Epilim Liquid, 200mg/5ml, liquid

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

VALPROATE SODIUM

Saadav alates:

Sanofi Malta Limited

ATC kood:

N03AG01

INN (Rahvusvaheline Nimetus):

VALPROATE SODIUM

Ravimvorm:

ORAL SOLUTION

Koostis:

VALPROATE SODIUM 200 mg/5ml

Retsepti tüüp:

POM

Terapeutiline ala:

ANTIEPILEPTICS

Volitamisolek:

Authorised

Loa andmise kuupäev:

2008-07-01

Infovoldik

1
301968 - 968
PACKAGE LEAFLET:
INFORMATION FOR THE USER
EPILIM 200MG/5ML LIQUID
sodium valproate

IS THIS LEAFL ET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
▼
 This medicine is subject to additional 
monitoring. This will allow quick identifi cation of 
new safety information. You can help by reporting 
any side eff ects you may get. See the end of section 
4 for how to report side eff ects.
WARNING
Valproate can cause birth defects and problems 
with early development of the child if it is 
taken during pregnancy. If you are a female of 
childbearing age you should use an eff ective 
method of contraception throughout your 
treatment.  
Your doctor will discuss this with you but you 
should also follow the advice in section 2 of this 
leafl et. Tell your doctor at once if you become 
pregnant or think you might be pregnant.
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
• Keep this leafl et. 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 eff ects, talk to your doctor or 
pharmacist. This includes any possible side eff ects 
not listed in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET 
1. What Epilim Liquid is and what it is used for
2. What you need to know before you take Epilim 
Liquid 
3. How to take Epilim Liquid
4. Possible side eff ects
5. How to store Epilim Liquid
6. Contents of the pack and other information 
1. WHAT EPILIM LIQUID IS AND WHAT IT           
IS USED FOR
WHAT EPILIM LIQUID IS
The name of your medicine is Epilim 200mg/5ml 
Liquid (called Epilim Liquid in this leafl et).
WHAT EPILIM LIQUID CONTAINS
Epilim Liquid contains a medicine called sodium 
valproate. This belongs to a group of medicines 
call

Toote omadused

Page 1 of 16
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 200mg/5ml Liquid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of liquid contains Sodium Valproate 200.0mg.
3.
PHARMACEUTICAL FORM
Liquid
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Liquid is for oral administration.
Daily dosage requirements vary according to age and body weight.
Epilim Liquid may be given twice daily. Epilim Liquid should not be
diluted.
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 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.
Page 2 of 16
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 haematological parameters should be monitored.
Use in the elderly
Although the pharmacokinetics of Epilim are modified in the