EPILIM 200 ENTERIC-COATED TABLET

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

SODIUM VALPROATE

Доступна з:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

ІПН (Міжнародна Ім'я):

SODIUM VALPROATE

Одиниць в упаковці:

100Tablet Tablets

Виробник:

SANOFI-AVENTIS, S.A

інформаційний буклет

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
EPILIM 200 ENTERIC COATED TABLET
Sodium Valproate 200mg
WARNING
Epilim,
Sodium
Valproate
can
seriously
harm
an
unborn
child
when taken during pregnancy. If
you are a female able to have a
baby
you
must
use
at
least
one
effective method of birth control
(contraception)
without
interruption
during
your
entire
treatment with Epilim. Your doctor
should discuss with you the most
appropriate
method
of
contraception for you.
Schedule
an
urgent
appointment
with your doctor if you want to
become pregnant or if you think
you are pregnant.
You must not stop taking Epilim
unless your doctor tells you to as
your condition may become worse.
WHAT IS IN THIS LEAFLET
1.
What Epilim is used for
2.
How Epilim works
3.
Before you use Epilim
4.
How to use Epilim
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Epilim
8.
Product Description
9.
Manufacturer
and
Product
Registration
Holder
10.
Date of revision
WHAT EPILIM IS USED FOR
Epilim is used to treat few types of
epilepsy
(fits)
in
adults
and
children.
Epilim may also be used to control
bipolar
disorder,
a
mental
condition
with
mania
symptoms
(an elevation of mood).
HOW EPILIM WORKS
Epilim Enteric-coated (EC) have a
protective coating that allows it to
reach the intestines (gut) without
being
dissolved
in
the
stomach
first.
This
helps
stop
it
from
causing a stomach upset.
Epilim contains a medicine called
sodium valproate. This belongs to
a group of medicines called anti-
convulsants
or
anti-epileptic
agents.
It
works
by
helping
to
calm the brain down.
BEFORE YOU USE EPILIM
-
_When you must not use it_
Bipolar disorder
•
For bipolar disorder, you must
not
use
Epilim
if
you
are
pregnant.
•
For bipolar disorder, if you are a
woman able to have a baby, you
must not take Epilim, unless you
use at least one effective method
of
birth
control
(contraception)
during your entire treatment with
Epilim. You must not stop taking
Epilim
or
interrupt
your
contraception,
until
you
have
discussed
this
with
your
doctor.
Y

Характеристики продукта

1
DRAFT PACKAGE INSERT
NAME OF THE MEDICINAL PRODUCT
EPILIM 200 ENTERIC COATED
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epilim 200 Enteric Coated Tablets contain 200mg of Sodium Valproate
PHARMACEUTICAL FORM
Enteric coated tablets
INDICATIONS
Treatment of generalized or partial epilepsy, particularly with the
following patterns of seizures:
- Absence
- Myoclonic
- Tonic-clonic
- Atonic
- Mixed
As well as, for partial epilepsy:
- Simple or complex seizures
- Secondary generalized seizures
- Specific syndromes (West, Lennox-Gastaut)
Treatment and prevention of mania associated with bipolar disorder.
DOSAGE AND METHOD OF ADMINISTRATION
Epilim 200 Enteric Coated Tablets are for oral administration.
Daily dosage requirements vary according to age and body weight.
Epilim tablets may be given twice daily. Tablets should be swallowed
whole and not crushed or
chewed.
In
patients
where
adequate
control
has
been
achieved
Epilim
Chrono
formulations
are
interchangeable
with
other
Epilim
conventional
or
prolonged
release
formulations
on
an
equivalent daily dosage basis.
_DOSAGE _
Usual requirements are as follows:
_TREATMENT OF EPILEPSY _
Adults
Dosage should start at 600mg daily increasing by 200mg at three-day
intervals until control is
achieved. This is generally within the dosage range 1000mg to 2000mg
per
day, ie 20-
30mg/kg/day body weight. Where adequate control is not achieved within
this range the dose
may be further increased to 2500mg per day.
Children over 20kg
Initial dosage should be 400mg/day (irrespective of weight) with
spaced increases until control is
achieved; this is usually within the range 20-30mg/kg body weight per
day. Where adequate
control is not achieved within this range the dose may be increased to
35mg/kg body weight per
day.
Children under 20kg
An alternative formulation of Epilim should be used in this group of
patients, due to the tablet size
and need for dose titration. Epilim Syrup is an alternative.
20mg/kg of body weight per day; in severe cases this may be increased
but only in patients i