Canesten Plus

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clotrimazole 10 mg/g; Hydrocortisone acetate 11.2 mg/g equivalent to hydrocortisone 10 mg;  

Available from:

Bayer New Zealand Limited

INN (International Name):

Clotrimazole 10 mg/g

Pharmaceutical form:

Topical cream

Composition:

Active: Clotrimazole 10 mg/g Hydrocortisone acetate 11.2 mg/g equivalent to hydrocortisone 10 mg   Excipient: Benzyl alcohol Cetostearyl alcohol Hydrochloric acid Triceteareth-4-phosphate Medium-chain triglycerides Purified water Sodium hydroxide

Units in package:

Tube, aluminium, with inner lacquer & tube sealing, white polyethylene screw cap, 15 g

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Bayer Hispania SL

Therapeutic indications:

CANESTEN PLUS cream is indicated for dermatophyte and yeast infections of the skin when inflammation is prominent. This includes conditions such as fungal infected dermatitis, intertrigo and Candida nappy rash.

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, with inner lacquer & tube sealing, white polyethylene screw cap - 15 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, with inner lacquer & tube sealing, white polyethylene screw cap - 20 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, with inner lacquer & tube sealing, white polyethylene screw cap - 30 g - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2011-02-16

Patient Information leaflet

_Canesten Plus CMI _
_16 May 2016_
Consumer Medicine Information
1
CANESTEN
®
PLUS
TOPICAL CREAM – CLOTRIMAZOLE 10 MG/G & HYDROCORTISONE 10 MG/G
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CANESTEN PLUS
Clotrimazole and
Hydrocortisone Cream.
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 pharmacist has weighed the
risks of you using
CANESTEN PLUS cream 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 PLUS CREAM USED FOR?
CANESTEN PLUS cream is used on the skin to treat and soothe inflamed
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 PLUS cream is a broad spectrum anti-fungal and
anti-inflammatory cream. It
contains two active ingredients; clotrimazole and hydrocortisone (as
acetate).
Clotrimazole belongs to a group of medicines called imidazole
antifungals which are used to
treat fungal skin infections. Hydrocortisone is a mild steroid which
reduces the swelling,
redness and itching associated with inflammation of the skin.
_Canesten Plus CMI _
_16 May 2016_
Consumer Medicine Information
2
For conditions without inflammation use an antifungal agent without
hydrocortisone, such as
Canesten clotrimazole antifungal cream.
This product should only be used in children under 2 years of age (for
example, fungal nappy
rash) if a doctor has told you to.
ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHETHER
THIS MEDICINE
IS SUITABLE FOR YOU.
CANESTEN PLUS is a Pharmacist Only Medicine. This medicine is
available without a
doctor’s prescription, only through your pharmacist.
BEFORE USING CANESTEN PLUS CREAM
_WH

Summary of Product characteristics

_Canesten Plus Data Sheet _
_20 November 2012_
NEW ZEALAND DATA SHEET
Page 1 of 6
CANESTEN
®
PLUS
TOPICAL CREAM
CLOTRIMAZOLE 10 MG/G, HYDROCORTISONE ACETATE 11.2 MG/G
QUALITATIVE AND QUANTITATIVE COMPOSITION
CANESTEN PLUS Clotrimazole and Hydrocortisone Cream contains 10 mg/g
of clotrimazole
and 11.2 mg/g of hydrocortisone acetate (equivalent to 10 mg/g
hydrocortisone) as active
ingredients.
PHARMACEUTICAL FORM
Cream – topical.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
CANESTEN PLUS cream is indicated for dermatophyte and yeast infections
of the skin when
inflammation is prominent. This includes conditions such as fungal
infected dermatitis,
intertrigo and Candida nappy rash.
POSOLOGY AND METHOD OF ADMINISTRATION
A small amount of CANESTEN PLUS cream should be applied thinly and
evenly with gentle
rubbing to the affected area(s) twice daily. Use only until
inflammation, itching and redness
have subsided, and not for more than 7 days (unless directed by the
doctor). Then use an
antifungal-only cream such as CANESTEN Clotrimazole Anti-fungal Cream
for 14 days after
symptoms disappear to avoid recurrence of the infection.
CONTRAINDICATIONS
CANESTEN PLUS cream is contraindicated in the following cases:

hypersensitivity to the active substances or to any of the excipients
listed in
Pharmaceutical Particulars

use on broken skin

diseases affecting the skin (such as acne, rosacea, perioral
dermatitis, lues,
tuberculosis, etc.)

in or near the eyes

viral skin diseases (e.g. herpes simplex, chicken pox, etc.)

dermal vaccination reactions
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Because of its corticosteroid content, CANESTEN PLUS cream should not
be applied to large
areas (more than 10% of the body surface) and/or under occlusive
dressings (such as
nappies and bandages) because this may increase absorption.
_Canesten Plus Data Sheet _
_20 November 2012_
Page 2 of 6
The effectiveness and safety of latex products such as condoms and
diaphragms may be
reduced by CANESTEN PLUS cream when applied on