Cardura 1mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOXAZOSIN

Available from:

Pfizer Hellas S.A.

ATC code:

C02CA04

INN (International Name):

DOXAZOSIN

Pharmaceutical form:

TABLET

Composition:

DOXAZOSIN 1 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIHYPERTENSIVES

Authorization status:

Authorised

Authorization date:

2006-02-06

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARDURA
®
1MG TABLETS
CARDURA
®
2MG TABLETS
Doxazosin 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 frequent pa

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CARDURA 1mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxazosin mesilate
1.213mg equivalent to 1mg doxazosin.
Excipient with known effect:
Each tablet contains 40mg of lactose monohydrate.
Each tablet contains 0.06 mg sodium.
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:_
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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 max