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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
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