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.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your
doctor or your pharmacist.
• This medicine has been prescribed for you
personally and you should not pass it onto others.
It may harm them, even if their symptoms are the
same as yours.
• 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.
In this leaflet:
1. What DOXADURA is and what it is used for
2. Before you take DOXADURA
3. How to take DOXADURA
4. Possible side effects
5. Storing DOXADURA
6. Further 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

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.

Taking other medicines:
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.

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.

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.

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 16 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

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.

2. BEFORE YOU TAKE DOXADURA

Take special care with DOXADURA:
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

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.

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

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.
Children:
This medicine is not recommended for children.

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.

5. STORING 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. FURTHER 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 August 2014.

DSC-DOX-PIL-072_05
20/08/2014

Type of Print (ie Litho) Litho

Format

155 x 300 mm

Expand view ⇕

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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