Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
ALFUZOSIN HYDROCHLORIDE
IMED Healthcare Ltd.
G04CA; G04CA01
ALFUZOSIN HYDROCHLORIDE
10 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; alfuzosin
Authorised
2009-03-06
PACKAGE LEAFLET INFORMATION FOR THE USER : XATRAL 10MG PROLONGED RELEASE 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 onto 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: 1. What Xatral 10mg Prolonged Release Tablets is and what it is used for 2. Before you take Xatral 10mg Prolonged Release Tablets 3. How to take Xatral 10mg Prolonged Release Tablets 4. Possible side effects 5. How to store Xatral 10mg Prolonged Release Tablets 6. Further information 1. WHAT XATRAL 10MG PROLONGED RELEASE 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 10mg Prolonged Release 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. In a few patients with benign prostatic hypertrophy, the prostate gland gets so big that it stops the flow of urine completely. This is called Acute Urinary Retention. This is very painful and you may need a short stay in hospital A Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xatral 10mg Prolonged Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg alfuzosin hydrochloride For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet, prolonged release. _Product imported from the UK and Italy_: Round biconvex three layer tablet; one white layer between two yellow layers. 4 CLINICAL PARTICULARS As per PA0540/162/003 5 PHARMACOLOGICAL PROPERTIES As per PA0540/162/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Ethylcellulose Hydrogenated Castor Oil Hypromellose Yellow Ferric Oxide Magnesium Stearate Microcrystalline Cellulose Povidone Silica, Colloidal Hydrated Mannitol 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 25°C. Store in the original package. 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_ _2_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _3_ _2_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Boxes of 30 tablets in blister strips. Each pack contains 3 blister strips of 10 tablets in an over-labelled cardboard outer carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND Preberite celoten dokument