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CARDURA TABLETS 2MG

Active substance(s): DOXAZOSIN / DOXAZOSIN MESYLATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CARDURA® 1mg and 2mg

In this leaflet:
1. What CARDURA is and what it is used for
2. Before you take CARDURA
3. How to take CARDURA
4. Possible side effects
5. Storing CARDURA
6. Further information

CARDURA is
? 1. Wandhatwhat
it is used for
CARDURA is one of a group of medicines called alphablockers. 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.

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2. BEFORE YOU TAKE
CARDURA

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

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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 CARDURA 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 lightheadedness, 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.
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.
Taking CARDURA with food and drink:
CARDURA can be taken with or without food.
Pregnancy:
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.

YOU WILL FIND MORE ABOUT
CARDURA ON THE BACK OF THIS LEAFLET

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UK

– 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.
– 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.

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Important things that you SHOULD know about your
medicine:
1 CARDURA is a treatment for high blood pressure,
or the symptoms caused by enlargement of the
prostate gland in men.
1 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.
1 You should take CARDURA regularly to get the
maximum benefit, even if you are feeling well.
1 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.
1 Taking other medicines may sometimes cause
problems. Check with your doctor or pharmacist
before taking this or any other medicines.
1 If you are, or are trying to become pregnant, do not
take CARDURA 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.

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Tablets
Doxazosin mesilate

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MORE INFORMATION ON CARDURA

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3. HOW TO TAKE
CARDURA

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4. POSSIBLE SIDE
EFFECTS

Like all medicines, CARDURA can cause side effects
although not everybody gets them.
STOP taking CARDURA and call an ambulance
immediately if you experience any of the following:
1 Heart attack
1 Weakness of arms, legs or problems speaking which
may be symptoms of a stroke
1 Swelling of the face, tongue or throat which may be the
result of an allergic reaction to this medicine
Tell your doctor immediately if you experience any of
the following symptoms after taking CARDURA:
1 Chest pain, angina
1 Shortness of breath, difficulty breathing
1 Increased, decreased or irregular heartbeat
1 Feeling your heartbeat (palpitations)
1 Fainting
1 Yellowing of the skin or the eyes (jaundice)
1 Low numbers of white blood cells or blood platelets,
which may result in bruising or easy bleeding
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.
Common side effects
These can affect between 1 in 10 and 1 in 100 patients:
1 dizziness, feeling of spinning or rotation of surroundings
(vertigo), headache
1 low blood pressure
1 swelling of feet, ankles or fingers
1 bronchitis, coughing, respiratory tract (nose, throat,
lungs) infection
1 nasal stuffiness, sneezing and/or runny nose caused by
inflammation of the lining of the nose (rhinitis)
1 stomach/abdominal pains, feeling/being sick
1 urinary tract infection, urinary incontinence (inability to
control passing urine), inflammation of bladder (cystitis)
1 sleepiness, general weakness
1 indigestion, heartburn, dry mouth
1 itching
1 back pain, painful muscles
1 flu-like symptoms
Uncommon side effects:
These can affect between 1 in 100 and 1 in 1,000 patients:
1 constipation, wind, inflammation of the stomach and
intestines (gastroenteritis) which can cause diarrhoea
and vomiting
1 pain or discomfort on passing urine, increased
frequency in passing urine, blood in urine
Pfizer Limited
Sandwich, England

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general pain

1 swelling of the face
1 sleeplessness, agitation, anxiety, depression or

nervousness

1 reduced or altered sense of touch or sensation of

the hands and feet

1 increased appetite or loss of appetite, weight gain
1 nose bleeds
1 skin rash
1 ringing or noise in the ears, tremor
1 failure/ inability to achieve penile erection
1 liver enzyme increases which may have an effect on

some medical tests

1 stroke

Rare side effects
These can affect between 1 in 1,000 and 1 in
10,000 patients
1 increased number of times of passing urine
1 muscle cramps, muscle weakness
Very Rare side effects
These can affect less than 1 in 10,000 patients:
1 faintness or dizziness caused by low blood pressure
when getting up from a sitting or lying position
1 hepatitis (liver inflammation) or bile disorder
1 hives, hair loss, red or purple patches on the skin,
bleeding under the skin
1 tingling or numbness of the hands and feet
1 tiredness, generally feeling unwell
1 aggravated wheezing
1 blurred vision
1 hot flushes
1 disorder in passing urine, needing to pass urine at night,
increased volume of urine passed
1 discomfort or enlargement of the breasts in men
1 painful persistent erection of the penis

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

1 inflammation of the joints (gout), painful joints,

Other side effects
The frequency of these side effects is unknown:
1 little or no semen ejaculated at sexual climax, cloudy
urine following sexual climax
1 eye problems may occur during eye surgery for cataract
(cloudiness of the lens of the eye). See section “Take
special care with CARDURA”.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.

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5. H
 OW TO STORE 
CARDURA

Keep your tablets out of the reach and sight of children.
Do not use CARDURA after the expiry date which is
stated on carton. The expiry date refers to the last day
of that month.
Do not store above 30°C.

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6. FURTHER 
INFORMATION

What CARDURA contains and its package:
The active substance is Doxazosin. Each tablet contains
either 1.213mg doxazosin mesilate equivalent to 1mg
doxazosin or 2.43mg doxazosin mesilate equivalent to
2mg doxazosin.
The other ingredients in each tablet are: magnesium
stearate, microcrystalline cellulose, sodium lauril sulfate,
sodium starch glycollate and lactose.
The 1mg tablets are white, round and marked with CN1
on one side and ‘PFIZER’ on the other. The 2mg tablets
are white and oblong and marked with CN2 on one side
and ‘PFIZER’ on the other. They are available in packs of
28 tablets.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent,
CT13 9NJ, United Kingdom
Manufacturer
R-Pharm Germany GmbH,
Heinrich-Mack-Str. 35, 89257 Illertissen, Germany
This leaflet was last revised in 07/2015.
Ref: CR 17_3 UK

571900M

14.07.15 14:28

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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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