国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Mesalazine
Lexon (UK) Ltd
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
2017-05-19
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: What Asacolon is and what it is used for What you need to know before you take Asacolon How to take Asacolon Possible side effects How to store Asacolon Contents of the pack and other information WHAT ASACOLON IS AND WHAT IT IS USED FOR The name of your medicine is Asacolon 800 mg 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 and large bowel is affected and becomes inflamed. If you have been treated by surgery for Crohn’s disease and it is under control, Asacolon act to prevent further episodes of Crohn’s disease. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASACOLON DO NOT TAKE ASACOLON * If you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 完全なドキュメントを読む
Health Products Regulatory Authority 11 March 2020 CRN009MZW Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asacolon 800 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains: Mesalazine 800 mg. Excipient with known effect: lactose, _see section 4.4_. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant Tablet. _Product imported from the United Kingdom_ 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) Triethyl citrate Talc E553b Methacrylic acide - methylmethacrylate copolymer (1:2) Povidone E1201 Magnesium stearate (vegetable origin) Iron oxides E172 Macrogol 6000 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. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. Store in the original package in order to protect from moisture. Health Products Regulatory Authority 11 March 2020 CRN009MZW Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips contained within an outer cardboard carton, containing 90 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon (UK) Ltd Unit 18, Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1097/008/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 th May 2017 10 DATE OF REVISION OF THE TEXT March 2020 完全なドキュメントを読む