CARDURA 1 Milligram Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

DOXAZOSIN MESILATE

Disponível em:

Pfizer Limited

Código ATC:

C02CA04

DCI (Denominação Comum Internacional):

DOXAZOSIN MESILATE

Dosagem:

1 Milligram

Forma farmacêutica:

Tablets

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Alpha-adrenoreceptor antagonists

Status de autorização:

Authorised

Data de autorização:

1987-12-21

Folheto informativo - Bula

Page 1 of 6
Pfleet number:
2016-0022147
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARDURA
®
1MG TABLETS
CARDURA
®
2MG 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.

Cardura is a treatment for high blood pressure, or the symptoms caused
by enlargement of the prostate
gland in men.

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 regularly to get the maximum benefit, even if
you are feeling well.

Most people do not have serious problems when taking Cardura 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 and
tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What Cardura is and what it is used for
2.
What you need to know before you take Cardura
3.
How to take Cardura
4.
Possible side effects
5.
How to store Cardura
6.
Contents of the pack and other information
1.
WHAT CARDURA IS AND WHAT IT IS USED FOR
Cardura is one of a group of medicines called alpha-blockers.
It is used to treat high blood pressure, or
the symptoms caused by enlargement of the prostate gland in men.
Cardura is 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 is taken to treat
poor and/or

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CARDURA 1mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxazosin mesilate
1.213 mg equivalent to 1 mg doxazosin.
Excipient with known effect:
Each tablet contains 40 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White, round, biconvex tablets: marked “CN 1” on one side and
marked with the Pfizer logo on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_HYPERTENSION:_
Cardura 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 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 is indicated as an adjunct in the treatment of urinary outflow
obstruction and symptoms associated with benign
prostatic hyperplasia (BPH). It may therefore be of value in patients
awaiting prostatic surgery or for whom surgery is
not possible.
Cardura may be used in BPH patients who are either hypertensive or
normotensive.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS:_
Cardura is used in a once daily regimen and may be administered in the
morning or evening.
_HYPERTENSION:_
It is recommended that therapy be initiated at 1 mg given once daily
for one or two weeks to minimise the potential for
postural hypotension and/or syncope (see section 4.4).
The dosage may then be increased to 2 mg once daily for an
additional one or two weeks.
If necessary the daily dosage should then be increased gradually at
similar intervals to 4
mg, 8 mg, and l6 mg as determined by patient response to achieve the
desired reduction in blood pressure.
The usual
dose is 2-4 mg once daily.
The maximum daily dose should not exceed 16mg
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