DEPAKINE 200mg/ml oral solution

Country: Egypt

Language: English

Source: EDA (Egyptian Drug Authority)

Available from:

SANOFI AVENTIS-EGYPT

Dosage:

200 mg/ml

Pharmaceutical form:

syrup

Units in package:

40 ml

Manufactured by:

SANOFI WINTHROP-FRANCE

Authorization date:

2004-06-15

Patient Information leaflet

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WHAT IS IN THIS LEAFLET :
1. What Depakine is and what it is used for
2. What you need to know before you take
Depakine
3. How to take Depakine
4. Possible side effects
5. How to store Depakine
6. Further Information. 1. WHAT DEPAKINE IS AND WHAT IT IS USED
FOR
Depakine belongs to a family of medicines called
antiepileptics.
This medicine is used to treat various types of
seizures in adults and children. It is also used in
children to prevent fever-related seizures. 2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DEPAKINE
CONTRA-INDICATIONS:
NEVER TAKE DEPAKINE 200 MG/ML ORAL SOLUTION:
-
if you are allergic to the active substance of this
medicine (sodium valproate) or to any of the
other ingredients in Depakine. 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 have hepatic porphyria (hereditary liver
disease),
-
if you have a genetic problem causing a
mitochondrial disorder (e.g. Alpers-Huttenlocher
syndrome),
-
if you are currently taking the following
medicines:
• mefloquine (medicine used to treat malaria),
• St. John’s Wort (plant used to treat depression).
APPROPRIATE PRECAUTIONS FOR USE; SPECIAL WARNINGS
This medicine can, in very rare cases, cause
liver damage (hepatitis) or pancreas damage
(pancreatitis), which can be serious and
life-threatening.
Your doctor will prescribe blood tests to
regularly monitor your liver function,
particularly during the first 6 months of
treatment.
Inform your doctor immediately if any of the
following signs appear:
- sudden fatigue, loss of appetite, exhaustion,
drowsiness, swelling of the legs, general
malaise,
- repeated vomiting, nausea, stomach or bowel
pain, yellow color of the skin or eyes (jaundice).
- recurrence of epileptic seizures even th

Summary of Product characteristics

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