DOXAZOSIN TABLETS 2MG

Active substance: DOXAZOSIN MESYLATE

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Take special care with Cardura:
The following are reasons why Cardura may not be suitable for you:
• If you are pregnant or trying to become pregnant
• If you have liver disease
• If you are also taking other medicines
• If you have heart disease
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.
If any of these apply to you speak to your doctor before taking this medicine.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.
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.

DT

14/11/12

ARTWORKER:

DATE OF PROOF:
6464/0315 B
CODE:

UK PIL DATED DECEMBER 2011
MULTIPLE MANUFACTURERS

04-1957
PRE-PRESS NO.:

Cardura 2mg tabs
PRODUCT:

Taking 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 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.
Taking Cardura with food and drink:
Cardura can be taken with or without food.
Pregnancy:
The safety of using Cardura 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 is suitable for you.
Breast-feeding:
Do not take Cardura 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
The usual dose of Cardura is one tablet taken as a single daily dose each 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.
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.
Take your tablet as your doctor told you.
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 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 miss a dose of Cardura: Do not worry. If you forget to take a tablet, leave that dose out completely.
Then go on as before.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

DATE:

2. Before you take Cardura
Do not take Cardura:
• If you have had an allergic reaction in the past to Cardura, 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 are under 16 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.

DATE:

CUSTOMER
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1. What Cardura is and what it is used for
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.
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.
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.

CUSTOMER: Waymade

Q.A.
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This product is known as the above names, but will be referred to as Cardura throughout this leaflet. Another
strength (1mg) is also available.
Important things that you SHOULD know about your medicine:
• 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. Do not pass it on to others. It may harm them, even if their
symptoms 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 – 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 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.
In this leaflet:
1. What Cardura is and what it is used for
2. Before you take Cardura
3. How to take Cardura
4. Possible side effects
5. Storing Cardura
6. Further information

PROOF HISTORY:
v.1 - waymade - 14/11/12

Leaflet Flat Size = 148 x 432

27mm

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

CARDURA® 2mg TABLETS/DOXAZOSIN TABLETS 2mg
(Doxazosin mesilate)
Patient Information Leaflet

DATE:
14/11/12
DATE OF PROOF:

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
• 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
• painful persistent erection of the penis

UK PIL DATED DECEMBER 2011
MULTIPLE MANUFACTURERS

6464/0315 B

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”.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor.

CODE:

Q.A.
APPROVED:
DT

PRE-PRESS NO.:

04-1957

PRODUCT:

CUSTOMER: Waymade

Cardura 2mg tabs

ARTWORKER:

Rare side effects
These can affect between 1 in 1,000 and 1 in 10,000 patients
• increased number of times of passing urine
• muscle cramps, muscle weakness







5. How to store Cardura
Cardura 2mg Tablets/Doxazosin Tablets 2mg should be stored below 30°C.
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist.

6. Further information
Your medicine is called Cardura 2mg Tablets/Doxazosin Tablets 2mg. Each tablet contains 2mg of the
active ingredient, Doxazosin (as Mesilate). It is a white, oblong tablet marked with ‘CN’ and ‘2’ either side of
a breakline on one side, and marked with a Pfizer logo on the other side.
Cardura 2mg Tablets/Doxazosin Tablets 2mg also contain the following:
Lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate, sodium lauryl sulphate.
Cardura 2mg Tablets/Doxazosin Tablets 2mg are available in blister packs of 30 tablets.
POM

PL No: 6464/0315 Cardura 2mg tablets/Doxazosin 2mg tablets

This product is manufactured by Pfizer/Roerig Farmaceutica, ITALIANA SRL S.S. 156km 47, 415 04100
Latina, Italy, or, Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse, IIIertissen, Germany and
procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 6.11.2012
Cardura is a registered trademark of PFIZER Ltd.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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, 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

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 14/11/12

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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
• itching
• back pain, painful muscles
• flu-like symptoms

WARNING!

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.

WARNING!

Tell your doctor immediately if you experience any of the following symptoms after taking Cardura:
• Chest pain, angina
• Shortness of breath, difficulty breathing
• Increased, decreased or irregular heartbeat
• Feeling your heartbeat (palpitations)
• 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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

4. Possible side effects
Like all medicines, Cardura 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

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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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