国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Perindopril arginine; Indapamide
Les Laboratoires Servier
C09BA; C09BA04
Perindopril arginine; Indapamide
5/1.25
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and diuretics; perindopril and diuretics
Marketed
2007-05-11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COVERSYL ARGININE PLUS 5MG/1.25MG FILM-COATED TABLETS perindopril arginine/indapamide 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 of the 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 Coversyl Arginine Plus 5mg/1.25mg is and what it is used for 2. What you need to know 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. Contents of the pack and other information 1. WHAT COVERSYL ARGININE PLUS 5MG/1.25MG IS AND WHAT IT IS USED FOR 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) in adults. 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COVERSYL ARGININE PLUS 5MG/1.25MG DO NOT TAKE COVERSYL ARGININE PLUS 5MG/1.25MG - if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides or any of the other 完全なドキュメントを読む
Health Products Regulatory Authority 12 July 2022 CRN00CNLG Page 1 of 19 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 with known effect: 71.33 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, rod shaped film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults, Coversyl Arginine Plus5mg/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. Special populations _Elderly (see section 4.4)_ Treatment should be initiated after considering blood pressure response and renal function. _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 dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium. _Hepatic impairment (see 完全なドキュメントを読む