Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
DOXAZOSIN MESILATE
PCO Manufacturing
8 Base Milligrams
Tablet Prolonged Release
2003-10-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardura XL 8 mg Prolonged-release Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged- release tablet contains 8 mg doxazosin (as mesilate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. _Product imported from the Netherlands and the UK:_ White, round, biconvex shaped tablets with an orifice in one side, marked ‘CXL 8’ on one side, plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cardura XL is indicated for the treatment of hypertension and can be used as the sole agent to control blood pressure in hypertensive patients. In patients inadequately controlled on single antihypertensive therapy, Cardura XL may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The initial dose of Cardura XL is 4mg once daily. A significant number of patients will be controlled on this dose. If necessary, the dosage may be increased to 8mg once daily according to patient response. The maximum recommended dose of Cardura XL is 8mg once daily. Cardura XL can be taken with or without food. The tablets should be swallowed whole with a sufficient amount of liquid. They should not be cut or chewed. Elderly: In common with other drugs of this class, the dosage should be kept as low as possible and increments made under close supervision. Use in renally-impaired Patients : Since the pharmacokinetics of doxazosin are unchanged in patients with renal insufficiency, and there is no evidence that doxazosin aggravates existing renal dysfunction, the usual dosages may be used in these patients. Cardura XL is Preberite celoten dokument