Bifonazole Cream

BIFONAZOLE cream

Before using this product Please read this leaflet carefully.

If you have any further questions or are not sure about something, ask your rmacist. This leaflet is only a summary

1. PRODUCT DESCRIPTION:

BIFONAZOLE cream is a white opaque cream presented in a screwcap tube containing 15g of cream. Each gram of 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 15g

2. WHAT BIFONAZOLE CREAM IS USED FOR

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

3. BEFORE YOU USE BIFONAZOLE CREAM NOT RECOMMENDED FOR USE ON BABIES EXCEPT UNDER MEDICAL SUPERVISION.

Do not use BIFONAZOLE cream: • if you are allergic to bifonazole or any of the ingredients, • in the eyes, • past its expiry date. Ask your rmacist 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 rmacy, supermarket or health food shop. Not to be taken orally. Not for internal use. BIFONAZOLE cream is not to be used for fungal infections of mucosal membranes, eg. in the mouth or vagina.

4. HOW TO USE BIFONAZOLE CREAM

Apply 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 the Poisons Information Centre (tel: 131126).

5. WHILE YOU ARE USING 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 wellventilated 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 rmacist or doctor.

7. AFTER USING 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. 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 BIFONAZOLE cream treatment or seek further information from your rmacist.