Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Sanofi Industries South Africa (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS HYDROCHLOROTHIAZIDE 12,5 mg IRBESARTAN 300,0 mg
Registered
2003-01-03
1 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S3 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: APROVEL 75 MG (Tablets) APROVEL 150 MG (Tablets) APROVEL 300 MG (Tablets) The active ingredient is irbesartan. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING APROVEL. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. APROVEL 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. WHAT APROVEL CONTAINS: The active substance in APROVEL tablets is irbesartan. Each tablet contains 75 mg, 150 mg or 300 mg irbesartan. The other inactive ingredients are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide and a film-coating. WHAT APROVEL IS USED FOR: APROVEL belongs to a group of medicines known as angiotensin II receptor blockers (ARB's). APROVEL is used in the treatment of high blood pressure (hypertension) and for the protection of the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired renal function. BEFORE YOU TAKE APROVEL: 2 DO NOT TAKE APROVEL: if you are hypersensitive (allergic) to irbesartan or any of the other ingredients of APROVEL (see “WHAT APROVEL CONTAINS”) if you have a history of angioedema (swelling around your face, throat or tongue) related to previous therapy with ARBs or to angiotensin converting enzyme inhibitors (ACEIs): You must never again be given these medicines if you have hereditary angioedema (swelling around your face, throat or tongue) if you have heart disease characterised by obstruction of blood flow and thickening of heart tissue (hypertrophic obstructive cardiomyopathy) if you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis) or a transplanted kidney If you have kidney problems and are taking flu Прочитать полный документ
1 SCHEDULING STATUS: S3 PROPRIETARY NAME AND DOSAGE FORM: APROVEL ® 75 MG tablets APROVEL ® 150 MG tablets APROVEL ® 300 MG tablets COMPOSITION: APROVEL tablets contain 75 mg, 150 mg or 300 mg of irbesartan. The other ingredients are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide and a film-coating. Contains lactose monohydrate. PHARMACOLOGICAL CLASSIFICATION: A 7.1.3 Other hypotensives PHARMACOLOGICAL ACTION: PHARMACODYNAMIC PROPERTIES: MECHANISM OF ACTION: Irbesartan is a specific antagonist of angiotensin II receptors (AT 1 subtype), known as an angiotensin receptor blocker (ARB). Angiotensin II is an important component of the renin- angiotensin system (RAS) and is involved in the pathophysiology of hypertension and in sodium homeostasis. Irbesartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selective antagonism of the angiotensin II (AT 1 subtype) receptors localised on vascular smooth muscle cells and in the adrenal cortex. It has no agonist activity at the AT 1 receptor and a much greater affinity (more than 8500-fold) for 2 the AT 1 receptor than for the AT 2 receptor (a receptor that has not been shown to be associated with cardiovascular homeostasis). Irbesartan does not inhibit enzymes involved in the renin-angiotensin system (i.e. renin, angiotensin converting enzyme [ACE]), or affect other hormone receptors or ion channels involved in the cardiovascular regulation of blood pressure and sodium homeostasis. Irbesartan blockade of AT 1 receptors interrupts the feedback loop within the renin-angiotensin system, resulting in increases in plasma renin levels and angiotensin II levels. Aldosterone plasma concentrations decline following irbesartan administration. However, serum potassium levels are not significantly affected (mean increase of < 0,1 mmol/l) at the recommended doses. Irbesartan has no notable effects on serum triglycerides, cholesterol or glucose concentrations. There is no ef Прочитать полный документ