Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PERINDOPRIL,TERT-BUTYLAMINE
SERVIER MALAYSIA SDN BHD
PERINDOPRIL,TERT-BUTYLAMINE
30Tablet Tablets
KOTRA PHARMA (M) SDN. BHD.
_ _ _Consumer Medication Information Leaflet (RIMUP) _ 1 COVERSYL 8MG FILM-COATED TABLET Perindopril tert-butylamine 8mg WHAT IS IN THIS LEAFLET: 1. What is COVERSYL 8MG used for 2. How COVERSYL 8MG works 3. Before you use COVERSYL 8MG 4. How to use COVERSYL 8MG 5. While you are using COVERSYL 8MG 6. Side effects 7. Storage and Disposal of COVERSYL 8MG 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT COVERSYL 8MG IS USED FOR COVERSYL 8MG is used: - to treat high blood pressure (hypertension), - to reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or bypass surgery or a procedure to dilate the coronary arteries. HOW COVERSYL 8MG WORKS COVERSYL 8MG is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for the heart to pump blood through them. BEFORE YOU USE COVERSYL 8MG - _When you must not use it _ DO NOT TAKE COVERSYL 8MG: - if you are allergic to perindopril or any of the other ingredients of this medicine (listed in section ‘Product description’), or to any other ACE inhibitor, - if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, 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 are more than 3 months pregnant (It is also better to avoid COVERSYL 8MG, tablet in early pregnancy – see Pregnancy and Breast-feeding sections), - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren, - if you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Coversyl may not be suitable for you, - if you have kidney problems where the bl Prečítajte si celý dokument
_Final PI_Coversyl 8mg_Kotra_17.05.2022 _ _ _ _ 1 _ COVERSYL® 8MG USE 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 8 MG, TABLET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril tert-butylamine...................................................................................................……6.676mg as perindopril tert-butylamine ..................................................................................................... 8.000mg For one tablet Excipient with known effect: lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Green, round, biconvex tablet, with a heart engraved on one face and the Servier logo on the other . 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION: Treatment of hypertension. STABLE CORONARY ARTERY DISEASE: Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response. _ _ Hypertension COVERSYL 8mg may be used in monotherapy or in combination with other classes of antihypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1). The recommended starting dose is 4 mg given once daily_ _in the morning. _ _ _Final PI_Coversyl 8mg_Kotra_17.05.2022 _ _ _ _ 2 _ Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. A starting dose of 2 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. The dose may be increased to 8 mg on Prečítajte si celý dokument