Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
SERVIER LABORATORIES SA (PTY) LTD
Tablet
Each tablet contains INDAPAMIDE 0,625 mg PERINDOPRIL ARGININE 2,5 mg
2014-06-03
Page 1 of 14 Approved PIL Applicant: Servier Laboratories SA (Pty) Ltd Product: Coversyl Plus Date: 9 April 2020 PATIENT INFORMATION LEAFLET COVERSYL PLUS TABLET perindopril tert-butylamine and indapamide Contains sugar (lactose) SCHEDULING STATUS: S3 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING COVERSYL PLUS. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. COVERSYL PLUS has been prescribed to you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What COVERSYL PLUS is and what it is used for 2. What you need to know before you take COVERSYL PLUS 3. How to take COVERSYL PLUS 4. Possible side effects 5. How to store COVERSYL PLUS 6. Contents of the pack and other information 1. WHAT COVERSYL PLUS IS AND WHAT IT IS USED FOR COVERSYL PLUS 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 Page 2 of 14 Approved PIL Applicant: Servier Laboratories SA (Pty) Ltd Product: Coversyl Plus Date: 9 April 2020 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. COVERSYL PLUS is used to treat high blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE TAKING COVERSYL PLUS DO NOT TAKE COVERSYL PLUS: if you are hypersensitive (allergic) to perindopril or any other ACE-inhibitor, or to indapamide or any other sulphonamides or any of the other Les hele dokumentet
Page 1 of 40 Approved PI Applicant: Servier Laboratories SA (Pty) Ltd Product: Coversyl Plus Date: 9 April 2020 COVERSYL ® PLUS SCHEDULING STATUS: S3 1. NAME OF MEDICINE COVERSYL ® PLUS, tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of perindopril tert-butylamine salt and 1,25 mg of indapamide. Excipient with known effect: 61,55 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White, 8-mm x 4-mm rod-shaped tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS COVERSYL ® PLUS is indicated for the treatment of essential hypertension, in patients where blood pressure is not adequately controlled and where fixed combination is considered more appropriate than monotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage regimen depends upon the individual requirements of the patient and is at the discretion of the medical doctor. One COVERSYL ® PLUS tablet per day as a single dose, preferably to be taken in the morning before a meal. Page 2 of 40 Approved PI Applicant: Servier Laboratories SA (Pty) Ltd Product: Coversyl Plus Date: 9 April 2020 Special populations ELDERLY (SEE SECTION 4.4): It is recommended to start the treatment with only one of the constituents. PATIENTS WITH RENAL FAILURE (SEE SECTION 4.4): In cases of severe renal failure (creatinine clearance below 30 ml/min), treatment is contra-indicated. In patients with a creatinine clearance greater than or equal to 30 ml/min and less than 60 ml/min, it is recommended to start the treatment with only one of the constituents. It is not necessary to change the dose when the creatinine clearance is greater than 60 ml/min. Method of administration Oral use. 4.3 CONTRAINDICATIONS This medicine is contraindicated in the following circumstances: Linked to indapamide: • Hypersensitivity to any of the ingredients of COVERSYL ® PLUS or any other ACE-inhibitor. • A history of angioedema related to previous therapy with ACE-inhibitors or angiotensin receptor bloc Les hele dokumentet