Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Perindopril arginine
Clonmel Healthcare Ltd
C09AA04
Perindopril arginine
Film-coated tablet
perindopril
Not marketed
2024-03-15
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL ARGININE CLONMEL 2.5 MG FILM-COATED TABLETS PERINDOPRIL ARGININE CLONMEL 5 MG FILM-COATED TABLETS PERINDOPRIL ARGININE CLONMEL 10 MG 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 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 Perindopril Arginine Clonmel is and what it is used for 2. What you need to know before you take Perindopril Arginine Clonmel 3. How to take Perindopril Arginine Clonmel 4. Possible side effects 5. How to store Perindopril Arginine Clonmel 6. Contents of the pack and other information 1. WHAT PERINDOPRIL ARGININE CLONMEL IS AND WHAT IT IS USED FOR Perindopril Arginine Clonmel 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. Perindopril Arginine Clonmel 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) (only Perindopril Arginine Clonmel 2.5 mg and 5 mg). ‒ 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 PERINDOPRIL ARGININE CLONMEL DO NOT TAKE PERINDOPRIL ARGININE Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 20 March 2024 CRN00CV3V Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril Arginine Clonmel 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg perindopril arginine equivalent to 6.790 mg perindopril. Excipient with known effect Each film-coated tablet contains 232.75 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Green to marble green, rounded, biconvex film-coated tablet of diameter 9.0 ± 0.45 mm with one-sided debossing "10". 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 section 4.4) and blood pressure response. Hypertension Perindopril Arginine Clonmel 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 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 1 month of treatment. Symptomatic hypotension may occur following initiation of therapy with Perindopril Arginine Clonmel; 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 possi Lesen Sie das vollständige Dokument