Epilim Enteric 200 mg gastro-resistant coated tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Sodium valproate

から入手可能:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATCコード:

N03AG; N03AG01

INN（国際名）:

Sodium valproate

投薬量:

200 milligram(s)

医薬品形態:

Gastro-resistant tablet

処方タイプ:

Product subject to prescription which may be renewed (B)

治療領域:

Fatty acid derivatives; valproic acid

認証ステータス:

Marketed

承認日:

1983-08-30

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM® ENTERIC 200 MG AND 500 MG GASTRO-RESISTANT COATED TABLETS
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 BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please 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
possibl

製品の特徴

Health Products Regulatory Authority
11 March 2024
CRN00F60S
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 Enteric 200 mg gastro-resistant coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg of Sodium Valproate.
Excipients with known effect:
Sodium 27.68 mg (see section 4.4).
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant coated tablets.
Lilac, biconvex gastro-resistant coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Enteric 200mg Gastro-resistant coated tablets are for oral
administration.
Daily dosage requirements vary according to age and body weight.
Epilim tablets may be given twice daily. Tablets should be swallowed
whole and not crushed or chewed.
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