국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
MESALAZINE
PCO Manufacturing
A07EC02
MESALAZINE
2 Grams
Granules Prolonged Release
Oral use
1 x 60 sachets
Product subject to prescription which may be renewed (B)
Ferring GmbH
Intestinal anti-inflammatory agents, aminosalicylic acid and similar agents
mesalazine
It is indicated for mild to moderate ulcerative colitis
Authorised
2015-04-17
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER PENTASA ® SACHET 2G PROLONGED RELEASE GRANULES Mesalazine 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, 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 you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What PENTASA Sachet is and what it is used for 2. What you need to know before you take PENTASA Sachet 3. How to take PENTASA Sachet 4. Possible side effects 5. How to store PENTASA Sachet 6. Contents of the pack and other information 1. WHAT PENTASA SACHET IS AND WHAT IT IS USED FOR PENTASA Sachet is used for the treatment of mild to moderate attacks of ulcerative colitis and to help maintain freedom from further attacks. Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine becomes inflamed and develops many tiny breaks in its surface (ulcers) which may bleed. PENTASA Sachet contains granules that slowly release the active ingredient (mesalazine). This helps reduce the inflammation and the painful symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PENTASA SACHET Do not take PENTASA Sachet if you are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (see Section 6) if you are allergic to other salicylates e.g. acetylsalicylic acid if you have severe liver and/or kidney problems WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Pentasa Sachet: if you are allergic to sulphasalazine (risk of allergy to salicylates) if you currently have or have previously had liver or kidney disease if you have a medical condition that can make you prone to bleeding 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pentasa Sachet 2 g prolonged release granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains mesalazine 2 g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release granules _Product imported from Greece:_ White-grey to pale white-brown granules. 4 CLINICAL PARTICULARS As per PA1009/006/006 5 PHARMACOLOGICAL PROPERTIES As per PA1009/006/006 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Ethylcellulose Povidone 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 package of the product on the market in the country of origin. The granules should be used immediately after first opening of the sachet. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Aluminium foil single dose container. Pack sizes: 1 x 60 sachets 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_ _4_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _9_ _8_ _7_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Any unused product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Unit 10 Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMB 전체 문서 읽기