Epilim Syrup 200mg/5ml Oral Solution

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Sodium valproate

Saatavilla:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC-koodi:

N03AG; N03AG01

INN (Kansainvälinen yleisnimi):

Sodium valproate

Annos:

200 mg/5ml

Lääkemuoto:

Oral solution

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Fatty acid derivatives; valproic acid

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1983-11-01

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM® SYRUP 200 MG/5 ML ORAL SOLUTION
Sodium valproate
▼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.
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
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 effective method of birth
control (contraception) without
interruptions during your entire treatment with Epilim. Your doctor
will discuss this with you but you
must also follow the advice in section 2 of this leaflet.
Schedule an urgent appointment with your doctor if you want to become
pregnant or if you think you
are pregnant.
Do not stop taking Epilim unless your doctor tells you to as your
condition may become worse._ _
OTHER SOURCES OF INFORMATION
For the most up to date patient information leaflet and important
safety
information on this product for girls and women of childbearing
potential scan
the QR code included in this leaflet and on the carton label with a
smartphone.
The same information is also available on the following URL:
qr.epilimandme.ie
Patients should select the electronic patient information leaflet
which matches
the name of their medicine, the name of this medicine is stated in
full at the
beginning of this leaflet.
qr.epilimandme.ie
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
IN THIS LEAFLET:
1.
Wha

Valmisteyhteenveto

Health Products Regulatory Authority
11 March 2024
CRN00F60S
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 Syrup 200mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of syrup contains Sodium Valproate 200.0mg.
Excipients:
Each 5ml contains:
Sucrose 3.575g
Sorbitol 647.5mg
Sodium methyl parahydroxybenzoate 5mg
Sodium propyl parahydroxybenzoate 1mg
Ponceau 4R 2mg
Ethanol 2.8 micrograms
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Syrup.
Clear, cherry red syrup with characteristic fruity, cherry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy.
4.2 POSOLOGY 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.
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:
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, i.e. 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.
FEMALE CHILDREN AND WOMEN OF CHILDBEARING POTENTIAL
Epilim must be initiated and supervised by a specialist experienced in
the management of epilepsy. Valproate should not be
used in female children and women of childbearing potential unless
other treatments are ineffective or not tolerated (see
section 4.4 and 4.6).
Valproate i