Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
AstraZeneca Pharmaceuticals (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS CANDESARTAN CILEXETIL 32,0 mg HYDROCHLOROTHIAZIDE 12,5 mg
Registered
2013-06-09
1 FINAL PATIENT INFORMATION LEAFLET 2 PATIENT INFORMATION LEAFLET: ATACAND 8, 16 & 32 MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. SCHEDULING STATUS: S3 PROPRIETARY NAME (AND DOSAGE FORM): ATACAND® 8 MG, ATACAND® 16 MG, ATACAND® 32 MG (TABLET) The active substance is candesartan cilexetil. 1. WHAT ATACAND CONTAINS: The active substance in ATACAND 8 mg tablet is 8 mg candesartan cilexetil. The active substance in ATACAND 16 mg tablet is 16 mg candesartan cilexetil. The active substance in ATACAND 32 mg tablet is 32 mg candesartan cilexetil. The other ingredients are carmellose calcium, hyprolose, iron oxide, magnesium stearate, maize starch and macrogol. Contains sugar (lactose monohydrate). 3 2. WHAT ATACAND IS USED FOR: ATACAND is a type of medicine called an angiotensin II receptor antagonist, which by blocking the effects of the hormone angiotensin II causes the blood vessels to relax and widen. This results in a lowering of your blood pressure. ATACAND is used for treating high blood pressure (hypertension). It is also used for treating a heart condition known as heart failure where the heart does not pump the blood around the body as well as it should. 3. BEFORE YOU TAKE ATACAND: DO NOT TAKE ATACAND: If you are pregnant, think you might be pregnant or considering becoming pregnant. If you are breast-feeding. If you have a severe kidney problem. If you are allergic to any of the ingredients in ATACAND. If you have a severe liver problem. If you have a condition known as bilateral renal artery stenosis or stenosis in the presence of a single kidney. This is a narrowing of the kidney arteries supplying blood to the kidney/s, leading to a red Read the complete document
1 FINAL PACKAGE INSERT 2 SCHEDULING STATUS: S3 PROPRIETARY NAME (AND DOSAGE FORM): ATACAND® 8 MG, ATACAND® 16 MG, ATACAND® 32 MG (TABLET) COMPOSITION: Each ATACAND 8 mg tablet contains 8 mg candesartan cilexetil. Each ATACAND 16 mg tablet contains 16 mg candesartan cilexetil. Each ATACAND 32 mg tablet contains 32 mg candesartan cilexetil. Contains sugar (lactose monohydrate). PHARMACOLOGICAL CLASSIFICATION: A 7.1.3 Other hypotensives PHARMACOLOGICAL ACTION: _Pharmacodynamic properties: _ Candesartan cilexetil is a prodrug. After oral administration it is converted to the active drug, candesartan, by ester hydrolysis during absorption from the gastrointestinal tract. Candesartan is an angiotensin II receptor antagonist, selective for AT 1 receptors, with tight binding to and slow dissociation from the receptor. It has no agonist activity. The major physiological effects of angiotensin II, such as vasoconstriction, aldosterone stimulation, regulation of salt and water homeostasis and stimulation of cell growth, are mediated via the type 1 (AT 1 ) receptor. 3 The antagonism of the angiotensin II (AT 1 ) receptors results in dose related increases in plasma renin activity, angiotensin I and angiotensin II concentrations, and a decrease in plasma aldosterone concentration. _Hypertension:_ In hypertension ATACAND causes a dose-related sustained reduction in arterial blood pressure over the dosage interval. The antihypertensive action is due to decreased systemic peripheral resistance, while heart rate, stroke volume and cardiac output are not affected. After administration of a single dose of ATACAND, onset of antihypertensive effect generally begins within 2 hours. With continuous treatment, the maximum reduction in blood pressure is generally attained within 4 weeks and is sustained during long-term treatment. Candesartan has a peak to trough ratio of peak versus trough effects of close to 1. ATACAND increases renal blood flow and either has no effect on, or increases glomerular filtration rate while renal vascula Read the complete document