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DOXAZOSIN 2MG TABLETS

Active substance(s): DOXAZOSIN MESILATE / DOXAZOSIN MESYLATE / DOXAZOSIN MESILATE / DOXAZOSIN MESYLATE

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PATIENT LEAFLET: INFORMATION FOR THE USER

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, ask your doctor or pharmacist.
• DOXADURA 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 only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• You should take DOXADURA regularly to get the maximum benefit, even if you are feeling
well.
• Most people do not have serious problems when taking DOXADURA but side effects can
occur. If you experience swelling of the face, tongue or windpipe, see your doctor
immediately. If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
• 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 DOXADURA and tell your doctor or
pharmacist.
What is 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:
• are allergic 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
• 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:
Talk to your doctor or pharmacist before taking DOXADURA:
• 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
Children and adolescents
Do not give this medicine to children under 18 years of age since the safety and efficacy of
DOXAZOSIN in this age group have not been established.
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.

Before starting treatment with DOXADURA your doctor may perform tests to rule out other conditions
such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia (enlargement of
the prostate gland).
Persistent painful erections may occur very rarely. If this happens you should contact a doctor
immediately.

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.

Other medicines and DOXADURA:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are some medicines that may interact with 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 alphablocker before you start drugs for erectile dysfunction.
DOXADURA may lower your blood pressure even more if you are already taking other
medicines to treat high blood pressure.

DOXADURA with food and drink
Please refer to section 3.
Pregnancy, breast-feeding and fertility:
The safety of using DOXADURA during pregnancy has not been established. If you are pregnant
or planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine.
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 you are affected, do not drive or operate
machinery and contact your doctor immediately.
DOXADURA contains lactose:
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 recommended 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.

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.
Use in children and adolescents
The safety and efficacy of DOXADURA in children and adolescents have not been established.
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.
If you forget to take DOXADURA: Do not worry. If you forget to take a tablet, leave that dose
out completely. Then go on as before. Do not take a double dose to make up for a forgotten
tablet.

4. POSSIBLE SIDE EFFECTS
Like all medicines, DOXADURA can have side effects although 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:
• Shortness of breath, difficulty breathing (common: may affect up to 1 in 10 people)
• Increased, or decreased heartbeat (common: may affect up to 1 in 10 people)
• Feeling your heartbeat (palpitations) (common: may affect up to 1 in 10 people)
• Chest pain, angina (uncommon: may affect up to 1 in 100 people)

• Irregular heartbeat (very rare: may affect up to 1 in 10,000 people)
• Yellowing of the skin or the eyes (jaundice) (very rare: may affect up to 1 in 10,000 people)
• Low numbers of white blood cells or blood platelets, which may result in increasing frequency
of infection, bruising or easy bleeding (very rare: may affect up to 1 in 10,000 people)
• Persistent painful erection of the penis. Seek urgent medical advice (very rare: may affect up to 1 in
10,000 people)

Other side effects
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 (may affect up to 1 in 10 people)
• Dizziness, feeling of spinning or rotation of surroundings (vertigo), headache
• Low blood pressure
• Swelling of feet, ankles or fingers
• Chest cold, 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 (may affect up to 1 in 100 people)
• 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 (may affect up to 1 in 1,000 people)
• Increased number of times of passing urine
• Muscle cramps, muscle weakness

Very rare (may affect up to 1 in 10,000 people)
• 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

Not known (frequency cannot be estimated from the available data)
• 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 2. “Warnings and precautions”.

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
.Store below 25°C Keep out of the sight and reach 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 July 2017.

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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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