LAMISIL ONCE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TERBINAFINE AS HYDROCHLORIDE

متاح من:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC رمز:

D01AE

الشكل الصيدلاني:

SOLUTION

تركيب:

TERBINAFINE AS HYDROCHLORIDE 10 MG/G

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

GSK CONSUMER HEALTHCARE SCHWEIZ AG, SWITZERLAND

المجموعة العلاجية:

OTHER ANTIFUNGALS FOR TOPICAL USE

الخصائص العلاجية:

For the treatment of athlete's foot.

تاريخ الترخيص:

2022-09-30

نشرة المعلومات

_ _
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed without a doctor's prescription
LAMISIL ONCE SOLUTION 10MG/G
ACTIVE INGREDIENT:
TERBINAFINE HYDROCHLORIDE 10 MG/G
INACTIVE INGREDIENTS AND ALLERGENS IN THE PREPARATION - SEE SECTION 6
AND SECTION 2 UNDER THE
TITLE “IMPORTANT INFORMATION ABOUT SOME INGREDIENTS OF THE
MEDICINE”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any other questions, refer
to the doctor or the
pharmacist.
Use the preparation according to the instructions in the dosage
section of this leaflet. Consult the
pharmacist if you need more information. Refer to the doctor if the
symptoms of the disease do not
improve after 7 days.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Treatment of athlete’s foot.
THERAPEUTIC CLASS: Anti-fungal for external use.
The preparation kills the fungi that cause athlete’s foot.
2.
BEFORE USING THE MEDICINE
X DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient terbinafine
hydrochloride or to any one of the other components the medicine
contains (see section 6)
! SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
•
Do not use this product after the expiry date stated on the package.
•
Do not use this product if the tube seal is damaged or if the
packaging does not appear
intact.
•
DO NOT USE THIS MEDICINE IN CHILDREN AND ADOLESCENTS UNDER THE AGE OF
15.
•
TELL THE DOCTOR OR PHARMACIST IF YOU ARE PREGNANT OR PLANNING TO
BECOME PREGNANT.
•
THIS MEDICINE IS NOT SUITABLE FOR:
o
Long term treatment of fungal infection of the soles of the feet and
heels with thick
edges and/or peeling skin
o
Treatment of fungal nail infection (fungus inside or under the nail)
with discoloration
of the nail and change in nail texture (thickening or peeling)
Tell the doctor or pharmacist if you think you may have these
conditions, because you may need
another preparation.
ONLY USE LAMISIL

خصائص المنتج

Page 1
PRODUCT INFORMATION
1.
NAME OF THE PRODUCT
LAMISIL ONCE
2.
Active ingredient
Terbinafine hydrochloride 10mg/g
Chemical structure:
3.
PHARMACEUTICAL FORM
Topical solution.
4.
THERAPEUTIC INDICATIONS
Treatment for athlete's foot.
5. DESCRIPTION
Lamisil once also contains, as excipients, Ethyl alcohol 96% (v/v),
acrylates/octylacrylamide copolymer (e.g. Dermacryl 79), medium chain
triglycerides, hydroxypropylcellulose(e.g. Klucel MF) ,.
6. PHARMACOLOGY
6.1.
PHARMACODYNAMICS
Pharmacotherapeutic group: Antifungal for topical use (ATC code D01A
E15).
Terbinafine is an allylamine with antifungal activity mainly against
dermatophytes.
Terbinafine interferes specifically with fungal sterol biosynthesis at
an early step. This leads to a
deficiency in ergosterol and to an intracellular accumulation of
squalene, resulting in fungal cell
death. Terbinafine acts by inhibition of squalene epoxidase in the
fungal cell membrane. The
enzyme squalene epoxidase is not linked to the cytochrome P450 system.
Terbinafine does not
influence the metabolism of hormones or other drugs.
Page 2
A phase III, randomized, double-blind, placebo-controlled clinical
trial has been conducted to
investigate the efficacy and safety of Lamisil Once in patients aged
12 years and over with tinea
pedis. In this study, 273 patients which were treated with a single
application of Lamisil Once (190
patients) or vehicle (83 patients) according to the directions for use
were analysed for the efficacy.
The primary efficacy variable was the number of patients
‘effectively treated’ (negative microscopy,
negative culture, total clinical signs and symptoms score

2 using a scoring scale of 0-3 for each
individual sign/symptom, with no individual sign/symptom for pustules,
incrustation, vesiculation and
an individual score ≤1 for erythema, desquamation, pruritus,) 6
weeks after treatment. Secondary
efficacy parameters included negative culture, negative microscopy,
negative mycology (both
negative microscopy and negative culture), clinical cure (tota