Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Les Laboratoires Servier
PERINDOPRIL TERT-BUTYLAMINE SALT
8 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2014-07-11
27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ PERINDOPIL SERVIER 8 MG TABLETS 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 Perindopril Servier is and what it is used for 2. What you need to know before you take Perinopril Servier 3. How to take Perindopril Servier 4. Possible side effects 5. How to store Perindopril Servier 6. Content of the pack and other information 1. WHAT PERINDOPRIL SERVIER IS AND WHAT IT IS USED FOR Perindopril Servier 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 Servier 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 BEFO Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril Servier 8 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril Servier 8 mg Tablets: 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 White, round, convex tablets. 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 Perindopril Tablets may be used in monotherapy or in combination with other classes of antihypertensive therapy. 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 Perindopril Tablets; 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 di Přečtěte si celý dokument