Canesten

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clotrimazole 1%{relative}; Clotrimazole 1%{relative}

Available from:

Bayer New Zealand Limited

INN (International Name):

Clotrimazole 1% w/w

Dosage:

1 %

Pharmaceutical form:

Topical cream

Composition:

Active: Clotrimazole 1%{relative} Excipient: Benzyl alcohol Cetostearyl alcohol Cetyl palmitate Octyldodecanol Polysorbate 60 Purified water Sorbitan stearate Active: Clotrimazole 1%{relative} Excipient: Benzyl alcohol Cetostearyl alcohol Cetyl palmitate Octyldodecanol Polysorbate 60 Purified water Sorbitan stearate

Units in package:

Jar, plastic, 500 g

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Bayer Hispania SL

Therapeutic indications:

· Tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm of the trunk and limbs) due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis.

Product summary:

Package - Contents - Shelf Life: Jar, plastic, - 500 g - 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 5 g - 24 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C - Tube, aluminium, - 20 g - 48 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C - Tube, aluminium, - 50 g - 48 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C

Authorization date:

1975-03-06

Patient Information leaflet

_Canesten topicals CMI _
_20 July 2015_
Consumer Medicine Information
1
CANESTEN
®
TOPICAL CREAM – CLOTRIMAZOLE 10 MG/G
TOPICAL SOLUTION – CLOTRIMAZOLE 10 MG/ML
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CANESTEN Clotrimazole
topical cream
and topical solution.
It does not contain all the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your pharmacy has weighed the
risks of you using
CANESTEN cream or solution against the benefits they expect it will
have for you.
If you have any concerns about this medicine, ask your doctor or
pharmacist.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT IS CANESTEN CREAM OR SOLUTION USED FOR?
CANESTEN cream and solution is used on the skin to treat and soothe
fungal skin conditions
such as:

Tinea pedis (athlete’s foot)

External symptoms of thrush

Jock itch

Fungally infected nappy rash

Ringworm

Fungal skin rash

Fungally infected eczema or dermatitis.
CANESTEN is a broad spectrum anti-fungal topical cream or solution. It
contains the active
ingredient clotrimazole – 10 mg/g in the cream and 10 mg/mL in the
solution. Generally the
cream presentation is suitable for most infections, but the solution
may be used on parts of
the body that have more hair which makes application of the cream
difficult.
Clotrimazole belongs to a group of medicines called imidazole
antifungals which are used to
treat fungal skin infections.
_Canesten topicals CMI _
_20 July 2015_
Consumer Medicine Information
2
ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHETHER
THIS MEDICINE
IS SUITABLE FOR YOU.
CANESTEN cream and solution are Pharmacy Only Medicines. They are
available without a
doctor’s prescription, only through your pharmacy.
BEFORE USING CANESTEN CREAM OR SOLUTION
_WHEN YOU MUST NOT USE IT _
DO NOT USE CANESTEN CREAM OR SOLUTION IF:
1.
YOU HAVE AN ALLERGY TO ANY OF THE INGREDIENTS OF CANESTEN CREAM OR
SOLUTIO

Summary of Product characteristics

_ _
_Canesten Data Sheet _
_4 April 2022_
NEW ZEALAND DATA SHEET
Page 1 of 9
RESTRICTED
CANESTEN
®
CANESTEN CLOTRIMAZOLE THRUSH 6 DAY CREAM, INTERNAL VAGINAL CREAM 10
MG/G (1%)
CANESTEN CLOTRIMAZOLE THRUSH 3 DAY CREAM, INTERNAL VAGINAL CREAM 20
MG/G (2%)
CANESTEN CLOTRIMAZOLE THRUSH 1 DAY CREAM, INTERNAL VAGINAL CREAM 100
MG/G (10%)
CANESTEN CLOTRIMAZOLE THRUSH 6 DAY PESSARY, VAGINAL PESSARY 100 MG
CANESTEN CLOTRIMAZOLE THRUSH 1 DAY PESSARY, VAGINAL PESSARY 500 MG
CANESTEN CLOTRIMAZOLE THRUSH 1 DAY PESSARY & CREAM, VAGINAL PESSARY
500 MG +
TOPICAL CREAM 10 MG/G (1%)
1.
NAME OF THE MEDICINAL PRODUCT
Clotrimazole
1-(o-chloro- α, α - diphenylbenzyl) imidazole
C
22
H
17
ClN
2
Molecular Weight 344.84
Clotrimazole is a colourless, crystalline, weakly alkaline substance,
melting point 141°- 145°C, soluble in
acetone, chloroform and ethanol and practically insoluble in water. It
forms stable salts with both organic and
inorganic acids. It is not photosensitive but is slightly hygroscopic,
and may be hydrolysed in acid media.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT
All formulations: clotrimazole
_Canesten Data Sheet _
_4 April 2022_
Page 2 of 9
RESTRICTED
QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT
Canesten Clotrimazole Thrush 6 Day Cream contains 10 mg/g (1% w/w) of
clotrimazole in a vanishing cream
base.
Canesten Clotrimazole Thrush 3 Day Cream contains 20 mg/g (2% w/w) of
clotrimazole in a vanishing cream
base.
Canesten Clotrimazole Thrush 1 Day Cream contains 100 mg/g (10% w/w)
of clotrimazole in a vanishing cream
base
Canesten Clotrimazole Thrush 6 Day Pessary contains 100 mg of
clotrimazole in each pessary.
Canesten Clotrimazole Thrush 1 Day Pessary contains 500 mg of
clotrimazole in each pessary.
Canesten Clotrimazole Thrush 1 Day Pessary & Cream contains 500 mg of
clotrimazole in each pessary and 10
mg/g clotrimazole in the cream.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
CANESTEN CLOTRIMAZOLE THRUSH 6 DA