País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
LTT Pharma Limited
G04CA; G04CA01
ALFUZOSIN HYDROCHLORIDE
2.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; alfuzosin
Authorised
2014-06-13
XATRAL 2.5MG FILM-COATED TABLETS (alfuzosin 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 any further questions, ask your doctor or pharmacist. * This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: What Xatral 2.5mg Film-coated Tablets is and what it is used for Before you take Xatral 2.5mg Film-coated Tablets How to take Xatral 2.5mg Film-coated Tablets Possible side effects How to store Xatral 2.5mg Film-coated Tablets Further information WHAT XATRAL 2.5MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR The name of your tablet is Xatral. It contains a medicine called alfuzosin hydrochloride. This belongs to a group of medicines called alpha-blockers. Xatral 2.5mg Film-coated Tablets can be used to treat the symptoms of Benign Prostatic Hypertrophy (BPH). This is when the prostate gland enlarges (hypertrophy) but the growth is not cancerous (it is benign). It can cause problems in passing water (urine). This happens mainly in older men. * The prostate gland lies underneath the bladder. It surrounds the urethra. This is the tube that takes your water to the outside of the body. * If the prostate gets bigger, it presses on the urethra making it smaller. This makes it difficult to pass water. * Your tablets work by relaxing the prostate gland muscle. This allows the urethra to get bigger and so makes it easier to pass water. BEFORE YOU TAKE XATRAL 2.5MG FILM-COATED TABLETS DO NOT TAKE XATRAL 2.5MG FILM-COATED TABLETS IF: * You are allergic (hypersensitive) to alfuzosin or any of the other ingredients of Xatral (see section 6: Further Information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, throat, or tongue. * Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xatral 2.5mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5mg alfuzosin hydrochloride. Excipients: Also contains Lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-Coated Tablet. _Product imported from UK_ White round, film coated tablet engraved on one side with ‘Xatral 2.5’. 4 CLINICAL PARTICULARS As per PA0540/162/001 5 PHARMACOLOGICAL PROPERTIES As per PA0540/162/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS TABLET CORE Microcrystalline cellulose Lactose Povidone Sodium starch glycollate Magnesium stearate. COATING Methylhydroxypropylcellulose Polyethylene glycol 400 Titanium dioxide suspension (E171). 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister 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_ _ _ _0_ _5_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _4_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _2_ _9_ _3_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. Store in the original package. 6.5 NATURE AND CONTENTS OF CONTAINER Boxes with 60 tablets in PVC/foil blister strips. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODU Leia o documento completo