Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
CLOTRIMAZOLE, HYDROCORTISONE
PCO Manufacturing
D01AC01
CLOTRIMAZOLE, HYDROCORTISONE
1/1 %w/w
Cream
Product subject to prescription which may be renewed (B)
Imidazole and triazole derivatives
Authorised
2010-05-07
_ _ PATIENT INFORMATION LEAFLET CANESTEN ® HC CREAM Clotrimazole 1% w/w Hydrocortisone 1% 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 CR Läs hela dokumentet
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 Clotrimazole and 1% w/w hydrocortisone. Also contains 10% w/w cetostearyl alcohol. For a full list of excipients, see section 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 shall be the date shown on the container and outer package of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. Store in the original container. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 30/11/2015_ _CRN 2170559_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium tube with internal lacquer coating and HDPE screw-on cap in an overlabelled cardboard carton. Pack size: 30g 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 AUTHORISATION HOLDER PCO Manufacturing Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/246/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7th May 2010 10 DATE OF REVISION OF THE TEXT November 2015 HEALTH PROD Läs hela dokumentet