Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PERINDOPRIL ARGININE; INDAPAMIDE
SERVIER MALAYSIA SDN BHD
PERINDOPRIL ARGININE; INDAPAMIDE
30Tablet Tablets; 10Tablet Tablets
LES LABS SERVIER INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 COVERSYL PLUS 5MG/1.25MG FILM-COATED TABLETS _Perindopril arginine 5mg / Indapamide 1.25mg _ WHAT IS IN THIS LEAFLET 1. What COVERSYL PLUS 5mg/1.25mg is and what it is used for 2. How COVERSYL PLUS 5mg/1.25mg works 3. Before you use COVERSYL PLUS 5mg/1.25mg 4. How to use COVERSYL PLUS 5mg/1.25mg 5. While you are using COVERSYL PLUS 5mg/1.25mg 6. Side effects of COVERSYL PLUS 5mg/1.25mg 7. Storage and Disposal of COVERSYL PLUS 5mg/1.25mg 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT COVERSYL 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. HOW COVERSYL PLUS 5MG/1.25MG WORKS 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. BEFORE YOU USE COVERSYL PLUS 5MG/1.25MG - _When you must not use it _ 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 sulfonamides or any of the other ingredients this medicine (listed in section 8), - if you have experienced symptoms such as wheezing, swelling of the face, lips or tongue with difficulty in swallowing or breathing, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema), - if you have diabetes or impaired kidney function and y Lue koko asiakirja
Final PI_Cov Plus 5mg_08.08.2022 1 USED IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected this drug should be discontinued as soon as possible. 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 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. Final PI_Cov Plus 5mg_08.08.2022 2 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, Lue koko asiakirja