epilepsy (see section 5.1);
•
adjunctive therapy in the treatment of partial seizures in adults with
epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology - Adults
_Dosage escalation and maintenance _
Zonegran may be taken as monotherapy or added to existing therapy in
adults. The dose should be
titrated on the basis of clinical effect. Recommended escalation and
maintenance doses are given in
Table 1. Some patients, especially those not taking CYP3A4-inducing
agents, may respond to lower
doses.
_Withdrawal _
When Zonegran treatment is to be discontinued, it should be withdrawn
gradually (see section 4.4). In
clinical studies of adult patients, dose reductions of 100 mg at
weekly intervals have been used with
concurrent adjustment of other antiepileptic medicine doses (where
necessary).
TABLE 1. ADULTS – RECOMMENDED DOSAGE ESCALATION AND MAINTENANCE
REGIMEN
TREATMENT REGIMEN
TITRATION PHASE
USUAL MAINTENANCE DOSE
MONOTHERAPY
- Newly diagnosed adult
patients
WEEK 1 + 2
WEEK 3 + 4
WEEK 5 + 6
300 mg per day
(once a day).
If a higher dose is required:
increase at two-weekly
intervals in increments of
100 mg up to a maximum
of 500 mg.
100 mg/day
(once a
day)
200 mg
/day
(once a
day)
300 mg /
day
(once a
day)
ADJUNCTIVE THERAPY
For adults, usually 100 to 200 mg of
zonisamide is to be administered orally
1 to 3 times a day initially. The dose is
gr