CARDURA XL 4MG

Active substance: DOXAZOSIN MESILATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CARDURA XL 4 mg and 8 mg Tablets
®

Doxazosin mesilate

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. This leaflet was last
updated in December 2011.

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

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

CARDURA XL 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 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.

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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 16 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
stones.

UNITED KINGDOM

• 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.
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
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
advance.
If any of these apply to you speak to your doctor before taking this
medicine.
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.
Pregnancy:
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.
Breast-feeding:
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

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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.

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

By signing this artwork copy the market confirms
that this document has been checked completely,
i.e. the correctness of all aspects (text, dosage
values, spelling, font size etc.) is certified. In case
of alterations the concerned parts must be marked
clearly. The market approval of this document
authorizes the plant to print the contents of this
proof. The market takes full responsibility for
correctness of this print proof

Important things that you SHOULD know about your
medicine:
• CARDURA XL 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 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.

PFI_K5_521860_GBR_CXL 4/8 mg T ROLLE 25.03.12 17:59 Seite 2

MORE INFORMATION ON CARDURA XL

– The usual dose of CARDURA XL is one 4 mg modified release
tablet taken as a single daily dose each day.
– Your doctor may wish to increase your dose to 8 mg. 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
doctor.
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.
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.

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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
doctor.
Common side effects
These can affect between 1 in 10 and 1 in 100 patients:
• 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)
• 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
feet

Pfizer Limited
Sandwich, England

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
• flushing
• 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.






5. How to store
CARDURA XL

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Keep your tablets out of the reach and sight of children.
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.
Do not store above 30 °C.
Store in the original package.
The tablets should be whole to work effectively, if you notice any
defects (such as broken tablets) consult your pharmacist immediately.

6. Further
information

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What CARDURA XL contains and its package:
The active substance is Doxazosin. Each tablet contains either
4.85 mg doxazosin mesilate equivalent to 4 mg doxazosin or
9.70 mg doxazosin mesilate equivalent to 8 mg doxazosin within a
shell that has been specially designed to slowly release the drug.
The other ingredients in each tablet are: polyethylene oxide,
sodium chloride, hypromellose, red ferric oxide (E172), titanium
dioxide (E171), magnesium stearate, cellulose acetate, Macrogol,
pharmaceutical glaze, black iron oxide (E172), ammonium
hydroxide and propylene glycol.
CARDURA XL tablets are white, round, biconvex shaped with
a hole in one side and marked CXL 4 for the 4mg and CXL 8 for
the 8mg.
They are available in strengths of 4 mg and 8 mg modified release
tablets and in packs of 28 tablets.
Marketing Authorisation Holder
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.
Manufacturer
Pfizer Manufacturing Deutschland GmbH,
Heinrich-Mack-Strasse 35, 89257 Illertissen, Germany.
Date last revised: December 2011
Ref: CX8_0 UK

521860

By signing this artwork copy the market confirms
that this document has been checked completely,
i.e. the correctness of all aspects (text, dosage
values, spelling, font size etc.) is certified. In case
of alterations the concerned parts must be marked
clearly. The market approval of this document
authorizes the plant to print the contents of this
proof. The market takes full responsibility for
correctness of this print proof

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How to take
your medicine

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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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