البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
PERINDOPRIL ARGININE, INDAPAMIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C09BA04
INDAPAMIDE 2.5 mg PERINDOPRIL ARGININE 10 mg
FILM-COATED TABLET
INDAPAMIDE 2.5 mg PERINDOPRIL ARGININE 10 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Authorised
2010-07-29
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COVERSYL PLUS 10MG/2.5MG 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 10mg/2.5mg is and what it is used for 2. What you need to know before you take Coversyl Plus 10mg/2.5mg 3. How to take Coversyl Plus 10mg/2.5mg 4. Possible side effects 5. How to store Coversyl Plus 10mg/2.5mg 6. Contents of the pack and other information 1. WHAT COVERSYL PLUS 10MG/2.5MG IS AND WHAT IT IS USED FOR Coversyl Plus 10mg/2.5mg 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). Coversyl Plus 10mg/2.5mg is prescribed for patients already receiving perindopril 10 mg and indapamide 2.5 mg from separate tablets, these patients may instead receive one tablet of Coversyl Plus 10mg/2.5mg which contains both ingredients. 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 10MG/2.5MG DO NOT TAKE اقرأ الوثيقة كاملة
Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Coversyl Plus 10mg/2.5mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 6.79 mg perindopril equivalent to 10 mg perindopril arginine and 2.5 mg indapamide. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round film-coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Coversyl Plus 10mg/2.5mg _ _ is indicated as substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril and indapamide given concurrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One Coversyl Plus 10mg/2.5mg _ _ tablet per day as a single dose, preferably to be taken in the morning, and before a meal. Special populations _Elderly (see section 4.4) _ In elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated if renal function is normal and after considering blood pressure response. _Renal impairment (see section 4.4) _ In severe and moderate renal impairment (creatinine clearance below 60 ml/min), treatment is contraindicated. 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. Page 2 of 24 In patients with moderate hepatic impairment, no dose modification is required. _Paediatric population _ The safety and efficacy of Coversyl Plus 10mg/2.5mg in children and adolescents have not yet been established. No data are available. Coversyl Plus 10mg/2.5mg _ _ should not be used in children and adolescents. Method of administration Oral use. 4.3 CONTRAINDICATIONS _Linked to perindopril: _ - Hypersensitivity to the active substance or to any other ACE inhibitor - History of angioedema (Quincke’s oedema) associated with previo اقرأ الوثيقة كاملة