Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Les Laboratoires Servier
C09AA09
PERINDOPRIL TERT-BUTYLAMINE SALT
8 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
2004-06-25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COVERSYL TABLETS 8 MG_ _ perindopril tert-butylamine 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 of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Coversyl is and what it is used for 2. What you need to know before you take Coversyl 3. How to take Coversyl 4. Possible side effects 5. How to store Coversyl 6. Content of the pack and other information 1. WHAT COVERSYL IS AND WHAT IT IS USED FOR Coversyl 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 is used: - to treat _HIGH BLOOD PRESSURE_ (hypertension), - 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 reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVERSYL DO NOT TAKE COVERSYL - if you are allergic to perindopril, or any of the other ingredients of this medicine (listed in Section 6), or any other ACE inhibitor - if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema). - if you are more than 3 months pregnant Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Tablets 8 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Coversyl Tablets 8 mg: Each tablet contains 8 mg perindopril tert-butylamine salt, equivalent to 6.676 mg perindopril Excipient with known effect: lactose. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablet Green, round, biconvex tablet, engraved with on one face and on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of hypertension 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 4.4 “Special warnings and special precautions for use”) and blood pressure response. - Hypertension Coversyl may be used in monotherapy or in combination with other classes of antihypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1). The recommended starting dose is 4 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 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. The dose may be increased to 8 mg once daily after one month of treatment. Symptomatic hypotension may occur following initiation of therapy with Coversyl; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with Coversyl (see section 4.4 “Special warnings and special precautions for use”). In hypertensive patients i Read the complete document