Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
PERINDOPRIL ARGININE, INDAPAMIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C09BA04
PERINDOPRIL ARGININE 5 mg INDAPAMIDE 1.25 mg
FILM-COATED TABLET
PERINDOPRIL ARGININE 5 mg INDAPAMIDE 1.25 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2010-02-16
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COVERSYL 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 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 Plus 5mg/1.25mg is and what it is used for 2. What you need to know before you take Coversyl Plus 5mg/1.25mg 3. How to take Coversyl Plus 5mg/1.25mg 4. Possible side effects 5. How to store Coversyl Plus 5mg/1.25mg 6. Contents of the pack and other information 1. WHATCOVERSYL PLUS 5MG/1.25MG IS AND WHAT IT IS USED FOR Coversyl 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 PLUS 5MG/1.25MG DO NOT TAKE COVERSYL 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 ingredients of this medicine (listed in section 6), - if you have e Citiți documentul complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Coversyl 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 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 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 Plus 5mg/1.25mg film-coated tablet should be used when blood pressure is not adequately controlled on Preterax Arginine 2.5mg/0.625mg film-coated tablet (where available).When clinically appropriate, direct change from monotherapy to Coversyl 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 sections 4.3, 4.4 and 5.2) _ In severe hepatic impairment, treatment is contraindicated. In patients with mode Citiți documentul complet