Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL TERT-BUTYLAMINE
Arrow Generics Limited
C09AA04
PERINDOPRIL TERT-BUTYLAMINE
8 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
2008-05-23
1 RENEWAL AUG 2017 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL TERT-BUTYLAMINE 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 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, 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 tert-butylamine 8 mg tablets is and what it is used for 2. What you need to know before you take Perindopril tert-butylamine 8 mg tablets 3. How to take Perindopril tert-butylamine 8 mg tablets 4. Possible side effects 5. How to store Perindopril tert-butylamine 8 mg tablets 6. Contents of the pack and other information 1. WHAT PERINDOPRIL TERT-BUTYLAMINE 8 MG TABLETS IS AND WHAT IT IS USED FOR Perindopril tert-butylamine 8 mg tablets 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 tert-butylamine 8 mg tablets 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 BEFORE YOU TAKE PERINDOPRIL TERT-BUTYLAMINE 8 MG TABLETS DO NOT TAKE PERINDOPRIL TERT-BUTYLAMINE 8 MG TABLETS: - if you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to other ACE inhibitors - if you ar Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril tert-butylamine 8mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8mg of perindopril tert-butylamine equivalent to 6.676mg of perindopril Excipient with known effect: 140mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, capsule-shaped convex tablet, embossed with ‘PI’ bisect ‘8’ on one side and ‘>’ on the other side. The tablet can be divided into equal doses. 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 tert-butylamine 8 mg tablets 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 Perindopril tert-butylamine 8 mg 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 diuretic should be discontinued 2 to 3 days before beg Read the complete document