Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DOXAZOSIN
IMED Healthcare Ltd.
4 Milligram
Tablet Prolonged Release
2008-06-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardura XL 4mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4mg doxazosin (as mesilate). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged Release Tablet. _Product imported from the UK:_ White, round, biconvex shaped tablets with an orifice on one side marked ‘CXL4’ and 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 a sole agent to control blood pressure inhypertensive patients. In patients inadequately controlled on single antihypertensive therapy, Cardura XL may be used in combination with athiazide 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. Ifnecessary, the dosage may be increased to 8mg once daily according to patient response. The maximum recommended dose 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 not dialysable. USE IN HEPATICALLY IMPAIRED PATIENTS: There are only limited d Prečítajte si celý dokument