Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Mesalazine
Dr. Falk Pharma GmbH
A07EC; A07EC02
Mesalazine
1 gram(s)
Suppository
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; mesalazine
Marketed
2010-06-18
PACKAGE LEAFLET: INFORMATION FOR THE USER SALOFALK 1G SUPPOSITORIES 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 Salofalk 1g Suppositories are and what they are used for 2. What you need to know before you use Salofalk 1g Suppositories 3. How to use Salofalk 1g Suppositories 4. Possible side effects 5. How to store Salofalk 1g Suppositories 6. Contents of the pack and other information 1. WHAT SALOFALK 1G SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Salofalk 1g Suppositories contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease. Salofalk 1g Suppositories are used for − the treatment of mild to moderate acute episodes of an inflammatory disease limited to the rectum (back passage) known by doctors as ulcerative colitis or ulcerative proctitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALOFALK 1G SUPPOSITORIES DO NOT USE SALOFALK 1G SUPPOSITORIES − If you are allergic to salicylic acid, to salicylates such as acetylsalicylic acid (e.g., Aspirin ® ) or the other ingredient of this medicine (listed in section 6). − If you have a serious liver or kidney disease. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE USING SALOFALK 1G SUPPOSITORIES − If you have a history of problems with your lungs, particularly if you suffer from BRONCHIAL ASTHMA . − If you have a history of allergy to sulphasalazine, a substance related to mesalazine. − If you suffer with problems of your LIVER . − If you suffer with problems of Přečtěte si celý dokument
Health Products Regulatory Authority 15 August 2023 CRN00DGJ5 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salofalk 1g Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 1 g mesalazine. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suppositories Appearance: light beige coloured, torpedo-shaped suppositories 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute mild to moderate ulcerative colitis that is limited to the rectum (ulcerative proctitis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults and older people_ One Salofalk 1g Suppository once daily (equivalent to 1 g mesalazine daily) inserted into the rectum. _Paediatric population_ There is little experience and only limited documentation for an effect in children. _Duration of treatment_ The treatment of acute episodes of ulcerative colitis usually lasts 8 weeks. The duration of use is determined by the physician. Method of administration For rectal administration only. Salofalk 1g Suppositories should be administered preferably at bedtime. Treatment with Salofalk 1g Suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved. 4.3 CONTRAINDICATIONS Salofalk 1g Suppositoriesare contraindicated in patients with: - known hypersensitivity to salicylates or to the excipient listed in section 6.1 - severe impairment of hepatic or renal function Health Products Regulatory Authority 15 August 2023 CRN00DGJ5 Page 2 of 7 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip-sticks) should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If the findings are normal, follow-up tests sh Přečtěte si celý dokument