Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
CAPTOPRIL
Clonmel Healthcare Ltd
C09AA01
CAPTOPRIL
12.5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
1996-06-10
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER ACEOMEL 12.5MG TABLETS ACEOMEL 25MG TABLETS ACEOMEL 50MG TABLETS CAPTOPRIL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BEACAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Aceomel Tablets are and what they are used for 2. What you need to know before you take Aceomel Tablets 3. How to take Aceomel Tablets 4. Possible side effects 5. How to store Aceomel Tablets 6. Contents of the pack and other information 1. WHAT ACEOMEL TABLETS ARE AND WHAT THEY ARE USED FOR The name of this medicine is Aceomel Tablets. Each tablet contains captopril (12.5mg, 25mg or 50mg) as the active ingredient. Aceomel Tablets belong to the group of medicines called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors work by helping to widen your blood vessels, which then make it easier for your heart to pump blood through them. Aceomel Tablets are used to treat high blood pressure and certain heart conditions. High blood pressure can lead to an increased risk of heart disease or stroke. Aceomel Tablets work by lowering your blood pressure which reduces this risk. Aceomel Tablets can also help people whose heart no longer pumps blood as well as it once did. This condition is known as Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aceomel 12.5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 12.5 mg captopril Excipients: Lactose monohydrate 32.5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. White, round, flat tablet scored on both sides. The tablets can be divided into equal halves. Diameter 6mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION: THE MANAGEMENT OF HYPERTENSION. HEART FAILURE: Captopril is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and when appropriate, digitalis and beta-blockers. MYOCARDIAL INFARCTION: - _Short-term (4 weeks) treatment: _Capropril is indicated in any clinically stable patients within the first 24 hours of an infarction. - _Long term prevention of symptomatic heart failure: _Captopril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction 40%). TYPE I DIABETIC NEPHROPATHY Captopril is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes. (See section 5.1, Pharmacodynamic properties). In patients on doses of over 100 mg daily plus or minus a diuretic, in those with severe renal impairment or those with severe congestive heart failure, use of captopril should be under specialist supervision. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 19/01/2015_ _CRN 2150823_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dose should be individualised according to patient’s profile (see section 4.4, special warnings and precautions for use) and blood pressur Lees het volledige document