Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
mesalazine, Quantity: 800 mg
Chiesi Australia Pty Ltd
Mesalazine
Tablet, enteric coated
Excipient Ingredients: lactose monohydrate; sodium starch glycollate type A; magnesium stearate; purified talc; povidone; methacrylic acid copolymer; triethyl citrate; iron oxide yellow; iron oxide red; macrogol 6000
Oral
30, 180, 90, 60
(S4) Prescription Only Medicine
For the treatment of mild to moderate ulcerative colitis and maintenance of remission in adults.
Visual Identification: Coated, reddish to brownish oblong tablets with a glossy to matt finish; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-09-21
ASACOL CMI v7.0 ASACOL ® _Mesalazine _ _400 mg, 800 mg and 1600 mg _ _Enteric Coated Tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ASACOL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ASACOL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ASACOL IS USED FOR This medicine is used to treat and prevent further episodes of ulcerative colitis. ASACOL contains the active ingredient mesalazine. This is an anti-inflammatory agent used to treat ulcerative colitis. Ulcerative colitis is a disease of the large bowel (colon) or back passage (rectum), in which the lining of the bowel becomes inflamed (red and swollen). ASACOL acts locally at the site of inflammation (colon, rectum and terminal ileum) to reduce this inflammation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. ASACOL is not addictive. It is available only with a doctor`s prescription. ASACOL is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE ASACOL _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ASACOL IF: • you are allergic to mesalazine or any of the other ingredients of this medicine listed at the end of this leaflet. • Patients who are intolerant to lactose should note that ASACOL 400 mg and 800 mg tablets contain a small amount of lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine • you are allergic to salicylates (e.g. Aspirin) • you have severe liver problems • you have severe kidney problems. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED O read_full_document
ASACOL Product Information ASACOL PI v7.0 1 AUSTRALIAN PRODUCT INFORMATION - ASACOL ® (MESALAZINE) 1 NAME OF THE MEDICINE Mesalazine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ASACOL enteric coated tablets contain 400 mg, 800 mg or 1600 mg mesalazine as the active ingredient. Excipient with known effect: sugars as lactose (400 mg and 800 mg tablets). For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM _ASACOL 400 MG AND 800 MG TABLETS _ ASACOL enteric coated tablets are reddish to brownish oblong tablets with a glossy to matt finish (ASACOL 400 mg dimensions: 15 x 6 x 7 mm; ASACOL 800 mg dimensions: 17 x 8 x 8 mm). ASACOL consists of a tablet core which is coated with a copolymer providing the tablet a pH- dependent disintegration behaviour. Therefore ASACOL tablets resist the acidic environment of the stomach and small intestine, whereas disintegration and drug release occurs from pH 7 onwards to ensure start of drug delivery at the target site, i.e., from the terminal ileum onwards. _ASACOL 1600 MG TABLETS _ ASACOL enteric coated tablets are film coated dark orange oblong tablets with a glossy to matte finish (ASACOL 1600 mg dimensions: 23 x 11 x 9 mm). The ASACOL tablet contains a core of 1600 mg mesalazine covered by a multi-layer coating system. This system consists of a layer of methacrylic acid - methyl methacrylate copolymer (Eudragit S) combined with starch particles on top of a middle alkaline buffer layer (which accelerates drug release). The coating is designed to delay release of mesalazine until intestinal fluids reach a pH of 7. The starch can be digested by colonic bacteria which also provides a second trigger for release of mesalazine from the coated tablet. Systemic bioavailability/plasma concentrations of mesalazine therefore are of no relevance for therapeutic efficacy, but rather a criterion for safety. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASACOL is indicated for the treatment of mild to moderate ulcerative colitis and maintenance of remiss read_full_document