Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MESALAZINE
DCH AURIGA (MALAYSIA) SDN. BHD.
MESALAZINE
35sachet Sachets; 100sachet Sachets
LOSAN PHARMA GMBH
SALOFALK ® GASTRO-RESISTANT PROLONGED-RELEASE GRANULES MESALAZINE 500MG / 1000MG / 1.5G / 3G 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Salofalk granules are used for 2. How Salofalk granules work 3. Before you use Salofalk granules 4. How to use Salofalk granules 5. While you are using them 6. Side effects 7. Storage and Disposal of Salofalk granules 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SALOFALK GRANULES ARE USED FOR Salofalk 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. HOW SALOFALK GRANULES WORK Salofalk granules contain the active substance mesalazine, an anti- inflammatory agent used to treat inflammatory bowel disease. BEFORE YOU USE SALOFALK GRANULES - _When you must not use them _ - if you are or have been told you are allergic (hypersensitive) to mesalazine, salicylic acid, salicylates such as Aspirin or any of the other ingredients of this medicine. - if you have a serious liver and/or kidney disease. _Pregnancy and breast-feeding: _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine You should only use Salofalk granules during pregnancy if your doctor tells you to. You should only use Salofalk granules during breast-feeding if your doctor tells you to, as this medicine may pass into breast milk. _ _ - _Before you start use them _ Before you start taking this medicine, you should tell your doctor - 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 your KIDNEY. - if you have ever developed a severe skin rash or skin peeling Perskaitykite visą dokumentą
spcpalmy-sagall-en4-aug21 1 PACKAGE INSERT 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 Mesalazine 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. WARNING Unsuitable for phenylketonurics 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 the elderly _ _ _For the treatment of acute episodes of ulcerative colitis _ Once daily, 1 sachet of Salofalk 3g granules, 1-2 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 spcpalmy-sagall-en4-aug21 2 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 3 times daily or 1 sachet of Salofalk 1000mg granules 3 times daily), if this is more convenient to the patien Perskaitykite visą dokumentą