Consumer medicine information

Before using this product

Please read this leaflet carefully.

If you have any further questions or are not sure about something, ask your pharmacist.

This leaflet is only a summary

1. PRODUCT DESCRIPTION

CANESTEN ONCE DAILY BIFONAZOLE cream is a white opaque cream presented in a screw-cap tube containing 20g of cream.

Each gram of CANESTEN ONCE DAILY BIFONAZOLE 1% cream contains 10 mg of bifonazole.

The cream also contains benzyl alcohol, cetyl esters wax, cetostearyl alcohol, octyldodecanol, polysorbate 60, sorbitan monostearate and purified water.

Pack size: Cream tube 20g

2. WHAT CANESTEN ONCE DAILY BIFONAZOLE CREAM IS USED FOR

CANESTEN ONCE DAILY BIFONAZOLE cream is a topical antifungal cream used to treat skin infections such as tinea, Athlete's foot, jock itch, ringworm of the body and other skin infections caused by fungi and yeasts (eg. skin infections which may be associated with nappy-rash).

The product contains the active ingredient bifonazole and is for external use only.

3. BEFORE YOU USE CANESTEN ONCE DAILY BIFONAZOLE CREAM

NOT RECOMMENDED FOR USE ON BABIES EXCEPT UNDER MEDICAL SUPERVISION.

Do not use CANESTEN ONCE DAILY BIFONAZOLE cream:

• if you are allergic to bifonazole or any of the ingredients,
• in the eyes,
• past its expiry date.

Ask your pharmacist or doctor for advice

• before treating yourself, as many skin infections have similar signs and symptoms,
• before treating a baby,
• if you are pregnant or breastfeeding,
• if you are using other things to treat your skin condition, including other medicines, creams or ointments you may have bought at your pharmacy, supermarket or health food shop.

Not to be taken orally. Not for internal use.

CANESTEN ONCE DAILY BIFONAZOLE cream is not to be used for fungal infections of mucosal membranes, eg. in the mouth or vagina.

4. HOW TO USE CANESTEN ONCE DAILY BIFONAZOLE CREAM

Apply CANESTEN ONCE DAILY BIFONAZOLE cream once a day, preferably before going to bed.

Clean and dry the affected area thoroughly. Apply cream thinly to the affected area and rub in gently. A small amount (about the size of a pea) is sufficient for the treatment of an area about the size of the palm.

The length of treatment is between 2 to 4 weeks and depends on the type of infection and site involved.

To achieve a lasting cure, continue applying the cream for the full duration of treatment as shown below, even if the infection seems to have cleared.

Athlete's foot or tinea of the foot
3 weeks

Yeast infections o the skin
2 - 4 weeks

Jock itch, Ringworm or tinea of the body
2 - 3 weeks

Missed Application

If you miss an application, apply it as soon as you remember. However if it is almost time for your next application ignore the missed dose and go back to using it as you would normally.

In case of swallowing

Seek medical advice immediately or contact the Poisons Information Centre (tel: 131126).

5. WHILE YOU ARE USING CANESTEN ONCE DAILY BIFONAZOLE CREAM

Attention to hygiene is important in the management of fungal infections of the feet. After washing the feet, dry thoroughly (especially between the toes) with a clean towel. Wear clean cotton socks and change daily or more often if your feet sweat freely. Wear well-ventilated shoes or sandals.

Wear loose fitting cotton clothing when using this medication on the groin area.

In general, keep the affected areas clean, cool and dry.

6. SIDE EFFECTS

Occasionally, skin reactions such as redness, burning, itching, irritation and peeling may occur.

If any of these local reactions (or other side effects not listed above) develop, discontinue use and ask for advice from your pharmacist or doctor.

7. AFTER USING CANESTEN ONCE DAILY BIFONAZOLE CREAM

Continue treatment for the recommended length of time even if the infection seems to have cleared.

Storage

Keep all medicines out of the reach of children.

CANESTEN ONCE DAILY BIFONAZOLE cream should be stored in the manufacturer's tube until immediately before use.

Store below 30°C.

Check the expiry date on the end panel of the carton and on the crimp at the end of the tube. Do not use after the expiry date.

Discard expired medicine out of reach of children.

Further information

You are advised to discuss any aspect of CANESTEN ONCE DAILY BIFONAZOLE cream treatment or seek further information from your pharmacist.

Manufacturer:

BAYER AUSTRALIA LTD
A.C.N. 000 138 714
875 Pacific Highway
PYMBLE NSW 2073

Date of preparation: March 1998

Published by MIMS August 2001

Name of the medicine

Bifonazole.

Excipients

Description

Chemical name: 1-(α-biphenyl-4-ylbenzyl)imidazole. Molecular formula: C₂₂H₁₈N₂. MW: 310.4. CAS:60628-96-8. Melting point: 145 to 151°C. Bifonazole is a white, crystalline powder. It is practically insoluble in water, very soluble in methylene chloride and methanol, freely soluble in acetone, dimethyl sulphoxide and dimethyl formamide.
Bifonazole is photosensitive, thermostable, oxygen stable and not hygroscopic; it is stable within the acid and alkaline ranges (pH < 1 to > 12).

Actions

Broad-spectrum antifungal.

Pharmacology

Bifonazole is active against dermatophytes, yeasts and Malassezia furfur. Its in vitro activity against dermatophytes (e.g. Trichophyton spp.) is fungicidal, whereas that against yeasts is primarily fungistatic.
The measurement of radioactivity in various layers of excised skin sections after topical application of ¹⁴C-labelled bifonazole as 1% solution for six hours under occlusive dressing indicated that minimum inhibitory concentrations for most susceptible fungi were achieved in the epidermis (1,000 microgram/cm³ in the superficial layers decreasing to 20 microgram/cm³ in the deeper layers) and as deep as the middle region of the dermis (2 to 3 microgram/cm³).
In infection prophylaxis studies designed to estimate the cutaneous retention time of bifonazole in a guinea pig model, bifonazole cream had intradermal activity lasting for 48 to 72 hours.
When 1% bifonazole cream was applied topically on a 200 cm² surface area for six hours under occlusive dressing, between 2 and 4% of the applied dose was absorbed from inflamed skin, and about 1% of the dose was absorbed from healthy intact skin. Maximum plasma bifonazole concentration amounted to 3 to 8 nanogram/mL after a single application to inflamed skin and 1 to 2 nanogram/mL after a single application to healthy skin. Following two to four weeks of repeated application to healthy skin, plasma bifonazole concentration rose to 2 to 5 nanogram/mL.

Indications

Mycoses of the skin caused by dermatophytes (e.g. Trichophyton spp., Microsporum spp., Epidermophyton floccosum); mycoses of the skin caused by yeasts (e.g. Candida albicans and other yeast species); pityriasis versicolor caused by Malassezia furfur.

Contraindications

Hypersensitivity to bifonazole; in cases of hypersensitivity to cetostearyl alcohol, allergic reactions may occur.

Warnings

Not intended for ophthalmic use.

Precautions

If evidence of local intolerance develops, withdrawal of the drug should be considered with substitution of other appropriate therapy.
The efficacy and safety of Canesten Once Daily Bifonazole Cream in mucosal applications has not been tested. Fungal infections of the mucous membranes should not, therefore, be treated with Canesten Once Daily Bifonazole Cream.

Use in pregnancy.

Use in lactation.

Interactions

None reported.

Adverse Effects

Following cutaneous application of Canesten Once Daily Bifonazole Cream, erythema, burning, pruritus, irritation and scaling have occasionally occurred. Contact dermatitis has been less frequently reported (less than 1%). These side effects are reversible after discontinuation of the treatment.

Directions For Use

Canesten Once Daily Bifonazole Cream is used once daily, preferably before retiring. It is applied thinly to the skin areas affected and rubbed into the skin. A small amount (cream: 0.5 cm line) is sufficient for the treatment of an area about the size of the palm.
To achieve a lasting cure, treatment with Canesten Once Daily Bifonazole Cream should not be stopped when the acute inflammatory symptoms and signs have subsided but, depending on the type of disease, be continued for the periods listed as follows, which give the durations of treatment generally used.
Mycoses of the foot (tinea pedis, tinea pedis interdigitalis): 3 weeks.
Mycoses of the body, hands or skin folds (tinea corporis, tinea cruris, tinea manuum): 2 to 3 weeks.
Pityriasis versicolor: 2 weeks.
Superficial candidiasis of the skin: 2 to 4 weeks.

Overdosage

None reported. In case of accidental swallowing medical advice should be immediately be sought and the Poisons Information Centre contacted on ph: 131126.

Presentation

Cream, 1%: 5 g, 15 g, 20 g, 30 g, 50 g.

Poison Schedule

S2.