Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Mesalazine
PCO Manufacturing Ltd.
A07EC; A07EC02
Mesalazine
Prolonged-release granules
Aminosalicylic acid and similar agents; mesalazine
2023-05-05
PACKAGE LEAFLET: INFORMATION FOR THE USER PENTASA ® SACHET 4 G 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. See section 4. 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 Preberite celoten dokument
Health Products Regulatory Authority 08 May 2023 CRN00DGKW Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pentasa Sachet 4 g prolonged-release granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 4 g mesalazine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release granules _Product imported from Spain:_ White-grey to pale white-brown granules. 4 CLINICAL PARTICULARS As per PA1009/006/008 5 PHARMACOLOGICAL PROPERTIES As per PA1009/006/008 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 shall be the date shown on the sachet 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 sachet Pack sizes: 1 x 30 sachets 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Health Products Regulatory Authority 08 May 2023 CRN00DGKW Page 2 of 2 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/450/004 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 th May 2023 10 DATE OF REVISION OF THE TEXT Preberite celoten dokument