Cardura XL 8mg Prolonged-release tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

DOXAZOSIN MESILATE

Διαθέσιμο από:

Imbat Limited

Φαρμακολογική κατηγορία (ATC):

C02CA; C02CA04

INN (Διεθνής Όνομα):

DOXAZOSIN MESILATE

Δοσολογία:

8 milligram(s)

Φαρμακοτεχνική μορφή:

Prolonged-release tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Alpha-adrenoreceptor antagonists; doxazosin

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2007-05-11

Φύλλο οδηγιών χρήσης

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARDURA™ XL 8MG PROLONGED–RELEASE TABLETS
Doxazosin (as mesilate)
IMPORTANT THINGS THAT YOU SHOULD KNOW
ABOUT YOUR MEDICINE:

Cardura XL is a treatment for high blood pressure

This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

You should take Cardura XL regularly to get the maximum
benefit, even if you are feeling well.

Most people do not have serious problems when taking
Cardura XL but side effects can occur – see Section 4 for
details. If you experience swelling of the face, tongue or
windpipe, see your doctor immediately. If any of the side
effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Taking other medicines may sometimes cause problems.
Check with your doctor or pharmacist before taking this or
any other medicines.

If you are, or are trying to become, pregnant, do not take
Cardura XL and tell your doctor.
Please read the rest of this leaflet. It includes other important
information on the safe and effective use of this medicine that
might be especially important to you. If you have any further
questions, ask your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Cardura XL is and what it is used for
2.
Before you take Cardura XL
3.
How to take Cardura XL
4.
Possible side effects
5.
How to store Cardura XL
6.
Further information
1.
WHAT CARDURA XL IS AND WHAT IT IS USED FOR
Cardura XL is one of a group of medicines called alpha-blockers. It
is used to treat high blood pressure.
Cardura XL can be used to treat high blood pressure
(hypertension), by relaxing blood vessels so that blood passes
through them more easily. This helps to lower blood pressure.
2.
BEFORE YOU TAKE CARDURA XL
DO NOT TAKE CARDURA XL:

If you have had an allergic reaction in the past to Cardura
XL, the active ingredient doxazosin, other types of
quinazolines (such as prazosin or terazosin) or any of

Αρχείο Π.Χ.Π.

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 the UK;_
Cardura XL 8mg are white, round, biconvex shaped tablets with an
orifice on one side marked ‘CXL8’ 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 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 are only limited data in
patients with liver impairment and on the effects of
drugs known to influence hepatic metabolism (e.g. cimetidine). As with
any drug metabolised wholly by the liver,
Cardura XL should be used with care in patien