Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
PERINDOPRIL ARGININE INDAPAMIDE
IMED Healthcare Ltd.
PERINDOPRIL ARGININE INDAPAMIDE
5/1.25 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
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 onto others. It may harm them even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. - This medicinal product is authorised in Hungary as Coverex-AS Komb 5/1.25mg film tabletta. In this leaflet: 1. What COVERSYL ARGININE PLUS 5mg/1.25mg is and what it is used for 2. Before you take COVERSYL ARGININE PLUS 5mg/1.25mg 3. How to take COVERSYL ARGININE PLUS 5mg/1.25mg 4. Possible side effects 5. How to store COVERSYL ARGININE PLUS 5mg/1.25mg 6. Further Information 1. 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 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 Διαβάστε το πλήρες έγγραφο
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 3.395mg 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 & Hungary: 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 m Διαβάστε το πλήρες έγγραφο