Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Clotrimazole; Hydrocortisone
IMED Healthcare Ltd.
D01AC; D01AC01
Clotrimazole; Hydrocortisone
1.0 / 1.0 percent weight/weight
Cream
Product subject to prescription which may be renewed (B)
Imidazole and triazole derivatives; clotrimazole
Authorised
2011-09-02
PACKAGE LEAFLET: INFORMATION FOR THE USER CANESTEN HC CREAM CLOTRIMAZOLE 1.0% W/W HYDROCORTISONE 1.0% W/W 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. 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 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. 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 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 your face, eyes, mout Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten HC Cream Clotrimazole 1.0%w/w Hydrocortisone 1.0%w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The cream contains 1% w/w of clotrimazole and 1% w/w of hydrocortisone. Also contains cetostearyl alcohol. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream _Product imported from the UK_ A white to pale-yellow cream. 4 CLINICAL PARTICULARS As per PA1410/040/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/040/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Benzyl alcohol Cetostearyl alcohol Medium chain triglycerides Triceteareth-4 phosphate Purified water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer carton of the product on the market in the country of origin. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _3_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _2_ _9_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original carton. 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium tube with internal lacquer coating and HDPE screw-on cap in an over-labelled cardboard carton. Pack size: 30 g 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISA Citiți documentul complet