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DOXAZOSIN 1MG TABLETS

Active substance: DOXAZOSIN MESYLATE

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PATIENT INFORMATION LEAFLET

DOXADURA 1 mg TABLETS
DOXADURA 2 mg TABLETS
DOXADURA 4 mg TABLETS
Doxazosin
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, please 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.
• 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.
In this leaflet:
1. What DOXADURA is and what it is used for
2. What you need to know before you take
DOXADURA
3. How to take DOXADURA
4. Possible side effects
5. How to store DOXADURA
6. Contents of the pack and other information
The name of your medicine is DOXADURA 1 mg
Tablets, DOXADURA 2 mg Tablets, DOXADURA 4 mg
Tablets (referred to as DOXADURA throughout this
leaflet).

1. WHAT DOXADURA IS AND WHAT IT IS
USED FOR
Doxazosin is one of a group of medicines called
alpha-blockers.
DOXADURA tablets are used to treat high blood
pressure (hypertension) or the symptoms caused by
enlargement of the prostate gland in men.
In patients taking DOXADURA to treat high blood
pressure (hypertension) DOXADURA works by relaxing
blood vessels so that blood passes through them more
easily. This helps to lower blood pressure.
In patients with enlargement of the prostate gland,
DOXADURA is taken to treat frequent and/or poor
passing of urine. This is common in patients with
enlargement of the prostate gland. DOXADURA 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 DOXADURA
Do not take DOXADURA if you:
• have ever had an allergic reaction (hypersensitivity) to
doxazosin, other types of quinazolines (such as
prazosin or terazosin) or any of the other ingredients
of DOXADURA tablets listed in section 6. This may
have been itching, reddening of the skin or difficulty
in breathing.
• are breastfeeding
• are aged under 18 years of age
• have an enlarged prostate gland (benign prostatic
hyperplasia) and have low blood pressure
• 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
• 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
• 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:
The following are reasons why DOXADURA may not be
suitable for you:
• If you have liver disease
• If you are pregnant or trying to become pregnant
• 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 DOXADURA. This is because
DOXADURA 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 DOXADURA 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.
Children and adolescents
DOXAZOSIN is not recommended for use in children or
adolescents below 18 years as safety and efficacy have
not yet been established.
Other medicines and DOXADURA:
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.
DOXADURA may lower your blood pressure even more
if you are already taking other medicines to treat your
blood pressure such as terazosin or prazosin.
Please inform your doctor or pharmacist if you are
taking or have recently taken any other medicines, even
those not prescribed.
Taking DOXADURA with food and drink
DOXADURA can be taken with or without food.
Pregnancy:
The safety of using DOXADURA 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 DOXADURA is suitable for you.
Breastfeeding:
Do not take DOXADURA 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.
Important information about some of the ingredients
of DOXADURA:
This medicine contains lactose. If you have been told by
your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE DOXADURA
Use in adults and elderly:
Always take DOXADURA exactly as your doctor has
instructed you. You should check with your doctor or
pharmacist if you are unsure.
DOXADURA is usually taken once daily. DOXADURA
may be taken in the morning or the evening.
You can take your tablets before or after food.
You should take your tablets at the same time each day
with a small amount of water.
The initial dose of DOXADURA is 1mg once daily.
Thereafter the dose may be gradually increased (within
1-2 weeks interval) to the usual dose (2mg or 4mg
daily).
In some circumstances the dose 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.
Use in children and adolescents:
DOXADURA is not recommended for use in children or
adolescents below 18 years as safety and efficacy have
not yet been established.
You have been given a calendar pack that will help you
remember to take your tablets. If you are taking more

than one tablet a day, you must ignore the marking for
the day, printed on the back of the blister.
Because high blood pressure is treated in order to
prevent problems from arising, you may have no
symptoms at all while taking DOXADURA. Even if this is
so and you feel well, you should not stop taking your
blood pressure medication unless instructed to by your
doctor.
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 have impression that the effect of DOXADURA is
too strong or too weak, talk to your doctor or
pharmacist.
If you forget to take DOXADURA:
If you miss a dose just carry on with the next one as
normal. Do not take a double dose to make up for the
missed one.
If you take more DOXADURA 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, DOXADURA can have side effects
but not everybody gets them.
STOP taking DOXADURA 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 DOXADURA:
• 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 increasing frequency of infection,
bruising or easy bleeding
The following events have been reported in patients
being treated with doxazosin. 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 bladder
(cystitis)
• Sleepiness, general weakness
• Indigestion, heartburn, dry mouth
• Itching
• 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, 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 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
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
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 DOXADURA”.
If any of the side effects become serious, or you notice
any side effects not mentioned in this leaflet, please
inform your doctor or pharmacist.
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 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 DOXADURA

There are no special precautions for storage. Keep out
of the reach and sight of children.
Check the expiry date on the label. Do not use the
tablets if the expiry date has passed.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What DOXADURA contains
The active substance is: doxazosin. Each tablet
contains 1mg, 2mg, or 4mg of doxazosin (as mesilate).
The other ingredients are: Lactose monohydrate,
magnesium stearate, microcrystalline cellulose, sodium
lauryl sulphate, sodium starch glycolate (type A) and
colloidal anhydrous silica.
What DOXADURA looks like and contents of
the pack
DOXADURA comes in three different strengths:
Doxadura 1 mg tablet is a round white to off-white
tablet scored on one side.
Doxadura 2 mg tablet is a white to off-white
capsule-shaped tablet scored on one side.
Doxadura 4 mg tablet is a white to off-white
capsule-shaped tablet, scored on both sides, with
embossement “D4” on one side.
Doxadura 1 mg, 2 mg and 4 mg tablets are available in
calendar packs of 28 tablets in foil blister strips.
The manufacturer / holder of the marketing
authorization is:
Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire, NN11 8PB, UK
Manufactured for:
Discovery Pharmaceuticals, The Old Vicarage, Market
Place, Castle Donington, Derbyshire
DE74 2JB, England
This leaflet was last revised in March 2015.

DSC-DOX-PIL-085_01
27/03/2015

155 x 300 mm

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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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