Šalis: Vokietija
kalba: vokiečių
Šaltinis: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
Mesalazin
Dr. Falk Pharma GmbH (3076297)
A07EC02
mesalazine
magensaftresistentes Retardgranulat
Mesalazin (21958) 500 Milligramm
zum Einnehmen
verlängert
2001-10-16
paleu-sag500-en11-jan21.docx 1/6 PACKAGE LEAFLET: INFORMATION FOR THE USER SALOFALK 500MG GASTRO-RESISTANT 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 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 500mg granules are and what they are used for 2. What you need to know before you take Salofalk 500mg granules 3. How to take Salofalk 500mg granules 4. Possible side effects 5. How to store Salofalk 500mg granules 6. Contents of the pack and other information 1. WHAT SALOFALK 500MG GRANULES ARE AND WHAT THEY ARE USED FOR Salofalk granules contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease. Salofalk 500mg granules are used for - the treatment of acute episodes and prevention of further episodes (recurrence) of an inflammatory disease of the large intestine (colon), known by doctors as ulcerative colitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALOFALK 500MG GRANULES DO NOT TAKE SALOFALK GRANULES - if you are allergic to mesalazine, salicylic acid, to salicylates such as Aspirin ® or any of the other ingredients of this medicine (listed in section 6). - if you have a serious liver or kidney disease. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Salofalk 500mg granules - 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 proble Perskaitykite visą dokumentą
spceu-sagall-en13-jan21.docx 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Salofalk 500mg gastro-resistant prolonged-release granules Salofalk 1000mg gastro-resistant prolonged-release granules Salofalk 1.5g gastro-resistant prolonged-release granules Salofalk 3g gastro-resistant prolonged-release granules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Salofalk 500mg granules contains 500 mg mesalazine. Each sachet of Salofalk 1000mg granules contains 1000 mg mesalazine. Each sachet of Salofalk 1.5g granules contains 1.5 g mesalazine. Each sachet of Salofalk 3g granules contains 3 g mesalazine. Excipients with known effect: Each sachet of Salofalk 500mg granules contains 1.0 mg aspartame and 0.02 mg sucrose. Each sachet of Salofalk 1000mg granules contains 2.0 mg aspartame and 0.04 mg sucrose. Each sachet of Salofalk 1.5g granules contains 3.0 mg aspartame and 0.06 mg sucrose. Each sachet of Salofalk 3g granules contains 6.0 mg aspartame and 0.12 mg sucrose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant prolonged-release granules Description: stick-formed or round, greyish white granules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of acute episodes and the maintenance of remission of ulcerative colitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults and elderly _ _For the treatment of acute episodes of ulcerative colitis _ Once daily 1 sachet of Salofalk 3g granules, 1 or 2 sachets of Salofalk 1.5g granules, 3 sachets of Salofalk 1000mg granules or 3 sachets of Salofalk 500mg granules (equivalent to 1.5 – 3.0 g mesalazine daily) preferably to be taken in the morning according to the individual clinical requirement. It is also possible to take the prescribed daily dose in three divided doses (1 sachet of Salofalk 500mg granules three times daily, or 1 sachet of Salofalk 1000mg granules three times daily), if this is more convenient to the patient. _For the maintenance of remission of ulcerative Perskaitykite visą dokumentą