Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE; INDAPAMIDE
B & S Healthcare
C09BA04
PERINDOPRIL ARGININE; INDAPAMIDE
5/1.25 Milligram
Film-coated tablet
Product subject to prescription which may be renewed (B)
perindopril and diuretics
Authorised
2009-11-06
PACKAGE LEAFLET : INFORMATION FOR THE USER COVERSYL ® ARGININE PLUS 5MG/1.25MG FILM-COATED TABLETS (perindopril arginine/indapamide) 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. The name of your medicine is Coversyl Arginine Plus 5mg/1.25mg film-coated tablets but will be referred to as Coversyl Arginine Plus throughout this leaflet. IN THIS LEAFLET 1. What Coversyl Arginine Plus is and what it is used for 2. Before you take Coversyl Arginine Plus 3. How to take Coversyl Arginine Plus 4. Possible side effects 5. How to store Coversyl Arginine Plus 6. Further information 1. WHAT COVERSYL ARGINIE PLUS IS AND WHAT IT IS USED FOR WHAT IS COVERSYL ARGININE PLUS? Coversyl Arginine Plus 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 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 in 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 Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Coversyl Arginine Plus 5mg/1.25mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3.395mg perindopril corresponding to 5mg perindopril arginine and 1.25mg indapamide. Excipients: Contains lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from the UK and Poland:_ White, rod-shaped film-coated tablet 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 Oral route 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 Lire le document complet