Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOXAZOSIN MESILATE
Pfizer Healthcare Ireland
8 Milligram
Tablet Prolonged Release
2011-03-11
License Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Farmadura XL 8mg Prolonged -release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8mg doxazosin (as mesilate). For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged -Release Tablet. Farmadura XL 8mg prolonged - release tablets are white round, biconvex shaped tablets with an orifice on one side, marked ‘CXL8’. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Farmadura XL is indicated for the treatment of hypertension and can be used as a sole agent to control blood pressure in hypertensive patients. In patients inadequately controlled on single antihypertensive therapy, Farmadura 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 Farmadura 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 is 8mg once daily. Farmadura XL can be taken with or without food. The tablets shou Read the complete document