Epilim Chrono 200mg Prolonged Release Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Sodium valproate; Valproic acid

Доступна з:

Sanofi-Aventis Ireland Limited T/A SANOFI

Код атс:

N03AG; N03AG01

ІПН (Міжнародна Ім'я):

Sodium valproate; Valproic acid

Дозування:

200 milligram(s)

Фармацевтична форма:

Prolonged-release tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Fatty acid derivatives; valproic acid

Статус Авторизація:

Marketed

Дата Авторизація:

1992-08-24

інформаційний буклет

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.

Характеристики продукта

Health Products Regulatory Authority
11 March 2024
CRN00F60S
Page 1 of 18
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 200mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Epilim Chrono 200mg Prolonged Release Tablet contains 133.2mg
Sodium Valproate and 58.0mg Valproic Acid equivalent
to 200mg sodium valproate.
Excipients with known effect:
Sodium 18.43 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.
CHILDREN
Among the oral pharmaceutical forms, the following formulations are
more appropriate for administration to children less than
11 years (syrup, oral solution, granules).
_ _
FEMALE CHILDREN AND WOME