국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Perindopril tert-butylamine
KRKA, d.d., Novo mesto
C09AA; C09AA04
Perindopril tert-butylamine
2 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; perindopril
Marketed
2010-08-06
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL KRKA 2 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 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 Krka is and what it is used for 2. What you need to know before you take Perindopril Krka 3. How to take Perindopril Krka 4. Possible side effects 5. How to store Perindopril Krka 6. Contents of the pack and other information 1. WHAT PERINDOPRIL KRKA IS AND WHAT IT IS USED FOR The active substance of Perindopril Krka tablets belongs to the group of medicines called angiotensin converting enzyme (ACE) inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Perindopril Krka tablets are used: - TO TREAT HIGH BLOOD PRESSURE (HYPERTENSION), - TO TREAT SYMPTOMATIC 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL KRKA DO NOT TAKE PERINDOPRIL KRKA - if you are allergic to perindopril, any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6); - if you have had in the past a hypersensitivity reaction with sudden swelling of 전체 문서 읽기
Health Products Regulatory Authority 07 April 2022 CRN00CLLC Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril Krka 2 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg perindopril tert-butylamine, equivalent to 1.669 mg perindopril. Excipient(s) with known effect: Each tablet contains 30.2 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Tablets are white to almost white, round (diameter 7 mm), slightly biconvex tablets with bevelled 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: Perindopril 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. After one month of treatment, the daily dose may be increased to 8 mg once daily. Symptomatic hypotension may occur following initiation of therapy with perindopril; 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 전체 문서 읽기