Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
MESALAZINE
ESPL Regulatory Consulting Ltd
A07EC02
MESALAZINE
MODIFIED-RELEASE TABLET
MESALAZINE 1600 milligram(s)
POM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
Authorised
2018-11-22
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER MESALAZINE ESPL 1600 MG MODIFIED-RELEASE TABLETS mesalazine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Mesalazine ESPL is and what it is used for 2. What you need to know before you use Mesalazine ESPL 3. How to use Mesalazine ESPL 4. Possible side effects 5. How to store Mesalazine ESPL 6. Contents of the pack and other information 1. WHAT MESALAZINE ESPL IS AND WHAT IT IS USED FOR Mesalazine ESPL contains the active substance mesalazine. It is an anti-inflammatory medicine used for the treatment of ulcerative colitis. Ulcerative colitis is a disease in which the lining of the large intestine (colon) or the back passage (rectum) becomes inflamed (red and swollen). This may lead to frequent and bloody stools, often with abdominal cramps. Mesalazine ESPL treats and prevents inflammation throughout the entire colon and rectum (mild to moderate acute ulcerative colitis and for the prevention of relapse). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MESALAZINE ESPL DO NOT USE MESALAZINE ESPL: - if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to salicylates (e.g. acetylsalicylic acid) - if you have severe liver problems - if you have severe kidney problems WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Mesalazine ESPL if you have any medical conditions or illnesses, particularly if you have: - any lung disease problems, e.g. asthma. - impaired f Leggi il documento completo
Page 1 of 10 1. NAME OF THE MEDICINAL PRODUCT Mesalazine ESPL 1600 mg modified-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release tablet contains: 1600 mg mesalazine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified-release tablet. Film-coated, red/brown oblong tablets dimension of 23 x 11 x 9 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Ulcerative colitis. _ For the treatment of mild to moderate acute disease. For the maintenance of remission. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults, including the elderly (>65 years) The dose should be adjusted according to the severity of the disease and tolerance. _Acute disease_ : In the event of exacerbation, the dose can be increased to 4800 mg daily, once daily or in 2-3 divided doses. Once clinical remission is achieved, the dose should gradually be decreased to maintenance dose. Continued therapy should be carefully considered in subjects not responding by week 8. _Maintenance treatment_ : 1600 mg once daily. _ _ Other oral mesalazine formulations are available if an alternative dose for maintenance treatment is considered more appropriate. _ _ _ _ Elderly population _ _ No studies have been carried out in older people. Page 2 of 10 Paediatric population The safety and efficacy of Mesalazine ESPL in children and adolescents aged younger than 18 years of age has not been established. Method of administration: oral. The tablets must be swallowed whole with a glass of water. They must not be chewed, crushed or broken before swallowing. The tablets can be taken with or without food. If one or more doses have been missed, the next dose is to be taken as usual. 4.3 CONTRAINDICATIONS • Hypersensitivity to salicylates (including mesalazine) or any of the excipients listed in section 6.1. • Severe liver impairment. • Severe renal impairment (GFR < 30 mL/min/1.73 m 2 ). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Blood tests (differential blood count; liver function parameters such Leggi il documento completo