Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Clotrimazole
LTT Pharma Limited
D01AC; D01AC01
Clotrimazole
1 percent
Cream
Product not subject to medical prescription
Imidazole and triazole derivatives; clotrimazole
Authorised
2016-11-11
CANESTEN CREAM (clotrimazole 1% w/w) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Canesten Cream carefully to get the best results from it. * Keep this leaflet. You may need to read it again. * Ask your pharmacist if you need more information or advice. * You must contact a doctor if your symptoms worsen or do not improve. * If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET What is Canesten Cream and what is it used for? Before you use Canesten Cream How to use Canesten Cream Possible side effects How to store Canesten Cream Further information WHAT IS CANESTEN CREAM AND WHAT IS IT USED FOR? Canesten Cream is used to treat fungal skin infections such as ringworm, athlete's foot, fungal nappy rash and fungal sweat rash. lt is also used to relieve irritation of the vulva (external thrush) or the end of the penis, which may be associated with thrush. LF 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. 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 of Canesten Cream. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS: This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). SPECIAL PRECAUTIONS: As with other creams, Canesten Cream may reduce the effectiveness of rubber contraceptives, such as condoms or diaphragms. Consequently, if you are using this cream on the vulva or penis, you should use alternative precautions for at least five days Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains clotrimazole 1% w/w (equivalent to 10mg/g). Excipients with known effect: cetostearyl alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream _Product imported from the United Kingdom_ 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 Benzyl alcohol Polysorbate 60 Sorbitan Stearate Cetyl Palmitate Cetostearyl alcohol Octyldodecanol Purified water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the tube and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package. 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_ _ _ _1_ _4_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _2_ _5_ _9_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Tubes with screw on caps containing 20 g cream. Each tube is contained within a cardboard carton. 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 Medicines should not be disposed of via wastewater or household waste. Ask your pharm Citiți documentul complet