Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone acetate; Clotrimazole
Bayer Plc
D01AC20
Hydrocortisone acetate; Clotrimazole
10mg/1gram ; 10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5010605054310
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not give it to anyone else under any circumstances. • If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET 1. What is Canesten HC Cream and what is it used for? 2. Before you use Canesten HC Cream 3. How to use Canesten HC Cream 4. Possible side effects 5. How to store Canesten HC Cream 6. Further Information 1. WHAT IS CANESTEN ® HC CREAM AND WHAT IS IT USED FOR? Canesten HC Cream is used to treat fungal skin infections when there are additional symptoms of inflammation (such as swelling, redness and itching). Canesten HC Cream treats the fungal skin infection and reduces the swelling and itching caused by it. Canesten HC Cream is used for the treatment of infection and irritation of the vulva or end of the penis (glans) caused by thrush. It is also used to treat nappy rash and fungal infection of the breast fold (intertrigo), as well as infections such as ringworm and athlete’s foot. The active substances in Canesten HC Cream are clotrimazole and hydrocortisone acetate. Clotrimazole belongs to a group of medicines called imidazoles which destroy the fungi and some bacteria that cause skin infections. Hydrocortisone acetate is a mild steroid which reduces swelling, redness and itching associated with inflammation of the skin. 2. BEFORE YOU USE CANESTEN ® HC CREAM DO NOT USE CANESTEN HC CREAM: • If you (or your baby if treating nappy rash) are allergic (hypersensitive) to clotrimazole, hydrocortisone or any of the other ingredients, including cetostearyl alcohol or benzyl alcohol, of Canesten HC Cream. • On areas of broken skin. • On large areas of skin (more than 5-10% of body surface). • For longer than 7 days. • To treat cold sores or acne. • On any untreated bacterial skin infection, Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten HC Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 10mg clotrimazole and 11.2mg hydrocortisone acetate (equivalent to 10mg hydrocortisone). Excipients with known effect: cetostearyl alcohol 100mg in each gram of cream, benzyl alcohol 20mg in each gram of cream. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten HC is indicated for the treatment of the following skin infections where co-existing symptoms of inflammation, e.g. itching, require rapid relief: a) All dermatomycoses due to dermatophytes (e.g. Trichophyton species), moulds and other fungi. b) All dermatomycoses due to yeasts (Candida species). c) Skin diseases showing secondary infection with these fungi. d) The treatment of nappy rash where infection due to Candida albicans is present. Candidal vulvitis, candidal balanitis and candidal intertrigo. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Canesten HC Cream should be thinly and evenly applied to the affected area twice daily and rubbed in gently. Treatment should be for a maximum of 7 days. A total daily dose of 10 mg cream per kg body weight should not be exceeded. For an adult weighing 50 kg the maximum daily dose is 500 mg cream which equals approximately 2 cm of cream to be divided into 2 applications per day. There is no separate dosage schedule for the elderly or the young. However, long-term therapy to extensive areas of skin should be avoided particularly in infants and children. Treatment duration: If the acute symptoms have subsided after about 7 days but treatment is still required, this may be carried out with the corticoid-free preparation intended for this purpose. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Use on broken skin - Diseases affecting the skin (e.g. acne, rosacea, perioral dermatitis, lues, t Read the complete document