Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Clotrimazole
PCO Manufacturing Ltd.
D01AC; D01AC01
Clotrimazole
10 milligram(s)/gram
Cream
Product not subject to medical prescription
Imidazole and triazole derivatives; clotrimazole
Authorised
2000-04-14
_ _ _ _ _ _ _ _ _ _ _ _ PATIENT LEAFLET: INFORMATION FOR THE USER CANESTEN ® 10 MG/G CREAM clotrimazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. Keep this leaflet. You may need to read it again. – Ask your pharmacist if you need more information or advice. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. – You must contact a doctor if your symptoms worsen or do not improve. WHAT IS IN THIS LEAFLET 1. What is Canesten Cream and what is it used for 2. What you need to know before you use Canesten Cream 3. How to use Canesten Cream 4. Possible side effects 5. How to store Canesten Cream 6. Contents of the pack and other information 1. WHAT IS CANESTEN CREAM AND WHAT IT IS USED FOR Canesten Cream is used to treat fungal skin infections such as ringworm, athlete’s foot, fungal nappy rash and fungal sweat rash. It is also used to relieve irritation of the vulva (external thrush) or the end of the penis, which may be associated with thrush. IF YOU ARE UNSURE WHETHER YOU (OR YOUR BABY IF TREATING NAPPY RASH) HAVE ONE OF THESE FUNGAL SKIN INFECTIONS, SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST. The active substance in Canesten Cream is clotrimazole. Clotrimazole belongs to a group of medicines called imidazoles and is an antifungal agent which fights the cause of fungal skin infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN CREAM DO NOT USE CANESTEN CREAM If you (or your baby if treating nappy rash) are allergic (hypersensitive) to clotrimazole or any of the other ingredients including cetostearyl alcohol or benzyl alcohol, of Canesten Cream (listed in section 6). CANESTEN CREAM CONTAINS CETOSTEARYL ALCOHOL AND BENZYL ALCOHOL. This product contains cetostearyl alcohol which may cause local skin irritation (e.g. rash, itching o Preberite celoten dokument
Health Products Regulatory Authority 23 August 2022 CRN00D05N Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten 10 mg/g Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 10 mg clotrimazole equivalent to 1% w/w. Excipient(s) with known effect: cetostearyl alcohol and benzyl alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. _Product imported from Greece and Portugal_ A white oil-in water type cream. 4 CLINICAL PARTICULARS As per PA1410/039/002 5 PHARMACOLOGICAL PROPERTIES As per PA1410/039/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sorbitan Stearate Polysorbate 60 Cetyl Palmitate Cetostearyl alcohol 2-Octyldodecanol Benzyl alcohol Purified water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date on the container and outer package of the product in the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium tubes with screw on caps containing 20 g of cream. Each tube is contained within a cardboard carton. Health Products Regulatory Authority 23 August 2022 CRN00D05N Page 2 of 2 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/048/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 April 2000 Date of last renewal: 14 April 2010 10 DATE OF REVISION OF THE TEXT August 2022 Preberite celoten dokument