Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE INDAPAMIDE
LTT Pharma Limited
PERINDOPRIL ARGININE INDAPAMIDE
5/1.25 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
COVERSYL ARGININE PLUS 5MG / 1.25 MG FILM-COATED TABLETS (perindopril arginine / indapamide) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE * 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: What Coversyl Arginine Plus 5mg/1.25mg is and what it is used for Before you take Coversyl Arginine Plus 5mg/1.25mg How to take Coversyl Arginine Plus 5mg/1.25mg Possible side effects How to store Coversyl Arginine Plus 5mg/1.25mg Further information WHAT COVERSYL ARGININE PLUS 5MG/1.25MG IS AND WHAT IT IS USED FOR WHAT IS COVERSYL ARGININE PLUS 5MG/1.25MG? Coversyl Arginine Plus 5mg/1.25mg is a combination of two active ingredients, perindopril and indapamide. It is an anti-hypertensive and is used in the treatment of high blood pressure (hypertension). WHAT IS COVERSYL ARGININE PLUS 5MG/1.25MG USED FOR? Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure. BEFORE YOU TAKE COVERSYL ARGININE PLUS 5MG/1.25MG DO NOT Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine Plus 5mg/1.25mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine and 1.25 mg indapamide. Excipient: lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablets _Product imported from Hungary & UK:_ White, rod-shaped film-coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension, COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ One COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet per day as a single dose, preferably to be taken in the morning, and before a meal. When possible individual dose titration with the components is recommended. COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet should be used when blood pressure is not adequately controlled on COVERSYL ARGININE PLUS 2.5mg/0.625mg film-coated tablet (where available).When clinically appropriate, direct change from monotherapy to COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet may be considered. _Elderly (see section 4.4)_ Treatment should be initiated after considering blood pressure response and renal function. _Patients with renal impairment (see section 4.4)_ In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contraindicated. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination. In patients with creatinine clearance greater than or equal to 60 ml/min, no Read the complete document