Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE
Imbat Limited
PERINDOPRIL ARGININE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER COVERSYL ® ARGININE 5MG FILM-COATED TABLETS (perindopril arginine) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE 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, pharmacist or nurse. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Your medicine is available using the above name, but will be referred to as ‘Coversyl Arginine’ throughout this leaflet. WHAT IS IN THIS LEAFLET: 1. What Coversyl Arginine is and what it is used for 2. What you need to know before you take Coversyl Arginine 3. How to take Coversyl Arginine 4. Possible side effects 5. How to store Coversyl Arginine 6. Content of the pack and other information 1. WHAT COVERSYL ARGININE IS AND WHAT IT IS USED FOR Coversyl Arginine is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Coversyl Arginine is used: to treat _HIGH BLOOD PRESSURE_ (hypertension), to treat _HEART FAILURE_ (a condition where the heart is unable to pump enough blood to meet the body’s needs), to reduce the risk of cardiac events, such as heart attack, in patients with _STABLE CORONARY ARTERY DISEASE_ (a condition where the blood supply to the heart is red Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains perindopril 3.395 mg corresponding to 5 mg perindopril arginine. Excipients: lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Greece, Poland, Hungary and Czech Republic:_ _Poland and Greece_ Light-green, rod-shaped film-coated tablet engraved with the Servier logo on one face and plain on ther other. _Hungary and Czech Republic:_ Light-green, rod-shaped film-coated tablet engraved with the servier logo on one face and plain on the other, scored on both edges. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Treatment of hypertension. Heart failure: Treatment of symptomatic heart failure. Stable coronary artery disease: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response. - Hypertension: Coversyl Arginine may be used in monotherapy or in combination with other classes of antihypertensive therapy. The recommended starting dose is 5 mg given once daily in the morning. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. A starting dose of 2.5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. The dose may be increased to Read the complete document