Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESILATE
ANTAH PHARMA SDN. BHD.
AMLODIPINE BESILATE
30Tablet Tablets
Drogsan Ilaclari San.ve Tic.A.S
PATIENT INFORMATION LEAFLET AMLOVAS 5 MG TABLET/AMLODIPINE BESILATE AMLOVAS 10 MG TABLET/AMLODIPINE BESILATE WHAT IS IN THIS LEAFLET What AMLOVAS is used for How AMLOVAS works Before you use AMLOVAS How to take AMLOVAS While you are using AMLOVAS Side effects After using AMLOVAS Product description Manufacturer Marketing authorization holder WHAT AMLOVAS IS USED FOR AMLOVAS belongs to a group of medicines called calcium antagonists. AMLOVAS is used to treat: - high blood pressure - chest pain due to narrowing of the blood vessels of the heart muscle (angina pectoris) or the more rare form of chest pain caused by cramping of the blood vessels of the heart muscle . HOW AMLOVAS WORKS If you suffer from high blood pressure, AMLOVAS works by relaxing blood vessels, so that blood passes through them more easily. If you suffer from angina, AMLOVAS works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. AMLOVAS does not provide immediate relief of chest pain from angina. BEFORE YOU USE AMLOVAS YOU MUST NOT TAKE AMLOVAS, if you - are allergic to amlodipine or similar calcium channel blockers (the so-called dihydropyridine derivates like felodipine, nifedipine, nimodipine) or to any of the other ingredients (for a full list of ingredients, see _Product description_ ). - are suffering from cardiogenic shock. This is a condition where the heart is unable to pump sufficient blood around the body. The symptoms of cardiogenic shock are low blood pressure, low pulse and fast heartbeat. - are suffering from narrowing of the aorta (aortic stenosis). - suffer from chest pain at rest or with minimal effort (unstable angina pectoris). - are pregnant or breast-feeding. - have severe low blood pressure. BEFORE YOU START TO TAKE AMLOVAS, tell your doctor if you - have heart failure or have suffered a heart attack during the past month. - have liver problems - are giving this medicine to a child under 18 years of age - are elderly, your doctor may monitor you closely. T Read the complete document
PRESENTATION Tab 10 mg x 30’s DESCRIPTION Each round white tablet contains 13,889 mg of Amlodipine besylate equivalent to 10 mg Amlodipine base and as excipients microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate and magnesium stearate. PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties Amlodipine is a calcium ion influx inhibitor (slow channel or calcium antagonist) and inhibits the transmembrane influx of calcium ion into the cardiac and vascular smooth muscle. The mechanism of the hypertensive action of amlodipine is due to a direct relaxant effect on the vascular smooth muscle. The precise mechanism by which amlodipine relieves angina has not been fully determined, but amlodipine reduces to the total ischemic burden by the following 2 actions: 1. Amlodipine dilates the peripheral arteriols and thus, reduces the total peripheral resistance (afterload) against which the heart works. Since the heart rate remains stable, this unloading of the heart reduces myocardial energy consumption and oxygen requirements. 2. The mechanism of action of amlodipine probably involves dilation of the main coronary arteries and coronary arteriols, both normal and ischemic regions. This dilatation increases myocardial oxygen delivery in patients with coronary artery spasm (Prinzental’s or variant angina) and blunts smoking-induced coronary vasoconstriction. In patients with hypertension, once-daily dosing provides clinically significant reductions of blood pressure in both the supine and standing positions throughout the 24-hr interval. Due to the slow onset of action, acute hypotension is not a feature of amlodipine administration. In patients with angina, once-daily administration of amlodipine increases total exercise time, time to angina onset, and time to 1 mm ST segment depression and decreases both angina attack frequency and nitroglycerine tablet consumption. Amlodipine has not been associated with any adverse metabolic effects or changes in plasma lipids and is suitable for use Read the complete document