CANESTEN CREAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLOTRIMAZOLE

Available from:

BAYER ISRAEL LTD

ATC code:

D01AC01

Pharmaceutical form:

CREAM

Composition:

CLOTRIMAZOLE 1 %W/W

Administration route:

TOPICAL

Prescription type:

Not required

Manufactured by:

GP GRENZACH PRODUKTIONS GMBH, GERMANY

Therapeutic area:

CLOTRIMAZOLE

Therapeutic indications:

For the treatment of fungal infections of the skin and mucosa caused by dermatophytes, yeasts, moulds and other fungi such as Malassezia furfur as well as skin infections caused by Corynebacterium minutissimum. Indicated also for Candida vulvitis and Candida balanitis.

Authorization date:

2020-06-21

Patient Information leaflet

ИНСТРУКЦИЯ ПО ПРИМЕНЕНИЮ ПРЕПАРАТА, В
СООТВЕТСТВИИ С
«ПОЛОЖЕНИЕМ О ФАРМАЦЕВТАХ
(ПРЕПАРАТЫ)» - 1986
Лекарство продается без рецепта врача
КАНЕСТЕН
®
Крем
Активное вещество:
Клотримазол 1% (Clotrimazole 1%)
СПИСОК НЕАКТИВНЫХ ВЕЩЕСТВ ПРЕПАРАТА И
АЛЛЕРГЕНОВ: см. раздел 2 «Важная
информация о некоторых ингредиентах
препарата» и раздел 6 «Дополнительная
информация».
ПРЕЖДЕ ЧЕМ НАЧАТЬ ПРИМЕНЕНИЕ
ПРЕПАРАТА, ВНИМАТЕЛЬНО ПРОЧТИТЕ
ИНСТРУКЦИЮ ДО КОНЦА. Инструкция
содержит краткую информацию о
препарате.
Если у вас есть дополнительные
вопросы, обратитесь к врачу или
фармацевту.
Вам необходимо применять данный
препарат согласно указаниям в пункте
дозировки настоящей инструкции. Если
вам потребуется дополнительная
информация, проконсультируйтесь у
фармацевта. Если симптомы вашего
заболевания усугубились или не
улучшились в течение 4 недель, то вам
следует
обратиться к врачу.
1)
ДЛЯ ЧЕГО ПРИМЕНЯЮТ ДАННЫЙ ПРЕПАРАТ?
Канестен
Крем предназначен для лечения
инфекций кожи и слизистых
оболочек, вызываемых различными
видами грибка. Также предназначен для
лечения кандидоза влагалища и
кандидоза полового члена.
ТЕРАПЕВТИЧЕСКАЯ Г

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Canesten Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w.
Excipients with known effect: Cetostearyl alcohol 100mg in each gram
of cream,
benzyl alcohol 20 mg in each gram of cream.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A white cream for topical use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of fungal infections of the skin and mucosa caused
by dermatophytes,
yeasts, moulds and other fungi such as Malassezia furfur as well as
skin infections caused by
Corynebacterium minutissimum. Indicated also for Candida vulvitis and
Candida balanitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
There is no separate dosage schedule for the young or elderly.
The cream should be applied thinly 2-3 times daily and rubbed in
gently. A strip of cream (½
cm long) is enough to treat an area of about the size of the hand.
Treatment should be
continued for at least one month for dermatophyte infections and at
least two weeks for
candidal infections.
If the feet are infected, they should be washed and dried, especially
between the toes,
before applying the cream.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1. Do not
use the cream to treat nail or scalp infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product contains cetostearyl alcohol, which may cause local skin
reactions (e.g. contact
dermatitis). The cream also contains benzyl alcohol which may cause
allergic reactions and mild local irritation.
Instruct patients not to smoke or go near naked flames - risk of
severe burns. Fabric (clothing,
bedding, dressings etc) that has been in contact with this product
burns more easily and is a
serious fire hazard. Washing clothing and bedding may reduce product
build-up but not
totally remove it.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Laboratory tests have suggested that, when used together, this product
may cause da