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Public Summary Summary for ARTG Entry: 56651 WL-CAPTOPRIL 12.5 captopril 12.5mg tablet bottle ARTG entry for Medicine Registered Sponsor Biotech Pharmaceuticals Pty Ltd Postal Address 83 Cherry Lane,LAVERTON NORTH, VIC, 3026 Australia ARTG Start Date 19/02/1997 Product category Medicine Status Active Approval area Drug Safety Evaluation Branch Conditions Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995. Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995. Products 1. WL-CAPTOPRIL 12.5 captopril 12.5mg tablet bottle Product Type Effective date Single Medicine Product 3/07/2002 Warnings See Product Information and Consumer Medicine Information for this product Specific Indications Hypertension: Treatment of hypertension. In using WL-Captopril, consideration should be given to the risk of neutropenia/agranulocytosis. WL-Captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive. Myocardial infarction: To improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction, manifested as an ejection fraction less than or equal to 40% and to reduce the incidence of overt heart failure and subsequent hospitalisations for congestive heart failure in these patients. The efficacy data for the use of captopril following myocardial infarction are strongest for initiation of therapy beyond three days post-infarction. Heart Failure: Treatment of heart failure. In symptomatic patients it is recommended that WL-Captopril be administered together with a diuretic. Diabetic Nephropathy: Treatment of diabetic nephropathy in patients with type 1 insulin dependent diabetes mellitus. Additional Product information Container information Type Material Life Time Temperature Closure Conditions Bottle Not recorded 2 Years Store below 30 degrees Celsius Not recorded Protect from Moisture Pack Size/Poison information Pack Size Poison Schedule 90 tablets (S4) Prescription Only Medicine Components 1. Medicine Component Dosage Form Tablet, uncoated Route of Administration Oral Visual Identification white 3.2 x 6.35mm, oval flat bevelled edge tablet - debossed "355", score line and "12.5" on one side and a stylised "R" logo on the other. Active Ingredients Captopril 12.5 mg © Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm. Page 1 of 1 Produced at 17.06.2017 at 09:56:15 AEST This is not an ARTG Certificate document. The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown. Visit www.tga.gov.au for contact information Public Summary Standard Indications