VALPORAL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

VALPROIC ACID AS SODIUM

Available from:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC code:

N03AG01

Pharmaceutical form:

SYRUP

Composition:

VALPROIC ACID AS SODIUM 200 MG / 5 ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

VALPROIC ACID

Therapeutic area:

VALPROIC ACID

Therapeutic indications:

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

Authorization date:

2010-09-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
VALPORAL SYRUP
Each 5 ml contains:
Sodium
valproate
200 mg
For the list of inactive ingredients, please see section 6.
WARNING
Newborns of mothers who took valproate during
pregnancy are at increased 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 valproate 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 ADDITIONAL REFERENCE,
IF NECESSARY.
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 active ingredient belongs to the
group

Summary of Product characteristics

טמרופ
ןולע
הז
עבקנ
ע
"
י
דרשמ
תואירבה
ונכותו
קדבנ
רשואו
ץרמב
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