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CARDURA XL 8 MG TABLETS

Active substance(s): DOXAZOSIN / DOXAZOSIN MESILATE

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Cardura® XL 8 mg Tablets

2707
11.11.15[4]

(doxazosin mesilate)
PATIENT INFORMATION LEAFLET
Important things that you SHOULD know about your medicine:
- Cardura XL 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. Do not pass it on to others. It
may harm them, even if their symptoms 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 – see Section 4 for details. If you experience
swelling of the face, tongue or windpipe, see your doctor immediately. If
any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
- 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.
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.
The name of this medicine is Cardura XL 8mg Tablets but will be referred
to as Cardura XL throughout this leaflet.
In this leaflet:
1. What Cardura XL is and what it is used for
2. Before you take Cardura XL
3. How to take Cardura XL
4. Possible side effects
5. Storing Cardura XL
6. Further information
1. WHAT Cardura XL IS AND WHAT IT IS USED FOR
Cardura XL 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. Before you take Cardura XL
Do not take Cardura XL:
- If you have had an allergic reaction in the past to Cardura XL, the active
ingredient doxazosin, other types of quinazolines (such as prazosin or
terazosin), or any of the other ingredients 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 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.
Take special care with Cardura XL:
The following are reasons why Cardura XL 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.
Taking 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.
You should always tell your doctor if you are taking or have recently taken
any other medicine, even those not prescribed, because they might interact
with Cardura XL.
Taking Cardura XL with food and drink:
Cardura XL can be taken with or without food.
Pregnancy:
The safety of using Cardura XL during pregnancy has not been
established. If you are pregnant or trying to become pregnant speak to your
doctor and he/she will decide if Cardura XL is suitable for you.
Breast-feeding:
Do not take Cardura XL if you are breast-feeding.
Driving and using machinery:
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
Cardura XL is a modified 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 usual dose of Cardura XL is one 4mg modified 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.
- Don't change the dose or stop taking the tablets without first checking
with your doctor.
- Don't 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Cardura XL 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
- 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 XL:
- Chest pain, angina
- Shortness of breath, difficulty breathing, wheezing
- Increased, decreased or irregular heartbeat
- Feeling your heartbeat (palpitations)
- Skin rash or itching (especially the whole body)
- Fainting
- Yellowing of the skin or the eyes (jaundice)
- Low numbers of white blood cells or blood platelets, which may result in
bruising or easy bleeding
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
These can affect between 1 in 10 and 1 in 100 patients:
- dizziness, feeling of spinning or rotation of surroundings (vertigo),
headache
- low blood pressure
- swelling of feet, ankles or fingers
- bronchitis, 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:
These can affect between 1 in 100 and 1 in 1,000 patients:
- 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
Very Rare side effects
These can affect less than 1 in 10,000 patients:
- 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
- painful persistent erection of the penis

Other side effects
The frequency of these side effects is unknown:
- 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 “Take special care with Cardura XL”.
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 your tablets out of the sight and reach of children.
Do not use Cardura XL after the expiry date which is stated on carton. 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.
If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Cardura XL contains and its package:
The active substance is doxazosin.
Each modified release tablet contains 8mg doxazosin (as the mesilate).
The other ingredients in each tablet are: polyethylene oxide, sodium
chloride, hypromellose (E464), red iron oxide (E172), titanium dioxide
(E171), magnesium stearate (E470b), cellulose acetate, macrogol,
pharmaceutical glaze, propylene glycol (E1520), black iron oxide (E172).
Cardura XL tablets are white, round, biconvex shaped tablets with a hole in
one side, marked CXL8 on other.
Cardura XL is available in pack sizes of 30 modified release tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Cardura XL is manufactured by
Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35,
89257 Illertissen Germany.
R-Pharm Germany GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen
Germany.
Procured from within the EU by Product Licence holder: Star
Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636/2707

Leaflet revision and issue date (Ref). 11.11.15[4]
Cardura is a trademark of Pfizer.

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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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