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CARDURA TABLETS 2MG

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

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2. What you need to
know before you take
CARDURA
Do not take CARDURA
– 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 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 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.

UK

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Do not take CARDURA 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 you are affected, do not drive or operate
machinery and contact your doctor immediately.
CARDURA contains lactose
CARDURA contains lactose. If you have been told by your doctor
that you have an intolerance to some sugars contact your doctor
before taking this medicinal product.

3. How to take
CARDURA
Always take this medicine exactly as described in this leaflet or
as your doctor has told you. Check with your doctor, pharmacist
or nurse if you are not sure.
– The recommended dose of CARDURA is one tablet taken once
a day.
– If you are taking CARDURA for the first time the normal dose is
1mg daily. Your doctor may increase this after a couple of weeks
to the usual dose of 2mg or 4mg daily. In some circumstances
this may be increased to a maximum of 8mg daily if you are
being treated for prostate enlargement, or to a maximum of
16mg if you are being treated for high blood pressure.
YOU WILL FIND MORE ABOUT
CARDURA ON THE BACK OF THIS LEAFLET

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Pregnancy, breast-feeding and fertility
The safety of using CARDURA 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.

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CARDURA with food and drink
Please refer to section 3.

typopharma no:

In patients with an enlarged prostate gland, CARDURA is taken to
treat poor and/or frequent passing of urine. This is common in
patients with an enlarged prostate gland. CARDURA works by
relaxing muscle around the bladder exit and prostate gland so
urine is passed more easily.

Other medicines and CARDURA
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
– 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 may lower your blood pressure even more if you are
already taking other medicines to treat high blood pressure.

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

CARDURA 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.

When you start to take CARDURA 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.

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CARDURA 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.

Persistent painful erections may occur very rarely.
If this happens you should contact a doctor immediately.

Replaced no.

1. What CARDURA is
and what it is used for

Before starting treatment with CARDURA your doctor may
perform tests to rule out other conditions such as prostate cancer
that may cause the same symptoms as benign prostatic
hyperplasia (enlargement of the prostate gland).

Mat no.

What is in this leaflet
1. What CARDURA is and what it is used for
2. What you need to know before you take CARDURA
3. How to take CARDURA
4. Possible side effects
5. How to store CARDURA
6. Contents of the pack and other information

If you are undergoing eye surgery because of cataract (cloudiness
of the lens) please inform your eye specialist before the operation
that you are using or have previously used CARDURA. This is
because CARDURA may cause complications during the surgery
which can be managed if your specialist is prepared in advance.

5

• CARDURA 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 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 regularly to get the maximum
benefit, even if you are feeling well.
• Most people do not have serious problems when taking
CARDURA 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,
pharmacist or nurse. 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 and tell your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking CARDURA if:
– you are pregnant or trying to become pregnant
– you have liver disease
– you are also taking other medicines
– you have heart disease

R-Pharm

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.

Corrections / No. of proofs

Tablets
Doxazosin mesilate

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CARDURA® 1mg and 2mg

MOCK GI CAR 1/2MG T
GBR/MLT

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Product

Package leaflet: Information for the patient

MORE INFORMATION ON CARDURA
– CARDURA may be taken in the morning or the evening.
– It is best to take your tablets at about the same time each day
with a drink of water.
– CARDURA can be taken with or without food.
– Take your tablet as your doctor told you or by following the
days and arrows on the blister foil.
– 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.
Use in children
The safety and efficacy of CARDURA in children have not been
established.
If you take more CARDURA than you should
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
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 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:
• Shortness of breath, difficulty breathing (common: may affect
up to 1 in 10 people)
• Increased or decreased heartbeat (common: may affect up to 1
in 10 people)
• Feeling your heartbeat (palpitations) (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)
• 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. 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: 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 bladder (cystitis)
• Sleepiness, general weakness
• Indigestion, heartburn, dry mouth
• Itching
• Back pain, painful muscles
• Flu-like symptoms
Uncommon: 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, increased frequency
in passing urine, blood in urine
• Inflammation of the joints (gout), painful joints, general pain
• Swelling of the face
• Sleeplessness, agitation, anxiety, depression or nervousness
• Reduced or altered sense of touch or sensation of the hands
and feet








Increased appetite or loss of appetite, weight gain
Nose bleeds
Skin rash
Ringing or noise in the ears, tremor
Failure/ inability to achieve penile erection
Liver enzyme increases which may have an effect on some
medical tests
• Stroke
Rare: may affect up to 1 in 1,000 people
• Increased number of times of passing urine
• Muscle cramps, muscle weakness
Very Rare: 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
• Tiredness, generally feeling unwell
• Aggravated wheezing
• Blurred vision
• Hot flushes
• Disorder in passing urine, needing to pass urine at night,
increased volume of urine passed
• 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
the relevant national reporting system detailed below:
UK
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store
CARDURA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and blister after EXP. The expiry date refers
to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack
and other information
What CARDURA contains
The active substance is doxazosin. Each tablet contains either
1.213mg doxazosin mesilate equivalent to 1mg doxazosin or
2.43mg doxazosin mesilate equivalent to 2mg doxazosin.
The other ingredients in each tablet are: magnesium stearate,
microcrystalline cellulose, sodium lauril sulfate, sodium starch
glycollate and lactose (see section 2
CARDURA contains lactose).
What CARDURA looks like and the contents of the pack
The 1mg tablets are white, round and marked with CN1 on one
side and ‘PFIZER’ on the other. The 2mg tablets are white and
oblong and marked with CN2 on one side and ‘PFIZER’ on the
other. They are available in calendar packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road,
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: CR 19_1

Pfizer Limited
Sandwich, England

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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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