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CARDURA 2MG TABLETS

Active substance(s): DOXAZOSIN MESYLATE

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143 LEAFLET Cardura 20151019

PATIENT INFORMATION LEAFLET

CARDURA 2mg TABLETS
DOXAZOSIN TABLETS 2mg
(doxazosin mesilate)
Your medicine is known by the above names but will be referred to
as Cardura throughout the following leaflet.
Information for other strength of Cardura tablets (1mg) also may be
present in this leaflet.
Important things that you SHOULD know about your medicine:


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. Do not pass it on to
others. It may harm them, even if their symptoms 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 – 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 and tell your doctor.

Take special care with Cardura:
The following are reasons why Cardura may not be suitable for you:
-

If you are pregnant or trying to become pregnant

-

If you have liver disease

-

If you are also taking other medicines

-

If you have heart disease

If you are undergoing eye surgery because of cataract (cloudiness
of the lens) please inform your eye specialist before the operation
that you are using or have previously used Cardura. This is
because Cardura may cause complications during the surgery
which can be managed if your specialist is prepared in advance.
If any of these apply to you speak to your doctor before taking this
medicine.
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.
When you start to take Cadura you may experience faintness or
dizziness caused by low blood pressure, when getting up from
sitting or lying down. If you feel faint or dizzy, you should sit or lie
down until you feel better and avoid situations where you might fall
or hurt yourself. Your doctor may want to measure your blood
pressure regularly at the start of therapy to reduce the possibility of
these effects happening.
Taking other medicines:
There are some medicines that may interact with Cardura
-

Some patients who take alpha-blocker therapy for the treatment
of high blood pressure or prostate enlargement may experience
dizziness or light-headedness, which may be caused by low
blood pressure upon sitting or standing up quickly. Certain
patients have experienced these symptoms when taking drugs
for erectile dysfunction (impotence) with alpha-blockers. In
order to reduce the likelihood that these symptoms occur, you
should be on a regular daily dose of your alpha blocker before
you start drugs for erectile dysfunction.

-

Cardura may lower your blood pressure even more if you are
already taking other medicines to treat your high blood pressure
such as terazosin and prazosin.

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 is and what it is used for
2. Before you take Cardura
4. Possible side effects

You should always tell your doctor if you are taking or have recently
taken any other medicine, even those not prescribed, because they
might interact with Cardura.

5. Storing Cardura

Taking Cardura with food and drink:

6. Further information

Cardura can be taken with or without food.

1. WHAT CARDURA IS AND WHAT IT IS USED FOR

Pregnancy:

3. How to take Cardura

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 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 is taken to
treat poor and/or frequent passing of urine. This is common in
patients with an enlarged prostate gland. Cardura works by relaxing
muscle around the bladder exit and prostate gland so urine is
passed more easily.

The safety of using Cardura during pregnancy has not been
established. If you are pregnant or trying to become pregnant speak
to your doctor and he/she will decide if Cardura is suitable for you.
Breast-feeding:
Do not take Cardura if you are breast-feeding.
Driving and using machinery:
Take care if you drive or operate machinery. Your tablets may affect
your ability to drive or operate machinery safely, particularly when
you first start to take them. They may make you feel weak or dizzy.
If affected, do not drive or operate machinery and contact your
doctor immediately.
3. HOW TO TAKE CARDURA

2. BEFORE YOU TAKE CARDURA

-

The usual dose of Cardura is one tablet taken as a single daily
dose each day.

-

If you are taking Cardura for the first time the normal dose is
1mg daily. Your doctor may increase this after a couple of
weeks to the usual dose of 2mg or 4mg daily. In some
circumstances this may be increased to a maximum of 8mg
daily if you are being treated for prostate enlargement, or to a
maximum of 16mg if you are being treated for high blood
pressure.

-

Cardura may be taken in the morning or the evening.

-

It is best to take your tablets at about the same time each day
with a drink of water.

-

Take your tablet as your doctor told you or by following the days
and arrows on the blister foil.

-

If you are still not sure, ask your doctor or pharmacist.

If you have an enlarged prostate gland with one of the following:
any kind of congestion or blockage in your urinary tract, a
longstanding infection of the urinary tract or you have bladder
stones.

-

It is important to keep taking your tablets. They help to control
your blood pressure.

-

Don't change the dose or stop taking the tablets without first
checking with your doctor.

If you have overflow incontinence (you do not feel the urge to
urinate), or anuria (your body is not producing any urine) with or
without kidney problems.

-

Don't wait until your tablets are finished before seeing your
doctor.

Do not take Cardura:
-

If you have had an allergic reaction in the past to Cardura, the
active ingredient doxazosin, other types of quinazolines (such
as prazosin or terazosin) or any of the other ingredients listed in
section 6. This may have been itching, reddening of the skin or
difficulty in breathing.

-

If you are breast-feeding

-

If you are under 18 years of age

-

If you have an enlarged prostate gland (benign prostatic
hyperplasia) and have low blood pressure

-

If you have a history of a condition known as ‘orthostatic
hypotension’ which is a form of low blood pressure that causes
you to feel dizzy or light-headed when you stand up from sitting
or lying down

-

-

If you take more Cardura than you should: Too many tablets at
once may make you unwell. If several tablets are taken it may be
dangerous. Tell your doctor immediately or go to your nearest
hospital casualty department.
If you forget to take Cardura: Do not worry. If you forget to take a
tablet, leave that dose out completely. Then go on as before.

Rare side effects
These can affect between 1 in 1,000 and 1 in 10,000 patients


increased number of times of passing urine



muscle cramps, muscle weakness

Very Rare side effects
These can affect less than 1 in 10,000 patients:

4. POSSIBLE SIDE EFFECTS



Like all medicines, Cardura can cause side effects although not
everybody gets them.

faintness or dizziness caused by low blood pressure when
getting up from a sitting or lying position



hepatitis (liver inflammation) or bile disorder

STOP taking Cardura and call an ambulance immediately if you
experience any of the following:



hives, hair loss, red or purple patches on the skin, bleeding
under the skin



Heart attack



tingling or numbness of the hands and feet



Weakness of arms, legs or problems speaking which may be
symptoms of a stroke



tiredness, generally feeling unwell



aggravated wheezing

Swelling of the face, tongue or throat which may be the result of
an allergic reaction to this medicine



blurred vision



hot flushes



disorder in passing urine, needing to pass urine at night,
increased volume of urine passed



discomfort or enlargement of the breasts in men



painful persistent erection of the penis



Tell your doctor immediately if you experience any of the following
symptoms after taking Cardura:


Chest pain, angina



Shortness of breath, difficulty breathing



Increased, decreased or irregular heartbeat



Feeling your heartbeat (palpitations)



Fainting



Yellowing of the skin or the eyes (jaundice)



Low numbers of white blood cells or blood platelets, which may
result in bruising or easy bleeding

Other side effects
The frequency of these side effects is unknown:


little or no semen ejaculated at sexual climax, cloudy urine
following sexual climax



eye problems may occur during eye surgery for cataract
(cloudiness of the lens of the eye). See section “Take special
care with Cardura”.

The following events have been reported in patients being treated
with Cardura. If any of these side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell your doctor.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

Common side effects

Reporting of side effects:

These can affect between 1 in 10 and 1 in 100 patients:

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.



dizziness, feeling of spinning or rotation of surroundings
(vertigo), headache



low blood pressure



swelling of feet, ankles or fingers



bronchitis, coughing, respiratory tract (nose, throat, lungs)
infection



nasal stuffiness, sneezing and/or runny nose caused by
inflammation of the lining of the nose (rhinitis)



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



stomach/abdominal pains, feeling/being sick



Do not store your tablets above 30°C.



urinary tract infection, urinary incontinence (inability to control
passing urine), inflammation of bladder (cystitis)





sleepiness, general weakness

Do not use Cardura after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



indigestion, heartburn, dry mouth





itching

Tablets should not be thrown in your bin or put down the drain.
If they are out of date, or no longer suitable for you, return them
to your pharmacist.



back pain, painful muscles



flu-like symptoms

Uncommon side effects:
These can affect between 1 in 100 and 1 in 1,000 patients:

By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE CARDURA

6. FURTHER INFORMATION
What Cardura contains


Cardura contains 2mg of doxazosin (as mesilate) as the active
ingredient.



The other ingredients are: lactose, microcrystalline cellulose,
magnesium stearate, sodium starch glycollate and sodium
lauryl sulphate.



constipation, wind, inflammation of the stomach and intestines
(gastroenteritis) which can cause diarrhoea and vomiting



pain or discomfort on passing urine, increased frequency in
passing urine, blood in urine



inflammation of the joints (gout), painful joints, general pain



swelling of the face

Cardura are white, capsule-shaped and marked ‘Pfizer’ on one side
and ‘CN 2’ with a breakline on the other.



sleeplessness, agitation, anxiety, depression or nervousness

Cardura are available in blister packs of 30 tablets.



reduced or altered sense of touch or sensation of the hands
and feet

Product Licence holder



increased appetite or loss of appetite, weight gain



nose bleeds



skin rash



ringing or noise in the ears, tremor



failure/ inability to achieve penile erection



liver enzyme increases which may have an effect on some
medical tests



stroke

What Cardura looks like and contents of the pack

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by R-Pharm Germany GmbH,
Heinrich Mack Strasse 35, D-89257 Illertissen, Germany.
POM

PL: 08747/0143

Leaflet revision date: 19 October 2015
Cardura is a registered trade mark of Pfizer Ltd, UK.
143 LEAFLET Cardura 20151019

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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