Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SULPHASALAZINE
PFIZER (MALAYSIA) SDN. BHD.
SULPHASALAZINE
100Tablet Tablets
Recipharm Uppsala AB
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SALAZOPYRIN EN ® TABLETS Sulfasalazine (500 mg) WHAT IS IN THIS LEAFLET 1. What SALAZOPYRIN EN is used for 2. How SALAZOPYRIN EN works 3. Before you use SALAZOPYRIN EN 4. How to use SALAZOPYRIN EN 5. While you are using it 6. Side Effects 7. Storage and Disposal of SALAZOPYRIN EN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT SALAZOPYRIN EN IS USED FOR SALAZOPYRIN EN tablets are used to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis (a painful joint disease). The main forms of inflammatory bowel disease are ulcerative colitis and Crohn’s disease. Ulcerative colitis is an inflammatory disease which affects only the large bowel (colon and back passage). Crohn’s disease is an inflammatory disease which may affect any part of the digestive system from the mouth to the anus, but it most commonly affects the last part of the small bowel and the first part of the large bowel. HOW SALAZOPYRIN EN WORKS The active substance in SALAZOPYRIN EN is sulfasalazine. It has a number of effects in the body. It is an immunosuppressive (suppresses overactivity of the immune system) and an anti-inflammatory medicine. BEFORE YOU USE SALAZOPYRIN EN - _When you must not use it _ Do not take SALAZOPYRIN EN if you - are allergic (hypersensitive) to sulfasalazine or any of the ingredients of SALAZOPYRIN EN tablets; - are allergic (hypersensitive) to salicylates (e.g. aspirin) or sulfonamides (e.g. a certain type of antibiotic); - have a disease known as porphyria (a rare blood pigment disorder). _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 for advice before taking this medicine. Your doctor will discuss the possible risks and benefits of taking SALAZOPYRIN EN during pregnancy and breast-feeding. SALAZOPYRIN EN are found in low levels in breast milk. Caution should be used, particularly if breastfe Baca dokumen lengkap
Pfizer confidential 2 PFIZER SALAZOPYRIN EN ® sulfasalazine 1. NAME OF THE MEDICINAL PRODUCT Salazopyrin EN ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: sulfasalazine. Each coated gastro -resistant tablet for oral administration contains 500 mg of sulfasalazine. 3. PHARMACEUTICAL FORM Salazopyrin EN coated tablet is a yellow -orange, elliptical, convex, enteric -coated tablet with the letter KPh on one face, and the product code “102” on the other. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Ulcerative colitis In the treatment of mild to moderate ulcerative co litis and as adjunctive therapy in severe ulcerative colitis. For maintenance of remission in ulcerative colitis. Crohn`s Disease In the treatment of active Crohn`s disease especially in patients with colonic involvement. Rheumatoid arthritis 4.2 Posology and Method of Administration The dosage should be adjusted according to the patient’s response to treatment and tolerance to the drug. The tablets should be taken at regular intervals during the day, preferably in connection with meals. Patients not previously treated with Salazopyrin EN tabs are recommended to increase the dose gradually during the first few weeks. The use of enteric coated tablets will reduce the incidence of gastrointestinal side effects. The enteric coated tablets should not be crushed or broken. Inflammatory bowel diseases Adults Acute attacks and severe attacks: 2- 4 tablets 3 -4 times a day may be given in conjunction with steroids as part of an intensive management regime. Moderate and mild attacks: 2 tablets 3 -4 times a day. Baca dokumen lengkap