EPILIM CHRONO 500MG (OBLONG FILM C* )

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

SODIUM VALPROATE; VALPROIC ACID

Inapatikana kutoka:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Jina la Kimataifa):

SODIUM VALPROATE; VALPROIC ACID

Vitengo katika mfuko:

30Tablet Tablets

Viwandani na:

SANOFI WINTHROP INDUSTRIE

Taarifa za kipeperushi

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1
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_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
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EPILIM CHRONO 500MG
Sodium Valproate (500mg)
_ _
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 Chrono (controlled release
tablet) is slowly released from the
tablets over a period of time.
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 Chrono if you are pregnant.
-For bipolar disorder, if you are a
woman able to have a baby, you must
not take Epilim Chrono, unless you use
effective method of birth control
(contraception) during your entire
treatment with Epilim Chrono. Do not
stop taking Epilim Chrono or your
contraception, until you have discussed
this with your doctor. Your doctor will
advise you further (see below under
“Pregnancy, breast-feeding and fertility
– Important advice for women”).
_Epilepsy _
-For epilepsy, you must not use Epilim
Chrono if you are pregnant, unless
nothing else works for you.
-For epilepsy, if you are a woman able
to have a baby, you must not take
Epilim Chrono unless you use effective
method of birth control (contraception)
during your entire treatment with
Epilim Chrono. Do not stop taking
Epilim Chrono or your contraception,
until you have discussed this with your
doctor. Your doctor will advise you
further (see below under “Pregnancy,
breast-feeding and fertility – Important

Tabia za bidhaa

1
NAME OF THE MEDICINAL PRODUCT
Epilim Chrono 500 Controlled Release
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents
Each tablet contains 333mg Sodium Valproate and 145mg Valproic Acid
equivalent to 500mg
sodium valproate.
Excipients with known effect:
Sodium 46.08 mg (see Special Warnings and Precautions for Use).
PHARMACEUTICAL FORM
Prolonged Release Tablet.
PRODUCT DESCRIPTION
Oblong, practically white, scored film-coated tablets
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of generalized or partial epilepsy, particularly with the
following patterns of seizures:
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Absence
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Myoclonic
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Tonic-clonic
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Atonic
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Mixed
As well as, for partial epilepsy:
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Simple or complex seizures
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Secondary generalized seizures
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Specific syndromes (West, Lennox-Gastaut)
Treatment and prevention of mania associated with bipolar disorder.
POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Chrono Controlled Release Tablets are for oral administration.
Epilim Chrono is a prolonged release formulation of Epilim which
reduces peak concentration and ensures
more even plasma concentrations throughout the day.
Epilim Chrono 500 may be given once or twice daily. The tablets should
be swallowed whole and not
crushed or chewed.
Daily dosage requirements vary according to age and body weight.
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:
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 500mg/day (irrespective of weight) with
spaced increases until control is achieved;
this is usually within the range 20-30mg/kg body weight