ESKAZOLE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALBENDAZOLE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

P02CA03

Pharmaceutical form:

TABLETS

Composition:

ALBENDAZOLE 400 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GLAXO SMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LIMITED

Therapeutic group:

ALBENDAZOLE

Therapeutic area:

ALBENDAZOLE

Therapeutic indications:

Albendazole is indicated for the treatment of the following systemic helminth diseases: * Echinococcosis (hydatid disease)Albendazole is indicated for the treatment of liver, lung and peritoneal cysts. Experience with bone cysts and those in the central nervous system and heart is limited. * Cystic echinococcosis (caused by Echinococcus granulosus)Albendazole is used in patients with cystic echinococcosis:1. When surgical intervention is not feasible .2. As a co-adjunct to surgical treatment. 3. Prior to surgical intervention. 4. If preoperative treatment was too short, if spillage has occurred or if viable cysts were found at surgery. 5. Following percutaneous drainage of cysts for diagnostic or therapeutic reasons. * Alveolar echinococcosis (caused by Echinococcus multilocularis)Although its efficacy has not been completely demonstrated in clinical trials, albendazole is used in patients with alveolar echinococcosis in the following situations:1. In inoperable disease, particularly in cases of local or distant metastasis.2. Following palliative surgery.3. Following radical surgery or liver transplantation.

Authorization date:

2014-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with
a physician’s prescription only
ESKAZOLE
EACH TABLET CONTAINS ALBENDAZOLE 400 MG.
For the list of inactive and allergenic ingredients in the
preparation,
see section 2 - “Important information about some of the
ingredients of Eskazole” and section 6 - “Further information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the physician
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
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Eskazole is a medicine with antiprotozoal and antihelmintic activity
against tissue and intestinal parasites, especially indicated for
the treatment of a hydatid cyst.
Eskazole is indicated for the treatment of the following systemic
helminth diseases: echinococcosis or hydatid disease.
Eskazole is indicated for the treatment of hydatid cysts caused
by _Echinococcus granulosus_ and _Echinococcus multilocularis_ in
hydatid disease. Eskazole may be used as first-line therapy in
patients where surgical intervention is not feasible because of
anatomic location or the presence of multiple cysts.
Eskazole is indicated for the treatment of liver, lung and peritoneal
cysts. Eskazole may be used as a co-adjunct to surgical
treatment, both before and after surgery.
THERAPEUTIC GROUP: An antihelmintic medicine, derivatives of
benzimidazole.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙ You are sensitive (allergic) to the active ingredient, or to any
of the additional ingredients contained in the medicine (as
detailed in section 6).
∙ You are pregnant or think you may be pregnant. Women of
child-bearing age are advised to take effective contraceptive
measures during treatment and within one month of
termination of trea

Summary of Product characteristics

Page 1 of 8
Eskazole
1.
NAME OF THE MEDICINAL PRODUCT
Eskazole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of albendazole as active substance.
Excipients with known effect
It contains lactose and Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA
(E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
4.
CLINICAL PARTICULARS
Albendazole is a benzimidazole carbamate with antihelmintic and
antiprotozoal activity against intestinal
and tissue parasites.
4.1. Therapeutic indications
Albendazole is indicated for the treatment of the following systemic
helminth diseases (see section 5.1 for
details about susceptible helminth species):

Echinococcosis (hydatid disease)
Albendazole is indicated for the treatment of liver, lung and
peritoneal cysts. Experience with bone cysts and
those in the central nervous system and heart is limited.
Cystic echinococcosis (caused by Echinococcus granulosus)
Albendazole is used in patients with cystic echinococcosis:
1.
When surgical intervention is not feasible.
2.
As a co-adjunct to surgical treatment.
3.
Prior to surgical intervention.
4.
If preoperative treatment was too short, if spillage has occurred or
if viable cysts were found at surgery.
5.
Following percutaneous drainage of cysts for diagnostic or therapeutic
reasons.
Alveolar echinococcosis (caused by Echinococcus multilocularis)
Although its efficacy has not been completely demonstrated in clinical
trials, albendazole is used in patients
with alveolar echinococcosis in the following situations:
1.
In inoperable disease, particularly in cases of local or distant
metastasis.
2.
Following palliative surgery.
3.
Following radical surgery or liver transplantation.
Page 2 of 8
4.2. Posology and method of administration
Posology
There is limited experience of use of albendazole in children under 6
years of age; therefore use in children
under this age is not recommended.
Dosages are dependent on the parasites involved, the weight of the
patient, and the seriousness of th