Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
PERINDOPRIL TERT, BUTYLAMINE SALT, INDAPAMIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C09BA04
PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg INDAPAMIDE 1.25 mg
TABLET
PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg INDAPAMIDE 1.25 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Withdrawn
2005-10-10
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE USER COVERSYL PLUS 4MG/1.25MG TABLETS perindopril tert-butylamine/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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What COVERSYL PLUS 4mg/1.25mg is and what it is used for 2. Before you take COVERSYL PLUS 4mg/1.25mg 3. How to take COVERSYL PLUS 4mg/1.25mg 4. Possible side effects 5. How to store COVERSYL PLUS 4mg/1.25mg 6. Further information 1. WHAT COVERSYL PLUS IS AND WHAT IT IS USED FOR WHAT IS COVERSYL PLUS 4MG/1.25MG ? COVERSYL PLUS 4mg/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 PLUS 4MG/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 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. BEFORE YOU TAKE COVERSYL PLUS 4MG/1.25MG DO NOT TAKE COVERSYL PLUS 4MG/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 COVERSYL PLUS 4mg/1.25mg, - if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with Læs hele dokumentet
PAGE 1 OF 19 _ _ SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 19 1. NAME OF THE MEDICINAL PRODUCT COVERSYL PLUS 4mg/1.25mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 3.338 mg perindopril corresponding to 4 mg perindopril tert-butylamine and 1.25 mg indapamide. Excipient: 61.55 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, rod-shaped tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension, COVERSYL PLUS 4mg/1.25mg 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 PLUS 4mg/1.25mg 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 4mg/1.25mg tablet should be used when blood pressure is not adequately controlled on PRETERAX 2mg/0.625mg tablet (where available).When clinically appropriate, direct change from monotherapy to COVERSYL PLUS 4mg/1.25mg 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 ml/min, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium. _Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2) _ In severe hepatic impairment, treatment is contraindicated. In patients with moderate hepatic impairment, no dose modification is required. PAGE 3 OF 19 Children and adolescents COVERSYL PLUS 4m Læs hele dokumentet