Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Mesalazine
Dr. Falk Pharma GmbH
A07EC; A07EC02
Mesalazine
1000 milligram(s)
Prolonged-release granules
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; mesalazine
Marketed
2003-08-08
palieuk-sag1000-en8-jan23 PACKAGE LEAFLET: INFORMATION FOR THE USER SALOFALK 1000MG GASTRO-RESISTANT PROLONGED-RELEASE GRANULES Mesalazine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT IN- FORMATION 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 1000mg granules are and what they are used for 2. What you need to know before you take Salofalk 1000mg granules 3. How to take Salofalk 1000mg granules 4. Possible side effects 5. How to store Salofalk 1000mg granules 6. Contents of the pack and other information 1. WHAT SALOFALK 1000MG GRANULES ARE AND WHAT THEY ARE USED FOR Salofalk granules contain the active substance mesalazine, an anti-inflammatory agent used to treat in- flammatory bowel disease. Salofalk 1000mg 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 1000MG GRANULES DO NOT TAKE SALOFALK GRANULES - If you are allergic to mesalazine, salicylic acid, salicylates such as Aspirin or any of the other ingredi- ents 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 1000MG 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 Lestu allt skjalið
Health Products Regulatory Authority 01 March 2023 CRN00DDGY Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salofalk 1000mg prolonged-release granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of Salofalk 1000mg granules contains 1000 mg mesalazine. Excipients with known effect: Each sachet of Salofalk 1000mg granules contains 2.0 mg aspartame and 0.04 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 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 mild to moderate 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 colitis_ The standard treatment is 0.5 g mesalazine three times daily (in the morning, at midday and in the evening) corresponding to a total dose of 1.5 g mesalazine per day. For patients known to be at increased risk for relapse for medical reasons or due to difficulties to adhere to application of three daily doses the dosing schedule can be adapted to 3.0 g mesalazine given as a single daily dose preferably in the morning. _Paediatric population_ There is only limited documentation for an effect in children (age 6-18 years). _Children 6 years of age and older_ ACTIVE DISEASE: To be determi Lestu allt skjalið