Epilim Chrono 300 Controlled Release

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

VALPROATE SODIUM

Dostępny od:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

Kod ATC:

N03AG01

INN (International Nazwa):

VALPROATE SODIUM 300 mg

Forma farmaceutyczna:

PROLONGED-RELEASE TABLET

Skład:

VALPROATE SODIUM 300 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTIEPILEPTICS

Status autoryzacji:

Withdrawn

Data autoryzacji:

2006-01-18

Ulotka dla pacjenta

1
PACKAGING ADMINISTRATION : SANOFI AMBARÈS - FRANCE 
LIBELLÉ :
NOT EPILIM CHR CP DC RL GB
ITEM CODE
555731
CREATION DATE
03/06/2014
COUNTRY
GRANDE BRETAGNE
CODE LAETUS
1068
BASED ON
529153
BY
D. PAPON
FORMAT
170X210 DC
COLOR
2
ARTICLE
NOTICE DC
MODIFICATION DATE
12/02/2015
BRAND MARK LOGO
...........
FONTS
OCEAN SANS PRO SAN
PROFF N°
10
BY
I. SOURBE
COUBTRY REQUIREMENT 
CRGB - V1 – 05 /2012
FONT SIZE
8 PT
THIS ARTWORK PROOF INDICATES COLOUR POSITION ONLY.
PLEASE REFER TO PANTONE COLOUR FORMULA
USED COLOR PRINTABLE: 
NO PRINTABLE COLOR:
PANTONE REFLEX BLUE ET 
PANTONE BLACK-> TRIANGLE
PLAN
PACKAGE LEAFLET: 
INFORMATION FOR THE USER
EPILIM® CHRONO 200MG, 300MG
AND 500MG CONTROLLED RELEASE 
TABLETS
sodium valproate
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
This medicine is subject to additional monitoring. This
will allow quick identification of new safety information. You
can help by reporting any side effects you may get. See the
end of section 4 for how to report side effects
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE  BECAUSE  IT  CONTAINS  IMPORTANT  INFORMATION  FOR
YOU.
• Keep this leaflet. You may need to read it again
• If you have further questions, please ask your doctor or
pharmacist
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them even if their symptoms are
the same as yours
•  If you get any side effects, talk to your doctor or pharma-
cist. This includes any possible side effects not listed in this
leaflet. See section 4. 
WHAT IS IN THIS LEAFLET
1. What Epilim Chrono is and what it is used for
2. What you need to know before you take Epilim Chrono
3. How to take Epilim Chrono
4. Possible side effects
5. How to store Epilim Chrono
6. Co

Charakterystyka produktu

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
_▼_
_ _This medicinal product is subject to additional monitoring. This
will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse reactions. See section 4.8 for how to report adverse
reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Epilim Chrono 300 Controlled Release
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents
Each tablet contains 199.8mg Sodium Valproate and 87.0mg Valproic Acid
equivalent to
300mg sodium valproate.
3.
PHARMACEUTICAL FORM
Prolonged Release Tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy.
4.2
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 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.
Page 2 of 17
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.