Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Clotrimazole
Imbat Limited
G01AF; G01AF02
Clotrimazole
2 percent weight/weight
Vaginal cream
Product not subject to medical prescription
Imidazole derivatives; clotrimazole
Authorised
2016-10-07
PATIENT INFORMATION LEAFLET CANESTEN ® THRUSH 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 THRUSH CREAM CAREFULLY TO GET THE BEST RESULTS FROM IT. Keep this leaflet. You may need to read it again. Ask you 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 Thrush Cream and what is it used for? 2. Before you use Canesten Thrush Cream 3. How to use Canesten Thrush Cream 4. Possible side effects 5. How to store Canesten Thrush Cream 6. Further information and contents of the pack 1. WHAT IS CANESTEN THRUSH CREAM AND WHAT IS IT USED FOR? Canesten Thrush Cream relieves irritation of the vulva (vulvitis) which is caused by vaginal thrush (candidiasis). Although this cream provides relief from the external irritation caused by vaginal thrush, it cannot treat any internal (vaginal) cause of the infection. Ask your doctor or pharmacist to recommend a treatment for this. ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR DOCTOR AS HAVING 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. The active substance in Canesten Thrush 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. 2. BEFORE YOU USE CANESTEN THRUSH CREAM DO NOT USE CANESTEN THRUSH CREAM: If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten Thrush Cream _(see _ _Section 6. Further Information and contents of the pack)_ BEFORE USING CANE Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Thrush Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 20mg clotrimazole (2% w/w) Excipient with know effect: Cetostearyl alcohol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal Cream _Product imported from Spain_ A white oil-in water type cream 4 CLINICAL PARTICULARS As per PA1410/039/012 5 PHARMACOLOGICAL PROPERTIES As per PA1410/039/012 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Benzyl alcohol Polysorbate 60 Sorbitan stearate Cetyl palmitate Cetostearyl alcohol Octyldodeconol Purifed 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 package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions 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_ _1_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _1_ _8_ _4_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Tube (20g) with a screw top. 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 Imbat Ltd, Unit L2 North Ring Business Park Santry Dublin 9 Ireland 8 PARALLEL Lestu allt skjalið