País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Perindopril arginine
TAD Pharma GmbH
C09AA04
Perindopril arginine
10 milligram(s)
Tablet
perindopril
Marketed
2021-11-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PERINDOPRIL ARGININE TAD 5 MG TABLETS PERINDOPRIL ARGININE TAD 10 MG 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 TAD is and what it is used for 2. What you need to know before you take Perindopril Arginine TAD 3. How to take Perindopril Arginine TAD 4. Possible side effects 5. How to store Perindopril Arginine TAD 6. Contents of the pack and other information 1. WHAT PERINDOPRIL ARGININE TAD IS AND WHAT IT IS USED FOR Perindopril Arginine TAD 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 TAD 5 mg and 10 mg tablets are 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. Perindopril Arginine TAD 5 mg tablets are also used: - to treat heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL ARGININE TAD DO NOT TAKE PERINDOPRIL ARGININE TAD - if you are allergic to peridnopril, any other ACE inhibitor or any of the other ingredients of this medicine (list Llegiu el document complet
Health Products Regulatory Authority 06 December 2021 CRN00CPXC Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Perindopril Arginine TAD 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg perindopril arginine, equivalent to 6.790 mg of perindopril. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White or almost white, round, biconvex tablets marked with V2 on one side of the tablet. Diameter: approximately 8 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: Treatment of hypertension in adults. Stable coronary artery disease: Reduction of risk of cardiac events in adult 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 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 one month of treatment. 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 discontinued 2 to 3 days before beginning therapy with perindopril (see section 4.4). In hypertensive patients in w Llegiu el document complet