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CARDURA XL 8MG TABLETS

Active substance(s): DOXAZOSIN / DOXAZOSIN MESILATE / DOXAZOSIN / DOXAZOSIN MESILATE

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Cardura® XL 8mg Tablets
(doxazosin mesilate)

Your medicine is known by the above name, but will be referred to as Cardura
XL throughout this leaflet. This medicine is also available in 4mg strength.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness 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. If you experience swelling of the face, tongue or
windpipe, see your doctor immediately. If you get any side effects, talk
to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
• 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 or pharmacist.
What is in this leaflet
1) What Cardura XL is and what it is used for
2) What you need to know before you take Cardura XL
3) How to take Cardura XL
4) Possible side effects
5) How to store Cardura XL
6) Contents of the pack and other information

1) What Cardura XL is and what it is used for
Cardura XL contains the active substance doxazosin mesilate and 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.

2) What you need to know before you take Cardura XL
Do not take Cardura XL:
• If you are allergic to doxazosin, other types of quinazolines (such as
prazosin or terazosin), or any of the other ingredients of this medicine (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 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
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cardura XL as it 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.
Persistent painful erections may occur very rarely. If this happens you should
contact a doctor immediately.
Before starting treatment with Cardura XL your doctor may perform tests to
rule out other conditions such as prostate cancer that may cause the same
symptoms as benign prostatic hyperplasia.

Children and adolescents
Cardura XL is not recommended for use in children or adolescents below 18
years as safety and efficacy have not yet been established. Benign prostate
hyperplasia is not relevant in children.
Other medicines and Cardura XL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any 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 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 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.
Cardura XL with food and drink
See section 3 How to take Cardura XL
Pregnancy, breast-feeding and fertility
The safety of using Cardura XL during pregnancy has not been established. If
you are pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take Cardura XL if you are breast-feeding.
Driving and using machines
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
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Cardura XL is a prolonged 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 recommended dose of Cardura XL is one 4mg prolonged 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.
• Do not change the dose or stop taking the tablets without first checking with
your doctor.
• Do not 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. Do not take a double dose to make up for a forgotten
tablet.

4) Possible side effects
Like all medicines, this medicine 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
• Allergic reactions (hypersensitivity). Symptoms include sudden
wheeziness, tightness in the chest, difficulty in breathing, swelling of the
face, tongue or throat, rash or itching (especially the whole body)
Tell your doctor immediately if you experience any of the following symptoms
after taking Cardura XL:
• Feeling your heartbeat (palpitations) (common: may affect up to 1 in 10
people)
• Increased or decreased heartbeat (common: may affect up to 1 in 10
people)

• Shortness of breath, difficulty breathing, wheezing (common: may affect
up to 1 in 10 people)
• Chest pain, angina (uncommon: may affect up to 1 in 100 people)
• Irregular heartbeat (very rare: may affect up to 1 in 10,000 people)
• Skin rash or itching (especially the whole body) (uncommon: may affect up
to 1 in 100 people)
• Yellowing of the skin or the eyes (jaundice) (very rare: may affect up to 1
in 10,000 people)
• Low numbers of white blood cells or blood platelets, which may result in
bruising or easy bleeding (very rare: may affect up to 1 in 10,000 people)
• Persistent painful erection of the penis. Seek urgent medical advice (very
rare: may affect up to 1 in 10,000 people)
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: may affect up to 1 in 10 people
• dizziness, feeling of spinning or rotation of surroundings (vertigo),
headache
• low blood pressure
• swelling of feet, ankles or fingers
• chest cold, 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: may affect up to 1 in 100 people
• 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
Rare side effects: may affect up to 1 in 1,000 people
• blockage of the digestive tract
Very Rare side effects: may affect up to 1 in 10,000 people
• 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
Not known: frequency cannot be estimated from the available data
• 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 “warnings and precautions”.
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:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5) How to store Cardura XL






Keep out of the sight and reach of children.
Do not use Cardura XL after the expiry date which is stated on carton
label or blister strip. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package. Protect from
moisture.
The tablets should be whole to work effectively, if you notice any defects
(such as broken tablets) consult your pharmacist immediately.
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) Contents of the pack and other information
What Cardura XL contains:
The active substance is Doxazosin mesilate.
Each modified release tablet contains 8 mg doxazosin as doxazosin mesilate.
Cardura XL also contain the following ingredients:
Tablet core: polyethylene oxide, sodium chloride,
hydroxypropylmethylcellulose red iron oxide (E172) and magnesium stearate.
Tablet coating: cellulose acetate, macrogol 3350,
hydroxypropylmethylcellulose, titanium dioxide (E171), printing ink (shellac,
black iron oxide (E172), isopropyl alcohol, ammonium hydroxide and
propylene glycol).
What Cardura XL looks like and contents of the pack
The tablets are white, round, film-coated and printed ‘CXL8’ on one side with
a hole on the reverse.
Cardura XL 8mg Tablets are available in calendar blister packs of 28 tablets.
PL 10383/2170

Cardura XL 8mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by R-Pharm Germany GmbH,
Heinrich-Mack-Str 35, 89257 Illertissen, Germany. Procured from within the
EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 18.04.2017
Cardura is a trademark of Pfizer Products Inc., USA.

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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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