Epilim Chrono 200mg Prolonged Release Tablets

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

VALPROATE SODIUM

Saatavilla:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC-koodi:

N03AG01

INN (Kansainvälinen yleisnimi):

VALPROATE SODIUM 200 mg

Lääkemuoto:

PROLONGED-RELEASE TABLET

Koostumus:

VALPROATE SODIUM 200 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTIEPILEPTICS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2007-03-02

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM® CHRONO 200MG, 300MG AND 500MG PROLONGED RELEASE 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 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. Do not pass it on to
others. It may harm
them even if their symptoms 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.
What Epilim Chrono is

Valmisteyhteenveto

Page
1
of
23
_▼_
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 tablet.
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).
_ _
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2
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23
FEMALE CHILDREN AND WOMEN OF CHILDBEARING POTENTIAL
Epilim must be initiated and supervised by a specia