CANESTEN CREAM

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

CLOTRIMAZOLE

MAH:

BAYER ISRAEL LTD

ATC_code:

D01AC01

pharmaceutical_form:

CREAM

composition:

CLOTRIMAZOLE 1 %W/W

administration_route:

TOPICAL

prescription_type:

Not required

manufactured_by:

KERN PHARMA S.L, SPAIN

therapeutic_group:

CLOTRIMAZOLE

therapeutic_area:

CLOTRIMAZOLE

therapeutic_indication:

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:

2018-02-28

PIL

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed without a doctor’s prescription
CANESTEN
®
Cream
Active ingredient:
Clotrimazole 1%
INACTIVE INGREDIENTS AND ALLERGENS: see section 2 under “Important
information about some
of this medicine’s ingredients” and
section 6 “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about the medicine. If you have any
further questions,
consult your doctor or pharmacist.
Use this medicine according to the instructions in the section about
dose in this leaflet.
Consult a pharmacist if you need further information. Contact your
doctor if your
disease symptoms get worse or do not improve within 4 weeks.
1)
WHAT IS THIS MEDICINE INTENDED FOR?
Canesten
®
cream is used to treat skin and mucous membrane infections caused by
various
types of fungi. It is also used to treat candida infection of the
vagina and of the penis.
THERAPEUTIC GROUP: imidazole antifungal agents for local use.
2)
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE:
•
If you are sensitive (allergic) to the active ingredient or to any of
the other ingredients
in
this
medicine,
including
cetostearyl
alcohol
(see
section
6,
“Additional
information”).
•
To treat fungal infection of the nails or on the scalp.
SPECIAL WARNINGS ABOUT USING THE MEDICINE:
Do not smoke or go near a source of naked flames due to the 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. As with other creams, Canesten
®
cream may reduce the
effectiveness of contraceptives made of rubber such as condoms or
diaphragms. If you use
this product in the vagina or on the penis, alternative contraceptives
should be used for at
least 5 days after using this product. If your condition has not
im

SPC

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