Epilim Chronosphere 250mg prolonged-release granules

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:

250 milligram(s)

Фармацевтична форма:

Prolonged-release granules

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Fatty acid derivatives; valproic acid

Статус Авторизація:

Marketed

Дата Авторизація:

2007-03-02

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM® CHRONOSPHERE® 100 MG PROLONGED RELEASE GRANULES
EPILIM® CHRONOSPHERE® 250 MG PROLONGED RELEASE GRANULES
EPILIM® CHRONOSPHERE® 500 MG PROLONGED RELEASE GRANULES
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 ef

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 Chronosphere 250mg prolonged-release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of prolonged-release granules contains:
Sodium valproate 166.76mg
Valproic acid 72.61mg
Equivalent to 250mg sodium valproate
Excipients with known effect:
Sodium 23.07 mg (see section 4.4).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release granules.
Sachets containing small, off-white to slightly yellow, waxy
microgranules.
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 Chronosphere for acute mania.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Chronosphere is a pharmaceutical form particularly suitable for
children (when they are able to swallow soft food) and
adults with swallowing difficulties.
Epilim Chronosphere is a controlled release formulation of Epilim,
which reduces peak concentration and ensures more regular
plasma concentration throughout the day.
Epilim Chronosphere may be given once or twice daily.
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 children and women of
childbearing potential unless other treatments are ineffective
or not tolerated (see section 4.4 and 4.6).
Valproate is prescribed and dispensed according to the Valproat