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Assessed against the UK PIL dated July 2015

CARDURA® XL 4mg Tablets
(doxazosin mesilate)

Your doctor
By Caroline McDermott
at may want to measure your blood

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 and prostate gland so urine is
passed more easily.

Your medicine is available by the above name, but
will be referred to as Cardura XL throughout the
2. Before you take Cardura XL
remainder of this leaflet. Your medicine is
Do not take Cardura XL:
available in a higher strength of 8mg.
 If you have had an allergic reaction in the past to
Cardura XL, the active ingredient doxazosin, other
Important things that you SHOULD know about
types of quinazolines (such as prazosin or
your medicine:
terazosin), or any of the other ingredients listed in
 Cardura XL is a treatment for high blood pressure,
section 6. This may have been itching, reddening
or the symptoms caused by enlargement of the
of the skin or difficulty in breathing.
prostate gland in men.
 If you are breast-feeding
 This medicine has been prescribed for you. Do not
 If you have any form of obstruction of the digestive
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
 If you are under 18 years of age
 You should take Cardura XL regularly to get the
 If you have an enlarged prostate gland (benign
maximum benefit, even if you are feeling well.
prostatic hyperplasia) and have low blood pressure
 Most people do not have serious problems when
 If you have a history of a condition known as
taking Cardura XL but side effects can occur – see
‘orthostatic hypotension’ which is a form of low
Section 4 for details. If you experience swelling of
blood pressure that causes you to feel dizzy or
the face, tongue or windpipe, see your doctor
light-headed when you stand up from sitting or
immediately. If any of the side effects gets serious,
lying down
or if you notice any side effects not listed in this
 If you have an enlarged prostate gland with one of
leaflet, please tell your doctor or pharmacist.
the following: any kind of congestion or blockage in
 Taking other medicines may sometimes cause
your urinary tract, a longstanding infection of the
problems. Check with your doctor or pharmacist
urinary tract or you have bladder stones.
before taking this or any other medicines.
 If you have overflow incontinence (you do not feel
 If you are, or are trying to become pregnant, do not
the urge to urinate), or anuria (your body is not
take Cardura XL and tell your doctor.
producing any urine) with or without kidney
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 XL is and what it is used for
2. Before you take Cardura XL
3. How to take Cardura XL
4. Possible side effects
5. Storing Cardura XL
6. Further information

Take special care with Cardura XL:
The following are reasons why Cardura XL may not
be suitable for you:
 If you are pregnant or trying to become pregnant
 If you have liver disease
 If you have heart disease
 If you are also taking other medicines

Since the empty tablet is eliminated from the body in
pressure regularly at the start of therapy to reduce the bowel movements, you may occasionally observe in
possibility of these effects happening.
the stools, something that looks like a tablet. This is to
be expected and you should not be concerned.

Taking other medicines:

How to take your medicine
There are some medicines that may interact with
Cardura XL:
 The usual dose of Cardura XL is one 4mg modified
 Some patients who take alpha-blocker therapy for
release tablet taken as a single daily dose each
the treatment of high blood pressure or prostate
enlargement may experience dizziness or
 Your doctor may wish to increase your dose to
light-headedness, which may be caused by low
4mg. This is the maximum dose of Cardura XL.
blood pressure upon sitting or standing up quickly.  Swallow Cardura XL whole with water. Do not
chew, divide or crush the tablets.
Certain patients have experienced these symptoms
when taking drugs for erectile dysfunction
 Take your tablets as your doctor told you or by
(impotence) with alpha-blockers. In order to reduce
following the days and arrows on the blister foil.
the likelihood that these symptoms occur, you
 If you are still not sure, ask your doctor or
should be on a regular daily dose of your alpha
blocker before you start drugs for erectile
 It is important to keep taking your tablets. They
help to control your blood pressure.
 Cardura XL may lower your blood pressure even
 Don’t change the dose or stop taking the tablets
more if you are already taking other medicines to
without first checking with your doctor.
treat your high blood pressure such as terazosin
 Don’t wait until your tablets are finished before
and prazosin.
seeing your doctor.
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 XL.

Taking Cardura XL with food and drink:

If you take more Cardura XL than you should:
Taking 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 immediately.

Cardura XL can be taken with or without food.

If you forget to take Cardura XL:


Do not worry. If you forget to take a tablet, leave that
dose out completely. Then go on as before.

The safety of using Cardura XL 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 XL is suitable for you.

Do not take Cardura XL 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.


Possible side effects

Like all medicines, Cardura XL can cause side effects
although not everybody gets them.
STOP taking Cardura XL and call an ambulance
immediately if you experience any of the following:
 Heart attack
 Weakness of arms, legs or problems speaking
which may be symptoms of a stroke
 Swelling of the face, tongue or throat which may be
the result of an allergic reaction to this medicine

If you are undergoing eye surgery because of
cataract (cloudiness of the lens of the eye) please
Tell your doctor immediately if you experience any of
inform your eye specialist before the operation that
the following symptoms after taking Cardura XL:
you are using or have previously used Cardura XL.
 Chest pain, angina
This is because Cardura XL may cause complications 3. How to take Cardura XL
 Shortness of breath, difficulty breathing, wheezing
1. What Cardura XL is and what it is used
during the surgery which can be managed if your
Cardura XL is a modified release tablet. The medicine  Increased, decreased or irregular heartbeat
specialist is prepared in advance.
is contained within a non-absorbable shell that has
 Feeling your heartbeat (palpitations)
Cardura XL is one of a group of medicines called
been specially designed to slowly release the
If any of these apply to you speak to your doctor
 Skin rash or itching (especially the whole body)
alpha-blockers. It is used to treat high blood pressure,
medicine. Once swallowed, doxazosin is slowly
before taking this medicine.
 Fainting
or the symptoms caused by enlargement of the
released into the body from the tablet, until the tablet  Yellowing of the skin or the eyes (jaundice)
prostate gland in men. Cardura XL can be used to
When you start to take Cardura XL you may
is empty.
 Low numbers of white blood cells or blood
treat high blood pressure (hypertension), by relaxing
experience faintness or dizziness caused by low
platelets, which may result in bruising or easy
blood vessels so that blood passes through them
blood pressure, when getting up from sitting or lying
more easily.
down. If you feel faint or dizzy, you should sit or lie
This helps to lower blood pressure.
down until you feel better and avoid situations where
you might fall or hurt yourself.

The following events have been reported in patients
being treated with Cardura XL. 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
 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
 stomach/abdominal pains, feeling/being sick
 urinary tract infection, urinary incontinence (inability
to control passing urine), inflammation of the
bladder (cystitis)
 sleepiness, general weakness
 indigestion, heartburn, dry mouth
 back pain, painful muscles
 flu-like symptoms

Uncommon side effects:
These can affect between 1 in 100 and 1 in 1,000
 constipation, wind, inflammation of the stomach
and intestines (gastroenteritis) which can cause
diarrhoea and vomiting
 pain or discomfort on passing urine, needing to
pass urine more often than usual, blood in urine
 inflammation of the joints (gout), painful joints,
general pain
 swelling of the face
 sleeplessness, anxiety, depression
 reduced or altered sense of touch or sensation of
the hands and feet
 increased appetite or loss of appetite, weight gain
 nose bleeds
 ringing in the ears, tremor
 failure/ inability to achieve penile erection
 abnormal results for blood tests which show
changes in the way the liver is working

Very Rare side effects
These can affect less than 1 in 10,000 patients:
 faintness or dizziness caused by low blood
pressure when getting up from a sitting or lying
 hepatitis (liver inflammation) or bile disorder
 hives, hair loss, red or purple patches on the skin,
bleeding under the skin
 tingling or numbness of the hands and feet
 agitation, nervousness
 tiredness, generally feeling unwell
 aggravated wheezing

muscle cramps, muscle weakness
blurred vision
disorder in passing urine, needing to pass urine at
night, increased volume of urine passed, increased
production of urine causing an increase in the
number of times of passing urine
discomfort or enlargement of the breasts in men
painful persistent erection of the penis

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 XL”.

Reporting of side effects
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:
By reporting side effects, you can help provide more
information on the safety of this medicine.


How to store Cardura XL

Keep out of the sight and reach of children.
Do not store above 30°C.
Store in original package.
Do not use Cardura XL after the expiry date which is
stated on carton. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
If your medicine becomes discoloured or shows any
signs of deterioration, you should seek the advice of
your pharmacist.
The tablets should be whole to work effectively, if you
notice any defects (such as broken tablets) consult
your pharmacist immediately.


Further information

What Cardura XL contains and its package:
The active substance is Doxazosin. Each modified
release tablet contains 4mg doxazosin as doxazosin
The other ingredients are
Active layer of the Tablet core: polyethylene oxide
(55-75 cps), hypromellose (5 cps), red ferric oxide
(E172) and magnesium stearate.
Osmotic layer: polyethylene oxide (5500-7500 cps),
sodium chloride, hypromellose (5 cps), red ferric
oxide (E172) and magnesium stearate.
Tablet coating: cellulose acetate and macrogol 3350.
Film: Opadry white (YS – 7063) and black printing ink

What Cardura XL looks like and contents of the
White, round, biconvex shaped tablets with a hole in
one side and marked ‘CXL4’.
They are available in the calendar pack of 28 tablets.
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35,
89257 Illertissen
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon,
London, NW9 6AQ.
PL 33902/0599
Leaflet revision date: 27/01/2016
Cardura® is a registered trademark of PFIZER

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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.