CARDURA XL 8 Milligram Tablet Prolonged Release
Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Toote omadused
(SPC)
20-04-2024
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Toimeaine:
DOXAZOSIN MESILATE
Saadav alates:
G & A Licensing Limited
INN (Rahvusvaheline Nimetus):
DOXAZOSIN MESILATE
Annus:
8 Milligram
Ravimvorm:
Tablet Prolonged Release
Retsepti tüüp:
Product subject to prescription which may be renewed (B)
Volitamisolek:
Withdrawn
Loa andmise kuupäev:
2013-04-29
Toote omadused
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardura XL 8mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8mg doxazosin (as mesilate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablets
_Product imported from UK_
Cardura XL 8mg Prolonged-release tablets are white, round, biconvex shaped tablets with an orifice in one side,
marked CXL8.
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 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 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
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