국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE SALT
Les Laboratoires Servier
C09AA04
PERINDOPRIL TERT-BUTYLAMINE SALT
4 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
2000-12-20
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PRINDACE 4 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 of the side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Prindace is and what it is used for 2. What you need to know before you take Prindace 3. How to take Prindace 4. Possible side effects 5. How to store Prindace 6. Content of the pack and other information 1. WHAT PRINDACE IS AND WHAT IT IS USED FOR Prindace 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. Prindace 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRINDACE DO NOT TAKE PRINDACE - if you are allergic to perindopril, or any of the other ingredients in this medicine (listed in Section 6), to 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 sym 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prindace 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril tert-butylamine. One tablet contains 3.338 mg perindopril corresponding to 4 mg perindopril tert-butylamine. Excipient with known effect: lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, rod-shaped tablet, scored on both edges. The tablet 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 Posology The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response. Hypertension Prindace 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 Prindace; 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 Prindace (see section 4.4). In hypertensive patients in whom the diuretic cannot be 전체 문서 읽기