Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Betamethasone
PCO Manufacturing Ltd.
D07AC; D07AC01
Betamethasone
1 (0.1%) milligram(s)/gram
Cutaneous foam
Product subject to prescription which may be renewed (B)
Corticosteroids, potent (group III); betamethasone
Authorised
2008-02-22
_ _ PACKAGE LEAFLET: INFORMATION FOR THE USER BETTAMOUSSE ® 1MG/G (0.1%) CUTANEOUS FOAM Betamethasone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet, Bettamousse 1mg/g (0.1%) cutaneous foam will be called Bettamousse. WHAT IS IN THIS LEAFLET: 1. What Bettamousse is and what it is used for 2. What you need to know before you use Bettamousse 3. How to use Bettamousse 4. Possible side effects 5. How to store Bettamousse 6. Contents of the pack and other information 1. WHAT BETTAMOUSSE IS AND WHAT IT IS USED FOR Bettamousse contains the active substance Betamethasone as valerate. Bettamousse belongs to a group of medicines called corticosteroids (‘steroids’ for short). Bettamousse is used to treat skin disorders of the scalp such as psoriasis (raised red patches of skin covered in silvery scales) that may feel itchy, tight or sore. Bettamousse works by reducing inflammation (redness, itching and soreness). It is important to use this medicine to prevent damage to the skin and infections from developing. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETTAMOUSSE DO NOT USE BETTAMOUSSE: If you are allergic to betamethasone valerate or any of the other ingredients of this medicine (listed in section 6). Some of these ingredients (stearyl alcohol, cetyl alcohol and propylene glycol) may cause local skin reactions (e.g. contact dermatitis). If you have any kind of infection of the scalp, unless this is already being treated On a child under 6 years of age If any of the above applies to you, Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bettamousse 1mg/g (0.1% w/w) Cutaneous Foam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betamethasone 1mg/g (0.1% w/w) as valerate Excipients contains: Cetyl alcohol 1.1% w/w Stearyl alcohol 0.5% w/w Propylene glycol 2.0% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous foam _Product imported from Italy:_ Appearance: White, foam mousse 4 CLINICAL PARTICULARS As per PA 1638/009/001 5 PHARMACOLOGICAL PROPERTIES As per PA 1638/009/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Cetyl alcohol Stearyl alcohol Polysorbate 60 Ethanol Purified Water Propylene glycol Citric acid anhydrous Potassium Citrate Butane/Propane 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 on the market in the country of origin. 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_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _6_ _8_ _9_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Do not refrigerate. 6.5 NATURE AND CONTENTS OF CONTAINER Pressurised container Aluminium can with clear cover cap, with a net weight of 100g. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Unit 10, Ashbourne Business Park Rath Прочетете целия документ