국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Equity Pharmaceutical (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS MESALAZINE 800,0 mg
Registered
2006-01-12
PATIENT INFORMATION LEAFLET SCHEDULING STATUS S3 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM ASACOL TABLETS, MESALAZINE (5-AMINOSALICYLIC ACID), 400 mg (tablets) ASACOL 800, MESALAZINE (5-AMINOSALICYLIC ACID), 800 mg (tablets) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ASACOL TABLETS Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or your pharmacist. ASACOL has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. 1. WHAT ASACOL TABLETS CONTAINS The active substance is mesalazine (also known as 5-aminosalicylic acid). ASACOL TABLETS: each tablet contains Mesalazine (5-aminosalicylic acid) 400 mg. ASACOL 800 Tablets: each tablet contains Mesalazine (5-aminosalicylic acid) 800 mg. The other ingredients are: lactose monohydrate (the 400 mg and 800 mg tablets contain 76,4 mg and 152,8 mg of lactose monohydrate respectively), magnesium stearate (vegetable origin), povidone, sodium starch glycolate (Type A) and talc. Film-coating contains: Macrogol 6000, methacrylic acid-methylmethacrylatecopolymer, talc, triethyl citrate and iron oxides (yellow pigment and red pigment) Contains sugar (lactose monohydrate). 2. WHAT ASACOL TABLETS IS USED FOR ASACOL contains mesalazine. This is an anti-inflammatory medicine used to treat ulcerative colitis. 3. BEFORE YOU TAKE ASACOL TABLETS DO NOT TAKE ASACOL TABLETS: If you are allergic (hypersensitive) to mesalazine or any of the other ingredients of ASACOL tablets If you are allergic (hypersensitive) to salicylates (e.g. aspirin) If you tend to bleed easily or for a longer time than normal If you have an ulcer in your stomach or in the first part of the small bowel (duodenum) If you have severe kidney problems If you have severe liver problems TAKE SPECIAL CARE WITH ASACOL TABLETS: Please tell your doctor if you have any medical conditions or illnesses, 전체 문서 읽기
PROFESSIONAL INFORMATION SCHEDULING STATUS S3 PROPRIETARY NAME AND DOSAGE FORM ASACOL TABLETS ASACOL 800 Tablets COMPOSITION Per ASACOL TABLETS (400 mg tablet): Mesalazine (5-aminosalicylic acid) 400 mg Per ASACOL 800 mg tablet: Mesalazine (5-aminosalicylic acid) 800 mg _Excipients_: The 400 mg and 800 mg tablets contain 76,4 mg and 152,8 mg of lactose monohydrate respectively. Other excipients are magnesium stearate, povidone, sodium starch glycolate (Type A) and talc. Film-coating contains: Macrogol 6000, methacrylic acid-methylmethacrylatecopolymer, talc, triethyl citrate, red pigment (ferric oxide) and yellow pigment (ferric oxide). Contains sugar (lactose monohydrate). PHARMACOLOGICAL CLASSIFICATION A 11.10 Medicines acting on gastrointestinal tract, other. PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES The acrylic based resin coating, which is pH-dependent (pH=7), delays the release of mesalazine (5- aminosalicylic acid) until the tablet reaches the distal ileum and colon. There it acts locally, probably involving the inhibition of prostaglandin and leukotriene synthesis. PHARMACOKINETIC PROPERTIES Mesalazine is mostly excreted in the faeces either as 5-aminosalicylic acid (5-ASA) or N-acetyl-5-ASA. About 20 per cent of the 5-ASA released in the colon is absorbed and rapidly acetylated to N-acetyl-5-ASA which is excreted in the urine. The acetylated metabolite (active ingredient) has a half-life of approximately 10 hours and that of the parent compound approximately one hour. INDICATIONS _Ulcerative Colitis_: ASACOL is used for the treatment and maintenance of remission in ulcerative colitis. CONTRAINDICATIONS Hypersensitivity to mesalazine or to any of the other ingredients of ASACOL tablets Sensitivity to salicylates Severe renal impairment (GFR less than 30 mℓ per minute) Severe liver impairment Gastric and duodenal ulcers Bleeding tendency WARNINGS AND SPECIAL PRECAUTIONS Blood tests (differential blood count, liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip 전체 문서 읽기