DEPAKINE CHRONO 500mg scored prolonged release f.c.tab.

Država: Egipt

Jezik: angleščina

Source: EDA (Egyptian Drug Authority)

Dostopno od:

SANOFI AVENTIS-EGYPT

Odmerek:

500 mg

Farmacevtska oblika:

tablet

Enote v paketu:

30 tablets

Izdeluje:

SANOFI WINTHROP-FRANCE

Datum dovoljenje:

2004-03-23

Navodilo za uporabo

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3
PACKAGING ADMINISTRATION : SANOFI AMBARÈS - FRANCE
LIBELLÉ :
NOT DPK C500S CP TC RL X1/XD
ITEM CODE
631743
CREATION DATE
15/02/2016
COUNTRY EXPORT
CODE LAETUS 4143
BASED ON
CRÉATION
BY
I. SOURBE
FORMAT
157X210 TC
COLOR
1
ARTICLE
NOTICE
MODIFICATION DATE
22/02/2016
BRAND MARK LOGO
-
FONTS
OCEAN SANS PRO SAN
PROOF N°
2
BY
I. SOURBE
COUNTRY REQUIREMENT CRX - V4 - 01/2015
FONT SIZE
6PT
THIS ARTWORK PROOF INDICATES COLOUR POSITION ONLY.
PLEASE REFER TO PANTONE COLOUR FORMULA
USED COLOR PRINTABLE:
NO PRINTABLE COLOR:
PANTONE REFLEX BLUE
PLAN
PACKAGE LEAFLET : INFORMATION FOR THE USER
DEPAKINE CHRONO® 500 MG
PROLONGED-RELEASE SCORED FILM-COATED TABLETS
valproic acid and 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.
What is in this leaflet:
1.
What Depakine Chrono is and what it is used for
2.
What you need to know before you take Depakine Chrono
3.
How to take Depakine Chrono
4.
Possible side effects
5.
How to store Depakine Chrono
6.
Further information
1. WHAT DEPAKINE CHRONO IS AND WHAT IT IS USED FOR
Depakine Chrono belongs to a family of medicines called
antiepileptics.
This medicine is used to treat various types of seizures in adults and
children over 6 years of
age and weighing more than 17 kg.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEPAKINE CHRONO
CONTRAINDICATIONS:
NEVER TAKE DEPAKINE CHRONO:
-
if you are allergic to the active substance of this medicine (sodium
valproate) or to any
of the other ingredients in Depakine Chrono. For the list of
ingredients, see Section 6,
-
if you are allergic to a medicine in the same family as valproate
(divalproate,
valpromide),
-
if you have liver disease (acute or chronic hepatitis),
-
if you or a member of your family have ever had serious liver disease,
particularly
related to use of a medicine,
-
if you h

Lastnosti izdelka

1
GUIDE FOR HEALTHCARE PROFESSIONALS
INFORMATION ON THE RISKS OF VALPROATE
(
_DEPAKINE_
_®_
) USE IN FEMALE PATIENTS
AND PREGNANT WOMEN. CONTRACEPTION AND PREGNANCY
PREVENTION
Read this booklet carefully before any prescription of valproate
to female patients.
This booklet is a risk minimization measure part of the
valproate Pregnancy Prevention Program aimed at minimizing
pregnancy exposure during treatment with valproate.
Information about valproate use can also be found on-line at
www.sanofi.com.eg
2
CONTENT
PURPOSE OF THIS GUIDE
EXECUTIVE SUMMARY
1.
INFORMATION ON CONGENITAL MALFORMATIONS AND DEVELOPMENTAL
DISORDERS

Congenital malformations

Developmental disorders
2.
THE ROLE OF DIFFERENT HEALTH-CARE PROFESSIONALS (HCPS)
3.
CONDITIONS OF VALPROATE PRESCRIPTION: PREGNANCY PREVENTION
PROGRAM
4.
TREATMENT OF FEMALE PATIENTS WITH VALPROATE

Female patient – first prescription

Women of childbearing potential who are not planning a pregnancy

Women of childbearing potential who are planning a pregnancy

Women with an unplanned pregnancy
5.
SWITCHING OR DISCONTINUING VALPROATE

Patients with epilepsy
3
PURPOSE OF THIS GUIDE
This Guide for healthcare professionals (HCPs) is an educational tool
part of the
VALPROATE
PREGNANCY PREVENTION PROGRAM
, which targets both healthcare professionals and patients.
Its objective is to provide information about the teratogenic risks
associated with the use of valproate
during pregnancy, the actions necessary to minimize the risks to your
patients, and to ensure your
patient has an adequate level of understanding of the risk.
It provides up-to-date information about the risks of
CONGENITAL MALFORMATIONS
and
NEURO-
DEVELOPMENTAL DISORDERS
in children exposed to valproate during pregnancy.
The nature of the risks for children exposed to valproate during
pregnancy are the same
irrespective of the indication for which valproate has been
prescribed. Therefore, the risk
minimization measures described in this Guide apply to the use of
valproate regardless of
th