Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE
G & A Licensing Limited
PERINDOPRIL ARGININE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-04-29
PACKAGE LEAFLET: INFORMATION FOR THE USER COVERSYL ® ARGININE 5MG FILM-COATED TABLETS PERINDOPRIL ARGININE IN THIS LEAFLET: 1. What COVERSYL ARGININE is and what it is used for 2. Before you take COVERSYL ARGININE 3. How to take COVERSYL ARGININE 4. Possible side effects 5. How to store COVERSYL ARGININE 6. Further 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 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. BEFORE YOU TAKE COVERSYL ARGININE DO NOT TAKE COVERSYL ARGININE • If you are allergic (hypersensitive) to perindopril, to any other ACE inhibitor or to any of the other ingredients of COVERSYL ARGININE, • If you are more than 3 months pregnant. (It is also better to avoid COVERSYL ARGININE in early pregnancy – see pregnancy section.) • 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 angio Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine 5 mg Film-coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Perindopril 3.395 mg corresponding to Perindopril arginine 5 mg Also includes lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet _Product imported from UK:_ Light-green, rod-shaped film-coated tablet engraved with "Company Logo" on one face and scored on both edges. The tablets can be divided into equal halves. 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 It is recommended that COVERSYL ARGININE 5 mg film-coated tablet is taken once daily in the morning before a meal. The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response. Hypertension: COVERSYL ARGININE 5 mg 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 10 mg once daily after one month of treatment. Symptomatic hypot Διαβάστε το πλήρες έγγραφο