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CARDURA XL 4MG

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

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2. What you need to know
before you take CARDURA XL

Do not take CARDURA XL:

1 If you are allergic to doxazosin, other types of quinazolines

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(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:
1 If you are pregnant or trying to become pregnant
1 If you have liver disease

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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

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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.

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

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See section 3 How to take CARDURA XL

typopharma no:

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CARDURA XL with food and drink

Typopharma GmbH
Mühlestr. 57
D-79539 Lörrach
produktion@typopharma.com
www.typopharma.com

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.

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:
1 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.
1 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.

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

Other medicines and CARDURA XL

Mat no.

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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.

Product

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 If you have heart disease
1 If you are also taking other medicines

R-Pharm

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
1 Keep this leaflet you may need to read it again.
1 If you have any further questions, ask your doctor or
pharmacist.
1 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.
1 You should take CARDURA XL regularly to get the maximum
benefit, even if you are feeling well.
1 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.
1 Taking other medicines may sometimes cause problems.
Check with your doctor or pharmacist before taking this or
any other medicines.
1 If you are, or are trying to become pregnant, do not take
CARDURA XL and tell your doctor or pharmacist.

Prolonged release tablets

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Doxazosin mesilate

Laetus-Code: ###

CARDURA XL 4mg and 8mg

Replaced no.

®

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Package leaflet: Information for the patient

MORE INFORMATION ON CARDURA XL

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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:
1 Heart attack
1 Weakness of arms, legs or problems speaking which may be
symptoms of a stroke
1 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
1 dizziness, feeling of spinning or rotation of surroundings (vertigo),
headache
1 low blood pressure
1 swelling of feet, ankles or fingers
1 chest cold, coughing, respiratory tract (nose, throat, lungs)
infection
1 nasal stuffiness, sneezing and/or runny nose caused by
inflammation of the lining of the nose (rhinitis)
1 stomach/abdominal pains, feeling/being sick
1 urinary tract infection, urinary incontinence (inability to
control passing urine), inflammation of the bladder (cystitis)
1 sleepiness, general weakness
1 indigestion, heartburn, dry mouth
1 back pain, painful muscles
1 flu-like symptoms
Uncommon side effects: may affect up to 1 in 100 people
1 constipation, wind, inflammation of the stomach and intestines
(gastroenteritis) which can cause diarrhoea and vomiting
1 pain or discomfort on passing urine, needing to pass urine more
often than usual, blood in urine
1 inflammation of the joints (gout), painful joints, general pain
1 swelling of the face
1 sleeplessness, anxiety, depression
1 reduced or altered sense of touch or sensation of the hands and feet
1 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
1 blockage of the digestive tract
Very Rare side effects: may affect up to 1 in 10,000 people
1 faintness or dizziness caused by low blood pressure when getting
up from a sitting or lying position
1 hepatitis (liver inflammation) or bile disorder
1 hives, hair loss, red or purple patches on the skin, bleeding under
the skin
1 tingling or numbness of the hands and feet
1 agitation, nervousness
1 tiredness, generally feeling unwell
1 aggravated wheezing
1 muscle cramps, muscle weakness
1 blurred vision
1 flushing
1 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
1 discomfort or enlargement of the breasts in men
Not known: frequency cannot be estimated from the
available data
1 little or no semen ejaculated at sexual climax, cloudy urine
following sexual climax
1 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
report side effects directly via the 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.
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Keep this medicine out of the sight and reach of children.
Do not use CARDURA XL after the expiry date which is stated on
carton 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.
The tablets should be whole to work effectively, if you notice any
defects (such as broken tablets) consult your pharmacist
immediately.
Do not throw away any medicines via wastewater or household
waste. Ask you pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

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6. Contents of the pack
and other information

What CARDURA XL contains
The active substance is doxazosin. Each tablet contains either
4.85mg doxazosin mesilate equivalent to 4mg doxazosin or
9.70mg doxazosin mesilate equivalent to 8mg doxazosin within
a shell that has been specially designed to slowly release the drug.
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), ammonium hydroxide and propylene
glycol.
What CARDURA XL looks like and contents of the pack
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 4mg and 8mg prolonged release
tablets and in packs of 28 or 30 tablets. Not all pack sizes may be
marketed.

Marketing Authorisation Holder and
Manufacturer

Marketing authorisation Holder
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.
Manufacturer
R-Pharm Germany GmbH,
Heinrich-Mack-Str. 35, 89257 Illertissen, Germany.
This leaflet was last revised in 02/2017.
Ref: CX 15_1

Pfizer Limited
Sandwich, England

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5. How to store
CARDURA XL

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By signing this artwork copy the market confirms
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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

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.

Expand Transcript

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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