国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
OXYBUTYNIN HYDROCHLORIDE
PCO Manufacturing Ltd.
G04BD; G04BD04
OXYBUTYNIN HYDROCHLORIDE
5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Drugs for urinary frequency and incontinence; oxybutynin
Authorised
2010-08-27
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER DITROPAN ® 5MG TABLETS Oxybutynin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your 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. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Ditropan tablets are and what are they used for 2. What you need to know before you take Ditropan Tablets 3. How to take Ditropan Tablets 4. Possible side effects 5. How to store Ditropan Tablets 6. Contents of the pack and other information 1. WHAT DITROPAN TABLETS ARE AND WHAT THEY ARE USED FOR? WHAT DITROPAN TABLETS ARE Ditropan tablets contain a medicine called oxybutynin hydrochloride. This belongs to two groups of medicines called ‘anticholinergics’ and ‘antispasmodics’ HOW DITROPAN TABLETS WORK It works by relaxing the muscles of the bladder and stops sudden muscle contractions (spasms). This helps control the release of water (urine). WHAT DITROPAN TABLETS ARE USED FOR Ditropan Tablets can be used to treat: • Loss of control in passing water (urinary incontinence) • Increased need or urgency to pass water (urine) • Night time bedwetting in children 5 years or older, when other treatments have not worked Ditropan Tablets can be used in children 5 years or older to treat: • Loss of control in passing urine (urinary incontinence) • Increased need or urgency to pass urine • Night-time bedwetting, when other treatments have not worked 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DITROPAN TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: • You are allergic (hypersensitive) to oxybutynin hydrochloride or any of the other 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ditropan 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg oxybutynin hydrochloride as the active ingredient. Also contains lactose, anhydrous. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from_ the UK: Pale blue circular tablet with a centre break-line on one side and marked ‘OXB5’ on the reverse. 4 CLINICAL PARTICULARS As per PA0540/146/003 5 PHARMACOLOGICAL PROPERTIES As per PA0540/146/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose, anhydrous Microcrystalline cellulose Calcium stearate Indigo carmine aluminium lake (E132) 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 carton of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 ° C 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_ _ _ _3_ _1_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _2_ _4_ _3_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Packs containing 84 tablets in four foil blister strips of 21 tablets each in an over-labelled outer 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 No special requirements. 7 PARALLEL PRODUCT AUTHORISA 完全なドキュメントを読む