Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Mesalazine
Imbat Limited
A07EC; A07EC02
Mesalazine
800 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; mesalazine
Authorised
2016-07-01
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ASACOLON ® 800MG GASTRO-RESISTANT TABLETS (mesalazine) Your medicine is imported from the UK under the name of ‘Octasa’ but is marketed as ‘Asacolon’ in Ireland. Your medicine is available using the above name but will be referred to as Asacolon throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, please 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Asacolon is and what it is used for 2. What you need to know before you take Asacolon 3. How to take Asacolon 4. Possible side effects 5. How to store Asacolon 6. Contents of the pack and other information 1. WHAT ASACOLON IS AND WHAT IT IS USED FOR The name of your medicine is Asacolon 400mg Gastro-resistant Tablets. The tablets are called gastro- resistant tablets because they are covered with a coating which allows the tablets to pass through the stomach without dissolving. The tablet coating will break down in the bowel where the active mesalazine is released. Asacolon Gastro-resistant Tablets contain the active substance mesalazine. This is an anti-inflammatory medicine used to treat ulcerative colitis and to prevent further episodes of Crohn’s disease. Ulcerative colitis is a disease in which the lining of the large bowel (colon) or back passage (rectum) becomes inflamed (red and swollen). Asacolon acts locally at the inflamed sites to reduce the inflammation. It can also be used to prevent further attacks of ulcerative colitis. Crohn’s disease is a disease in which the lining of the small a Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asacolon 800mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains: 800mg mesalazine Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. _Product imported from the UK_ The tablets are reddish to brownish and oblong-shaped. 4 CLINICAL PARTICULARS As per PA2018/001/002 5 PHARMACOLOGICAL PROPERTIES As per PA2018/001/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate Sodium starch glycolate (Type A) Magnesium stearate (vegetable origin) (E572) Talc (E553b) Povidone (E1201) Methacrylic acid-methyl methacrylate copolymer (1:2) Triethyl citrate Iron oxides (E172) Macrogol 6000 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as marketed 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_ _ _ _2_ _0_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _1_ _9_ _6_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer containing blister strips. Pack size: 90 gastro-resistant tablets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED M Olvassa el a teljes dokumentumot