EPILIM SYRUP 200MG5ML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SODIUM VALPROATE

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SODIUM VALPROATE

Unit dalam pakej:

300ml1Units mL

Dikeluarkan oleh:

Unither Liquid Manufacturing

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
1
EPILIM
® SYRUP
Sodium Valproate (200mg/5ml)
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 for the treatment of
generalised
(affects
the
entire
brain)
or
partial
(only
affects
a
small
part
of
the
rain)
epilepsy
(fits) with the following pattern of
seizures:
-
absence (a short period of
“blanking out")
-
myoclonic (brief, shock-like
jerks of muscles)
-
tonic-clonic
(muscles
stiffen,
and jerking movements)
-
atonic
(muscles
suddenly
lose strength)
-
mixed
-
simple (awareness is retained)
or
complex
(impairment
of
awareness) seizures
-
secondary
generalised
seizures (spread to both sides of
the brain after the initial event)
-
specific
syndromes
(Wes,
Lennox- Gastaut)
Epilim
may
also
be
used
to
control bipolar disorder, a mental
condition
with
mania
symptoms
(an elevation of mood).
HOW EPILIM WORKS
Epilim contains a medicine called
sodium valproate. This belongs to
a group of medicines called anti-
convulsants
or
anti-epileptic
agents.
It
works
by
controlling
brain
chemicals
which
send
signals to nerves so that seizures
do not happen.
BEFORE YOU USE EPILIM
_ When you must not use it_
Bipolar disorder
•
For bipolar d

Ciri produk

1
NAME OF THE MEDICINAL PRODUCT
EPILIM SYRUP/SODIUM VALPROATE 200MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of syrup contains Sodium Valproate 200mg.
PHARMACEUTICAL FORM
Syrup
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 Syrup is for oral administration.
Daily dosage requirements vary according to age and body weight.
Epilim Syrup may be given twice daily. If it is necessary to dilute
Epilim Syrup, the recommended
diluent is Syrup BP, but syrup containing SO
2
as a preservative
should not
be used. The diluted
product will have a 14-day shelf life.
In
patients
where
adequate
control
has
been
achieved
Epilim
Chrono
formulations
are
interchangeable with other 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
20mg/kg of body weight per day; in severe cases this may be increased
but only in patients in
whom plasma valproic acid levels can be monitored. Above 40mg/kg/day,
clinical chemistry and
haematologi