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Active substance: DOXAZOSIN MESYLATE

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Read all of this leaflet carefully before you start
surgery which can be managed if your specialist is
taking this medicine because it contains important
prepared in advance.
information for you.
If any of these apply to you speak to your doctor before
• Keep this leaflet. You may need to read it again.
taking this medicine.
• If you have any further questions, please ask your
When you start to take DOXADURA you may
doctor or pharmacist.
experience faintness or dizziness caused by low blood
• This medicine has been prescribed for you only. Do
pressure, when getting up from sitting or lying down. If
not pass it on to others. It may harm them, even if
you feel faint or dizzy, you should sit or lie down until
their signs of illness are the same as yours.
you feel better and avoid situations where you might
• If you get any side effects, talk to your doctor or
fall or hurt yourself.
pharmacist. This includes any possible side effects
Your doctor may want to measure your blood pressure
not listed in this leaflet. See section 4.
regularly at the start of therapy to reduce the possibility
In this leaflet:
of these effects happening.
1. What DOXADURA is and what it is used for
Other medicines and DOXADURA:
2. What you need to know before you take
Some patients who take alpha-blocker therapy for the
treatment of high blood pressure or prostate
3. How to take DOXADURA
enlargement may experience dizziness or light
4. Possible side effects
headedness, which may be caused by low blood
5. How to store DOXADURA
pressure upon sitting or standing up quickly. Certain
6. Contents of the pack and other information
patients have experienced these symptoms when
The name of your medicine is DOXADURA 1 mg
taking drugs for erectile dysfunction (impotence) with
Tablets, DOXADURA 2 mg Tablets, DOXADURA 4 mg
alpha-blockers. In order to reduce the likelihood that
Tablets (referred to as DOXADURA throughout this
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
Doxazosin is one of a group of medicines called
blood pressure such as terazosin or prazosin.
Please inform your doctor or pharmacist if you are
DOXADURA tablets are used to treat high blood
taking or have recently taken any other medicines,
pressure (hypertension) or the symptoms caused by
even those not prescribed.
enlargement of the prostate gland in men.
Taking DOXADURA with food and drink
In patients taking DOXADURA to treat high blood
DOXADURA can be taken with or without food.
pressure (hypertension) DOXADURA works by relaxing
blood vessels so that blood passes through them more
easily. This helps to lower blood pressure.
The safety of using DOXADURA during pregnancy has
In patients with enlargement of the prostate gland,
not been established. If you are pregnant or trying to
DOXADURA is taken to treat frequent and/or poor
become pregnant speak to your doctor and he/she will
passing of urine. This is common in patients with
decide if DOXADURA is suitable for you.
enlargement of the prostate gland. DOXADURA works
by relaxing muscle around the bladder exit and
Do not take DOXADURA if you are breast-feeding.
prostate gland so urine is passed more easily.
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
Do not take DOXADURA if you:
take them. They may make you feel weak or dizzy. If
• have ever had an allergic reaction (hypersensitivity)
affected, do not drive or operate machinery and
to doxazosin, other types of quinazolines (such as
contact your doctor immediately.
prazosin or terazosin) or any of the other ingredients
Important information about some of the
of DOXADURA tablets listed in section 6. This may
ingredients of DOXADURA:
have been itching, reddening of the skin or difficulty
This medicine contains lactose. If you have been told
in breathing.
by your doctor that you have an intolerance to some
• are breastfeeding
sugars, contact your doctor before taking this
• 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

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
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.
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
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
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.

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
• 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
• 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
• 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
• 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:
By reporting side effects you can help provide more
information on the safety of this medicine.

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.

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 August 2015.

30/07 /2015

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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.