Epilim Chrono 500mg Prolonged Release Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Sodium valproate; Valproic acid

Boleh didapati daripada:

Sanofi-Aventis Ireland Limited T/A SANOFI

Kod ATC:

N03AG; N03AG01

INN (Nama Antarabangsa):

Sodium valproate; Valproic acid

Dos:

500 milligram(s)

Borang farmaseutikal:

Prolonged-release tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Fatty acid derivatives; valproic acid

Status kebenaran:

Marketed

Tarikh kebenaran:

1992-08-24

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM® CHRONO 200 MG, 300 MG AND 500 MG PROLONGED RELEASE TABLETS
Sodium valproate and Valproic acid
▼
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.

Ciri produk

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 Chrono 500mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Epilim Chrono 500mg Prolonged Release Tablet contains 333mg
Sodium Valproate and 145mg Valproic Acid equivalent
to 500mg sodium valproate.
Excipients with known effect:
Sodium 46.08 mg (see section 4.4).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
Violet, oblong, film-coated prolonged release tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy.
Treatment of manic episode in bipolar disorder when lithium is
contraindicated or not tolerated.
The continuation of treatment after manic episode could be considered
in patients who have responded to Epilim Chrono for
acute mania.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Chrono Prolonged 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 Epilim
conventional or prolonged release formulations on an equivalent daily
dosage basis.
FEMALE CHILDREN AND WOMEN OF CHILDBEARING POTENTIAL
Epilim must be initiated and supervised by a specialist experienced in
the management of epilepsy or bipolar disorder.
Valproate should not be used in female