Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CREAM
**How should Canesten® Plus Antifungal Cream be used?** Apply Canesten® Plus Antifungal Cream thinly to the affected skin area once a day or twice a day (in the morning and evening) and rub it in gently. Use Canesten® Plus Antifungal Cream only until inflammation, itching and redness have subsided, and for a maximum of 7 days (unless otherwise directed by your doctor). Then continue treatment with an Antifungal Cream without hydrocortisone (eg. Canesten® cream 1%) for 14 days after symptoms have subsided to avoid recurrence of the infection.
TOPICAL
Medical Information
**What is Canesten® Plus Antifungal Cream used for?** Canesten® Plus Antifungal Cream is a topical antifungal cream used to treat skin infections with co-existing symptoms of inflammation, e.g. itching, which rapid symptom relief is desired. Canesten® Plus Antifungal Cream is effective against: - Dermatomycoses caused by dermatophytes (e.g. athlete’s foot), yeasts (e.g. candida intertrigo), moulds, and other fungi - Infections of the vaginal areas caused by yeast fungi (candida vulvitis); inflammation of the penis area caused by yeast fungi (candida balanitis) - Skin diseases superinfected with organisms sensitive to clotrimazole If you are not sure whether you should start using Canesten® Plus Antifungal Cream, talk to your doctor or pharmacist.
**When should you not use Canesten® Plus Antifungal Cream?** Do not use Canesten® Plus Antifungal Cream if: - You are allergic or hypersensitive to any of the ingredients in this product (cetostearyl alcohol may cause local skin reactions, e.g. contact dermatitis) - The affected area of skin is broken - You have other conditions affecting the skin (e.g. acne, rosacea, perioral dermatitis, lues/syphilis, tuberculosis, etc.) - You have a viral skin condition (e.g. cold sores, herpes simplex, chickenpox, etc.) - You currently have skin reaction as a result of a vaccination
D01AC20
imidazoles/triazoles in combination with corticosteroids
Manufacturer Information
BAYER (SOUTH EAST ASIA) PTE LTD
Kern Pharma, S.L.
Active Ingredients
Documents
Patient Information Leaflets
1.4.4 PIL_proposed.pdf
Approved: January 10, 2020