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CARDURA XL 8 MG TABLETS

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

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Package leaflet: information for the User
®

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.
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 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.
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 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 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:
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 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 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 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, HeinrichMack-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.
POM

PL: 18980/0880

Cardura XL 8 mg Tablets

Cardura® is a registered trademark of Pfizer Inc.
Date of leaflet preparation: 17/05/2017

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0330 684 1100 to obtain the
leaflet in a format suitable for you
PIL-0880-S0002

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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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