Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Mesalazine
PCO Manufacturing Ltd.
A07EC; A07EC02
Mesalazine
1200 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; mesalazine
Authorised
2012-06-28
_ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER MEZAVANT ® XL 1200 MG GASTRO-RESISTANT, PROLONGED RELEASE TABLETS 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 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 any 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 Mezavant XL is and what it is used for 2. What you need to know before you take Mezavant XL 3. How to take Mezavant XL 4. Possible side effects 5. How to store Mezavant XL 6. Contents of the pack and other information 1. WHAT MEZAVANT XL IS AND WHAT IT IS USED FOR Pharmacotherapeutic group: Aminosalicylic acid and similar agents. Mezavant XL gastro-resistant, prolonged release tablets contain the active substance mesalazine, which is an anti-inflammatory drug for the treatment of ulcerative colitis. Ulcerative colitis is a disease of the colon (large bowel) and rectum (back passage), where the lining of the gut becomes red and swollen (inflamed) resulting in symptoms of frequent and bloody stools together with stomach cramps. When given for an acute episode of ulcerative colitis, Mezavant XL acts through the entire colon and rectum to treat the inflammation and reduce symptoms. The tablets can also be taken to help prevent recurrence of ulcerative colitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEZAVANT XL DO NOT TAKE MEZAVANT XL − If you are allergic (hypersensitive) to a family of drugs known as salicylates (which include aspirin) − If you are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (listed in section 6 of this leaflet) − If you have severe kidney Baca dokumen lengkapnya
Health Products Regulatory Authority 21 May 2019 CRN00902D Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mezavant XL 1200 mg gastro-resistant, prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1200mg mesalazine. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant, prolonged release tablets. _Product imported from Italy and The Netherlands:_ Red-brown, ellipsoidal, film-coated tablet, debossed on one side with 'S476'. 4 CLINICAL PARTICULARS As per PA1575/004/001 5 PHARMACOLOGICAL PROPERTIES As per PA1575/004/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet Core: Carmellose sodium Carnauba Wax Stearic Acid Silica, Colloidal Hydrated Sodium Starch Glycolate (Type A) Talc Magnesium Stearate Film-Coating: Methacrylic Acid-Methyl Methacrylate Copolymer (1:1) Methacrylic Acid-Methyl Methac1ylate Copolymer (l:2) Triethylcitrate Titanium Dioxide (E1 71) Red Ferric Oxide (E 172) Macrogol 6000 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product as marketed in the country of origin. Health Products Regulatory Authority 21 May 2019 CRN00902D Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 25 °C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Outer cardboard carton containing blister strips Pack size: 60 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/289/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 th June 2012 10 DATE OF REVISION OF THE TEXT May 2019 Baca dokumen lengkapnya