Maa: Malesia
Kieli: englanti
Lähde: 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 4MG FILM-COATED TABLETS Perindopril tert-butylamine 4mg WHAT IS IN THIS LEAFLET 1. What COVERSYL 4mg is and what it is used for 2. How COVERSYL 4mg works 3. Before you use COVERSYL 4mg 4. How to use COVERSYL 4mg 5. While you are using COVERSYL 4mg 6. Side effects 7. Storage and Disposal of COVERSYL 4mg 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT COVERSYL 4MG IS AND WHAT IT IS USED FOR Coversyl is an angiotensin converting enzyme (ACE) inhibitor. Coversyl is used: - to treat _ _ arterial hypertension, - to treat heart failure (when the heart is unable to pump enough blood to meet the body’s needs), - 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 an operation to improve the blood supply to the heart by widening the vessels that supply it. HOW COVERSYL 4MG 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. BEFORE YOU USE COVERSYL 4MG - _When you must not use it _ DO NOT TAKE COVERSYL 4MG - if you are allergic (hypersensitive) to perindopril or any of the other ingredients of this medicine (listed in Section 8), 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 in early pregnancy – see pregnancy section). - if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. - if you are hav Lue koko asiakirja
_Final PI_Kotra_Coversyl 4mg_17.05.2022 _ _ _ _1 _ COVERSYL 4MG PERINDOPRIL 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 4 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Perindopril tert-butylamine. One tablet contains 3.338 mg perindopril corresponding to 4 mg perindopril tert-butylamine. Excipient with known effect: lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Light-green, rod-shaped tablet, engraved with on one face and scored on both edges. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of hypertension Heart failure Treatment of symptomatic heart failure 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 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. _ _ 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 _Final PI_Kotra_Coversyl 4mg_17.05.2022 _ _ _ _2 _ 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 once daily after one month of treatment. Symptomatic hypotension may occur following initiation o Lue koko asiakirja