Cardura XL 4 mg Prolonged-release tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Doxazosin

Tilgjengelig fra:

Pfizer Healthcare Ireland

ATC-kode:

C02CA; C02CA04

INN (International Name):

Doxazosin

Dosering :

4 milligram(s)

Legemiddelform:

Prolonged-release tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Alpha-adrenoreceptor antagonists; doxazosin

Autorisasjon status:

Marketed

Autorisasjon dato:

1999-10-29

Informasjon til brukeren

mock up 8342
Package leaflet: Information for the patient
IRELAND
CARDURA
®
XL 4mg
CARDURA
®
XL 8mg
Prolonged–release Tablets
Doxazosin (as mesilate)
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness 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. If you
experience swelling of the face, tongue or windpipe, see your doctor
immediately. If you get any side
effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this
leaflet. See section 4.
•
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 or pharmacist.
What is in this leaflet
1.
What Cardura XL is and what it is used for
2.
What you need to know before you take Cardura XL
3.
How to take Cardura XL
4.
Possible side effects
5.
How to store Cardura XL
6.
Contents of the pack and other 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.
In patients with an enlarged prostate gland, CARDURA XL is taken to
treat poor and/or frequent passing of
urine. This is common in patients with an enlarged prostate gland.
CARDURA XL works by relaxing muscle
around the bladder exit

Preparatomtale

Health Products Regulatory Authority
07 April 2021
CRN00C2HQ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cardura XL 4 mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxazosin mesilate: 4.85 mg equivalent to 4mg doxazosin.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White, film-coated, round, biconvex shaped tablets with an orifice on
one side, marked CXL4.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_HYPERTENSION:_
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.
_ _
_BENIGN PROSTATIC HYPERPLASIA: _
Cardura XL is indicated for the treatment of urinary outflow
obstruction and symptoms associated with benign prostatic
hyperplasia (BPH).
Cardura XL may be used in BPH patients who are either hypertensive or
normotensive. While the blood pressure changes in
normotensive patients with BPH are not usually clinically significant,
patients with hypertension and BPH have had both
conditions effectively treated with doxazosin monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
_ELDERLY PATIENTS:_
In common with other drugs of this class, the dosage should be kept as
low as possible and increments made under close
supervision.
_PATIENTS WITH RENAL IMPAIRMENT:_
Since the pharmacokinetics of doxazosin are unchanged in patients with
renal insufficiency, and there is no evidence that
doxazosin aggravates existing renal dysfunc