Skip to Content



View full screen / Print PDF » Download PDF ⇩

CARDURA® XL 8mg Tablets
(doxazosin mesilate)
This medicine is called Cardura XL 8mg Tablets but will be
referred to as Cardura XL throughout this leaflet. This medicine is
also available in 4mg strength.
Important things that you SHOULD know about your
• Cardura XL is a treatment for high blood pressure, or the
symptoms caused by enlargement of the prostate gland in
• 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 XL regularly to get the maximum
benefit, even if you are feeling well.
• Most people do not have serious problems when taking
Cardura XL 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 XL 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.

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
• 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
If you are undergoing eye surgery because of cataract (cloudiness
of the lens of the eye) please inform your eye specialist before the
operation that you are using or have previously used Cardura XL.
This is because Cardura XL may cause complications during the
surgery which can be managed if your specialist is prepared in
If any of these apply to you speak to your doctor before taking this
When you start to take Cardura XL 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 XL:
• 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 XL 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 XL.

Taking Cardura XL with food and drink:
Cardura XL can be taken with or without food.

1. What Cardura XL is and what it is used for


Cardura XL 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 XL 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 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.

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.

2. Before you take Cardura XL
Do not take Cardura XL:
• If you have had an allergic reaction in the past to Cardura XL, 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 have any form of obstruction of the digestive tract
• 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 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
• 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.

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.

3. How to take Cardura XL
Cardura XL is a modified release tablet. The medicine is contained
within a non-absorbable shell that has been specially
designed to slowly release the medicine. Once swallowed,
doxazosin is slowly released into the body from the tablet, until
the tablet is empty.
Since the empty tablet is eliminated from the body in bowel
movements, you may occasionally observe in the stools,
something that looks like a tablet. This is to be expected and you
should not be concerned.

How to take your medicine
- The usual dose of Cardura XL is one 4mg modified release tablet
taken as a single daily dose each day.
- Your doctor may wish to increase your dose to 8mg. This is the
maximum dose of Cardura XL.
- Swallow Cardura XL whole with water. Do not chew, divide or
crush the tablets.
- Take your tablets 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

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

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.

4. 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
Tell your doctor immediately if you experience any of the following
symptoms after taking CARDURA XL:
• Chest pain, angina
• Shortness of breath, difficulty breathing, wheezing
• Increased, decreased or irregular heartbeat
• Feeling your heartbeat (palpitations)
• Skin rash or itching (especially the whole body)
• 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
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
Common side effects
These can affect between 1 in 10 and 1 in 100 patients:
• dizziness, feeling of spinning or rotation of surroundings (vertigo),
• low blood pressure
• swelling of feet, ankles or fingers
• bronchitis, coughing, respiratory tract (nose, throat, lungs)
• nasal stuffiness, sneezing and/or runny nose caused by
inflammation of the lining of the nose (rhinitis)
• 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 patients:
• 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
• 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 position
• 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”.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

Reporting of side effects
If you get any side effects, tell your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via Yellow Card Scheme Website: By reporting side affects you can
help provide more information on the safety of this medicine.

5. How to store Cardura XL
• Keep out of sight and reach of children.
• Do not use Cardura XL after the expiry date which is stated on
carton, label and blister after “EXP”. The expiry date refers to the
last day of that month.
• Do not store above 30°C.
• Store in the original package in order to protect from moisture.
• The tablets should be whole to work effectively, if you notice any
defects (such as broken tablets) consult your pharmacist
• If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
• 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.

6. Further information
What Cardura XL contains and its package:
The active substance is Doxazosin mesilate.
Each modified release tablet contains 8 mg doxazosin as
doxazosin mesilate.
The other ingredients are polyethylene oxide, sodium chloride,
hypromellose, red ferric oxide (E172), titanium dioxide (E171),
magnesium stearate, cellulose acetate, macrogol, pharmaceutical
glaze, black iron oxide (E172).
Cardura XL 8 mg Tablets are white, round, biconvex shaped with a
hole in one side and marked ‘CXL 8’ in black ink.
Cardura XL 8mg Tablets are available in calendar blister packs of
28 tablets.

Manufacturer and Product Licence Holder
This product is manufactured by R-Pharm Germany GmbH,
Heinrich-Mack-Strasse 35, 89257 Illertissen, Germany. Procured
from within the EU and repackaged by Mediwin Limited.
Product Licence Holder: Mediport Limited,13 Martello Enterprise
Centre, Courtwick Lane, Littlehampton, West Sussex, BN17 7PA,
United Kingdom.


PL: 18980/0880
Cardura XL 8 mg Tablets

Cardura® is a registered trademark of Pfizer Inc.
Date of leaflet preparation: 14/11/2016

Expand view ⇕

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.