País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PERINDOPRIL,TERT-BUTYLAMINE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
PERINDOPRIL,TERT-BUTYLAMINE
30Tablet Tablets
LEK PHARMACEUTICALS D.D.
PERINDOSYL (Perindopril tert-butylamine 4 mg) ________________________________________________________________________________________________________ _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET: 1. What is PERINDOSYL used for 2. How PERINDOSYL works 3. Before you take PERINDOSYL 4. How to take PERINDOSYL 5. While you are using PERINDOSYL 6. Side effects 7. Storage and disposal of PERINDOSYL 8. Product description 9. Manufacturer & Product Registration Holder 10. Date of revision WHAT IS PERINDOSYL USED FOR PERINDOSYL is used to treat: • high blood pressure (hypertension) • heart failure (a condition where 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 PERINDOSYL 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 PERINDOSYL - _When you must not use it _ • if you are allergic (hypersensitive) to Perindopril or any of the other ingredients in the tablet or any other ACE inhibitor; • if you have had symptoms such as wheezing, swelling of the face, tongue or throat, intense itching, skin rashes, fainting or dizziness with previous ACE inhibitor treatment or have had these symptoms in any other circumstances (this condition is called angioedema); • if you have hereditary tendency to tissue swelling of unknown origin (hereditary or idiopathic angioedema); • if you are pregnant; • if you are taking aliskiren and have Type 2 diabetes; • if you are taking concomitant medicine (sacubitril/valsartan); • if you are having extracorporeal treatments; • if you have significant kidney artery na Llegiu el document complet
1. NAME OF THE MEDICINAL PRODUCT Perindosyl 4 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg perindopril tert-butylamine, equivalent to 3.338 mg perindopril. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 4 mg: white, round, biconvex tablet scored on one side and debossed with 4 on the reverse side. 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 It is recommended that Perindopril tert-butylamine is taken once daily in the morning before a meal with sufficient amount of fluid (e.g., water). The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response. Hypertension Perindopril tert-butylamine 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 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. After one month of treatment, the daily dose may be increased to 8 mg once daily. Symptomatic hypotension may occur following initiation of therapy with Perindopril tert-butylamine; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. If possible, the diuretic should be disc Llegiu el document complet