Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE
DCH AURIGA (MALAYSIA) SDN. BHD.
5-AMINO SALICYLIC ACID(5-ASA),MESALAZINE
100Tablet Tablets
LOSAN PHARMA GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SALOFALK ® GASTRO-RESISTANT TABLETS Mesalazine 250 mg / 500 mg 1 WHAT IS IN THIS LEAFLET 1. What Salofalk tablets are used for 2. How Salofalk tablets work 3. Before you use Salofalk tablets 4. How to use Salofalk tablets 5. While you are using it 6. Side effects 7. Storage and Disposal of Salofalk tablets 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SALOFALK TABLETS ARE USED FOR Salofalk tablets are used for - the treatment of acute episodes and prevention of further episodes of an inflammatory disease of the large intestine (colon and rectum) known by doctors as ulcerative colitis. - the treatment of acute episodes of Crohn’s disease (an inflammatory bowel disease). HOW SALOFALK TABLETS WORK Salofalk tablets contain the active substance mesalazine, an anti- inflammatory agent used to treat inflammatory bowel disease. BEFORE YOU USE SALOFALK TABLETS - _When you must not use it _ - if you are or have been told you are allergic (hypersensitive) to salicylic acid, to salicylates such as Aspirin or to any of the other ingredients of Salofalk tablets (these are listed in section “Product description”). - if you have a serious liver and/or kidney disease. _Pregnancy and lactation _ 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 tablets during pregnancy if your doctor tells you to. You should also only use Salofalk tablets during breastfeeding if your doctor tells you to, as this medicine may pass into breast milk. - _Before you start to use it _ 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 HYPERSENSITIVITY to mesalazine, to salicylates (e.g. sulphasalazine) or any other ingredients of Salofalk tablets (these are Olvassa el a teljes dokumentumot
1 NAME OF MEDICINAL PRODUCT Salofalk ® 500mg gastro-resistant tablets Mesalazine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 500 mg mesalazine. Excipients with known effect: sodium carbonate and croscarmellose sodium\ For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Appearance: butter-yellow to ochre enteried-coated oblong formed tablets, lustreless with smooth surface, no cracking perceptible. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications – For the treatment of acute episodes and the maintenance of remission of ulcerative colitis. – For the treatment of acute episodes of Crohn’s disease. 4.2 Posology and method of administration Posology Adults and elderly Depending upon the clinical requirements in individual cases, the follow\ ing daily doses are recommended: Crohn’s disease Ulcerative colitis Acute episode Acute episode Prevention of recurrence/ long-term treatment Mesalazine (active substance) 1.5 g – 4.5 g 1.5 g – 3.0 g 1.5 g Salofalk ® 500mg tablets 3 x 1 to 3 x 3 3 x 1 to 3 x 2 3 x 1 Children: 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 determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day. The total dose should not exceed the maximum adult dose. Maintenance treatment (ulcerative colitis): To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should no\ t exceed the recommended adult dose. It is generally recommended that half the adult dose may be given to chi\ ldren up to a body weight of 40 kg; and the normal adult dose to those above 40 k\ g. Method of administration Salofalk 500mg tablets should be taken in the morning, at midday and in the evening, 1 hour before meals. They should be swallowed whole, not chewed\ , and taken with plenty of uid. Treatment with Salofalk 500mg tablets should be administered regularly and consistently, both in the Olvassa el a teljes dokumentumot