VALPORAL CAPSULES

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

VALPROIC ACID

Beschikbaar vanaf:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC-code:

N03AG01

farmaceutische vorm:

CAPSULES

Samenstelling:

VALPROIC ACID 200 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutische categorie:

VALPROIC ACID

Therapeutisch gebied:

VALPROIC ACID

therapeutische indicaties:

Sole or adjunctive therapy in the treatment of simple (petit mal) and complex absence seizures. May also be used adjunctively in patients with multiple seizure types which include absence seizures.

Autorisatie datum:

2010-11-30

Bijsluiter

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
VALPORAL CAPSULES
The active ingredient and its quantity:
Each capsule contains:
Valproic acid 200 mg
For the list of inactive ingredients, please see section 6.
WARNING
Newborns of mothers who took valproic acid during pregnancy are
at higher risk of severe developmental disturbances )approximately
30% to 40% of the cases) and birth defects )approximately 11%
of the cases).
If you are a woman of child-bearing age or if you are pregnant, the
doctor will only prescribe valproic acid for you if other treatments
are not suitable.
Women of child-bearing age should use effective methods of
contraception during the course of treatment with this preparation.
Do not stop using the preparation before first consulting with the
attending doctor. If, despite use of contraception, you become
pregnant unplanned, refer to the attending doctor immediately in
order to discuss options for an alternative treatment, if possible.
IN ADDITION TO THE LEAFLET, VALPORAL ALSO COMES WITH A PATIENT
INFORMATION CARD.
THIS CARD CONTAINS IMPORTANT SAFETY INFORMATION, WHICH YOU MUST
KNOW, BEFORE STARTING AND DURING THE COURSE OF TREATMENT WITH
VALPORAL. READ THE PATIENT INFORMATION CARD AND THE PATIENT LEAFLET
BEFORE STARTING TREATMENT WITH THE PREPARATION. KEEP THE CARD FOR
LATER REFERENCE, IF NEEDED.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE.
Keep this leaflet; you may need to read it again.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them even if it seems to you that their ailment is
similar.
This medicine is not intended for children weighing less than
17 kg.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is an anticonvulsant, given to treat certain types of
epilepsy.
THERAPEUTIC GROUP: the

Productkenmerken

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2016
This leaflet format has been determined by the Ministry of Health and
the content thereof
has been checked and approved on Mar 2016.
PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
VALPORAL CAPSULES
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Valproic acid 200 mg
3. PHARMACEUTICAL FORM
Capsules
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sole or adjunctive therapy in the treatment of simple (petit mal) and
complex absence seizures.
May also be used adjunctively in patients with multiple seizure types
which include absence seizures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
In female children, female adolescents, women of childbearing
potential and pregnant women
Valporal should be initiated and supervised by a specialist
experienced in the management of
epilepsy.
Treatment should only be initiated if other treatments are ineffective
or not tolerated (see Section 4.4
and Section 4.6) and the benefit and risk should be carefully
reconsidered at regular treatment
reviews. Preferably Valporal should be prescribed as monotherapy and
at the lowest effective dose, if
possible as a prolonged release formulation. The daily dose should be
divided into at least two single
doses.
In view of the dosage strength this medicinal product is for use in
adults and children weighing over
than 17 kg only.
Valporal 200 mg capsules are not suitable for children under the age
of 6 years (due to risk of choking)
DOSAGE
The mean dosage is 20 -30 mg/kg per day. However, if seizures are not
brought under control at this
dosage it may be increased and patients must be closely monitored.
− In children, the usual dosage is about 30 mg/kg per day in divided
doses.
− In adults and adolscents, the usual dosage is 20 to 30 mg/kg per
day in divided dose.
− In elderly patients, the dosage should be determined based on the
control of seizures.
The daily dosage should determined based on age an