Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Clotrimazole; HYDROCORTISONE ACETATE
Bayer Limited
D01AC; D01AC20
Clotrimazole; HYDROCORTISONE ACETATE
1 %w/w/1 percent weight/weight
Cream
Product subject to prescription which may be renewed (B)
Imidazole and triazole derivatives; combinations
2018-06-29
BCH22002 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CANESTEN HC 1% W/W + 1% W/W CREAM clotrimazole/hydrocortisone 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET 1. What is Canesten HC Cream and what is it used for? 2. What you need to know 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. Contents of the pack and other 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 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. Clotrimazole belongs to a group of medicines called imidazoles, which destroy the fungi and some bacteria that cause skin infections. Hydrocortisone is a mild steroid which reduces swelling, redness and itching associated with inflammation of the skin. 2. WHAT YOU NEED TO KNOW 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 ingre Read the complete document
Health Products Regulatory Authority 27 January 2023 CRN00D4ZL Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten HC 1% w/w + 1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 10 mg clotrimazole (1% w/w) and 11.2 mg hydrocortisone acetate (equivalent to 10 mg hydrocortisone (1% w/w)). Excipient(s) with known effect: each gram of cream contains 100 mg cetostearyl alcohol and 20 mg benzyl alcohol. For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Cream. A white to pale yellow cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten HC Cream is a combination of an antifungal and a corticosteroid, both absorbable through broken skin. It is indicated for the topical treatment of skin infections due to superficial dermatophytes, yeasts, moulds and other fungi sensitive to clotrimazole where co-existing symptoms of inflammation, e.g. itching, require rapid relief. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Canesten HC Cream should be thinly and evenly applied to the affected area twice daily and rubbed in gently. Treatment should be continued for no more than 7 days. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. The following contra-indications apply to the hydrocortisone component: specific bacterial skin diseases (syphilis, tuberculosis), chicken pox, vaccination reactions, perioral dermatitis, viral skin diseases (e.g. herpes simplex, rosacea, shingles), use on broken skin, acne. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE All possibly infected areas should be treated at the same time. Because of its corticosteroid content, Canesten HC should not be applied: To large areas (more than 10% of the body surface) In long term continuous therapy Under occlusive dressing, particularly in infants and children, because of the possibility of adrenocortical suppression. Health Products Regulatory Authority 27 January 2023 CRN00D4ZL Page 2 of 5 This p Read the complete document