Skip to Content

CARDURA XL 8MG MODIFIED RELEASE TABLETS

Active substance(s): DOXAZOSIN / DOXAZOSIN / DOXAZOSIN

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Ref: 1588/040517/1/F

Cardura ® XL 8mg Modified Release Tablets
(doxazosin mesilate)
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.
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.
Your medicine is called Cardura XL 8mg Modified Release Tablets but will be
referred to as Cardura XL throughout this Patient Information Leaflet.
What is in this leaflet
1 What Cardura XL is and what it is used for

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.

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

Cardura XL with food and drink
See section 3 How to take Cardura XL

What Cardura XL is and what it is used for

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.

1

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.

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.

Ref: 1588/040517/1/B

Cardura ® XL 8mg Modified Release Tablets
(doxazosin mesilate)
Patient Information Leaflet (continued)
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 o f 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

Storing Cardura XL

Keep out of the sight and reach of children.
Do not use Cardura XL after the expiry date which is stated on the carton
and the blister after Exp. The expiry date refers to the last day of that month.
Do not store above 30ºC.
Store in the original package in order to protect from moisture.
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.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.

6

Further information

What Cardura XL contains and its package:
The active substance is doxazosin. Each tablet contains 9.70mg doxazosin
mesilate equivalent to 8mg doxazosin.
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.
Cardura XL 8mg tablets are white, round, biconvex shaped with a hole in
one side, marked CXL8 in black ink.
Cardura XL tablets are available in calendar packs of 28 tablets.
Manufacturer and Licence Holder
Manufactured by R-Pharm Germany GmbH, Heinrich-Mack-Str. 35,
89257 Illertissen, Germany and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1588

Cardura XL 8mg Modified Release Tablets

Cardura is a registered trademark of Pfizer Limited.
Revision date: 04/05/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

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.

Hide