CARDURA XL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-03-2023
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Active ingredient:
DOXAZOSIN MESILATE
Available from:
PCO Manufacturing
Dosage:
8 Base Milligrams
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2003-10-17
Summary of Product characteristics
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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
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