Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Clotrimazole
PCO Manufacturing Ltd.
G01AF; G01AF02
Clotrimazole
500mg + 2 percent weight/weight
Pessaries and Cream
Product not subject to medical prescription
Imidazole derivatives; clotrimazole
Authorised
2009-06-25
_ _ _ _ PATIENT INFORMATION LEAFLET CANESTEN ® COMBI PESSARY AND CREAM clotrimazole 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 Combi Pessary & 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 in 7 days. – If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET 1. What is Canesten Combi and what is it used for? 2. Before you use Canesten Combi 3. How to use Canesten Combi 4. Possible side effects 5. How to store Canesten Combi 6. Further information 1. WHAT IS CANESTEN COMBI AND WHAT IS IT USED FOR? Canesten Combi Pessary & Cream is a complete treatment for vaginal thrush because it treats both the internal cause and external symptoms. ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR DOCTOR AS HAVING VAGINAL THRUSH. The active substance in Canesten Combi Pessary & Cream is clotrimazole. Clotrimazole belongs to a group of medicines called azoles and is an antifungal agent which fights the cause of infections such as vaginal thrush. Some women suffer from recurrent attacks of thrush. To reduce the frequency of these attacks, the sexual partner’s penis can be treated with this cream to prevent reinfection, even if they have no symptoms of thrush. 2. BEFORE YOU USE CANESTEN COMBI DO NOT USE CANESTEN COMBI PESSARY & CREAM: If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten Combi Pessary & Cream (see Section 6. Further Information) During your period as it may be less effective. BEFORE USING CANESTEN COMBI PESSARY & CREAM, YOU SHOULD SEE YOUR DOCTOR IF: You are unsure whether you have thrush or this is the first time you have had these symptoms You have had more than two Prečítajte si celý dokument
Health Products Regulatory Authority 10 November 2020 CRN00C0YR Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Combi Pessary & Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The pessary contains clotrimazole 500 mg. Each gram of cream contains 20 mg of clotrimazole (equivalent to 2% w/w) Excipient(s) with known effect: Cetostearyl alcohol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pessary and vaginal cream _Product imported from_ UK: White, convex pessary marked ‘Bayer’ on one side and ‘MU’ on the other side. A white oil-in-water type cream 4 CLINICAL PARTICULARS As per PA1410/039/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/039/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Pessary: Lactose monohydrate Microcrystalline cellulose Lactic acid Maize starch Crospovidone Calcium lactate pentahydrate Magnesium stearate Silica, colloidal anhydrous Hypromellose Cream: Sorbitan stearate Cetyl Palmitate Cetostearyl alcohol Octyldodecanol Benzyl alcohol Purified Water 6.2 INCOMPATIBILITIES Health Products Regulatory Authority 10 November 2020 CRN00C0YR Page 2 of 2 Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container 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 6.5 NATURE AND CONTENTS OF CONTAINER Each pessary is packed into a blister consisting of 25 micrometers PA/45 micrometers soft aluminium/ 60 micrometers PVC and 20 micrometers hard aluminium/7g/m2 heat seal lacquer. The cream is supplied in overlabelled aluminium tubes. Both components are enclosed in an overlabelled 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 pharmacist how to dispose of medicines no longer required. These measures Prečítajte si celý dokument