DOXAZOSIN 1MG TABLETS

Active substance: DOXAZOSIN MESYLATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Doxadura 1mg, 2mg and 4mg Tablets
Doxazosin Mesilate
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 any further questions, ask your doctor or pharmacist.
- 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.
- If any of the side-effects get 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 Tablets are and what they are
used for
2. Before you take Doxadura Tablets
3. How to take Doxadura Tablets
4. Possible side-effects
5. How to store Doxadura Tablets
6. Further information
1. What Doxadura Tablets are and what they are
used for
The active ingredient in your tablets, doxazosin,
belongs to a group of medicines known as alpha-1
antagonists. Doxadura is used to treat the following
conditions:
- High blood pressure. If left uncontrolled, high
blood pressure can increase the risk of heart
disease or stroke.
Doxadura works by widening your blood vessels
making it easier for your heart to pump blood
through them. This helps to lower raised blood
pressure and reduce the risk of heart disease.
2. Before you take Doxadura Tablets
Do not take Doxadura Tablets
- if you have ever suffered an allergic reaction to
the active ingredient, doxazosin, or any of the
other ingredients listed at the end of the leaflet.
Allergic reactions may be, for example, itching,
reddening of the skin or difficulty breathing
- if you know that you are sensitive to
quinazolines (e.g. prazosin, terazosin).
Quinazolines is the chemical family of medicines
to which doxazosin belongs.
- if you are breast-feeding
- if you have any form of obstruction of the
digestive tract
- if you have a history of blood pressure dropping
on standing
- if you suffer from an enlarged prostate gland
- if you have a problem with your bladder or
passing urine
- if you are under 16 years of age.
Take special care with Doxadura Tablets
- if you have liver problems
- if you have a heart condition
- if you have a disorder of the blood vessels of
the brain
- if you have a tendency to fainting or dizziness
(hypotension)
- if you suffer from accumulation of fluid on the
lungs.
Before surgery and anaesthesia (even at the
dentist), you should tell the doctor or dentist that
you are taking Doxadura Tablets.
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 Tablets. This is because Doxadura
Tablets may cause complications during the
surgery which can be managed if your
specialist is prepared in advance.
Taking other medicines
Tell your doctor if you are already taking any of the
following:
- Non-steroidal
anti-inflammatory
drugs
(NSAIDs), e.g. ibuprofen
- Other medicines used in the treatment of high
blood pressure, e.g. ramipril, bisoprolol,
nifedipine, tamsulosin
- Oestrogens (female hormones)
- Dopamine,
ephedrine,
adrenaline,
metaraminol, methoxamine, phenylephrine
(medicines used for the treatment of heart
problems)
- Drugs called monoamine oxidase inhibitors
(MAOI's) used to treat depression
- Drugs used for the treatment of erection
problems
(PDE-5
inhibitors,
e.g.
sildenafil (viagra), tadalafil, vardenafil).
Some patients who take alpha-blocker therapy for
the treatment of high blood pressure or prostate

enlargement may experience dizziness or lightheadedness, which may be caused by low blood
pressure upon sitting or standing up quickly. Certain
patients have experienced these symptoms when
taking drugs for erection problems (impotence) with
alpha-blockers such as Doxadura. In order to
reduce the likelihood of these symptoms occurring,
you should be on a regular daily dose of your alphablocker before you start drugs for erection
problems.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Taking Doxadura with food and drink
Doxadura can be taken with or after food.
Pregnancy and breast-feeding
Do not take Doxadura if you are pregnant, trying to
become pregnant or if you are breast-feeding.
Speak to your doctor first.
Driving and using machines
Doxadura may influence your ability to drive and
use machines. If you feel dizzy or light-headed, you
must not drive or operate machinery. Be especially
careful when you take your first dose or if your dose
is increased. Also be careful if you are starting to
take your medicine again after not having taken it
for some time.
Important information about the ingredients of
Doxadura Tablets
Doxadura tablets contain lactose. If you have been
told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this
medicinal product. Doxadura 2 and 4mg tablets
also contain the colouring agent sunset yellow FCF
(E110). This ingredient may cause allergic
reactions.
3. How to take Doxadura Tablets
You must keep taking your Doxadura Tablets
exactly as your doctor has told you. The
directions should be given on the label. You
should check with your doctor or pharmacist if
you are not sure.
Adults and the elderly
Doxadura is taken once daily. The dose is adjusted
according to your blood pressure decrease and
your response to Doxadura. The initial dose is 1mg
once daily. Thereafter the dose will be gradually
increased (e.g. 2, 4 or 8mg daily) for up to four
weeks. The maximum daily dose of Doxadura is
16mg. Doxadura can 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.
Children
Doxadura should not be used in children under 16
years of age.
If you take more Doxadura Tablets than you
should
If you take too many tablets you should lie down on
your back with your feet higher than your head. The
most likely symptoms of overdose would be a
feeling of light-headedness or dizziness due to a fall
in blood pressure. If you have any of these
symptoms you should tell your doctor or pharmacist
or go to your accident and emergency department
immediately.
If you forget to take Doxadura Tablets
If you miss a dose, do not worry. Simply take the
next day’s tablet when it is due. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Doxadura Tablets
Keep taking your tablets until your doctor tells you
to stop.

Please read the back of this leaflet.

*Trademark

4. Possible side-effects
Like all medicines, Doxadura can cause sideeffects, although not everybody gets them.
The evaluation of the side-effects is based on the
following frequencies:
Not known:

Very rare:

Rare:

Uncommon:

Common:

Very common:

Frequency cannot be
estimated from the available
data
In less than 1 in 10,000
patients treated, including
single reports
In less than 1 in 1,000, but
more than 1 in 10,000
patients treated
In less than 1 in 100, but
more than 1 in 1,000
patients treated
In less than 1 in 10, but
more than 1 in 100 patients
treated
In more than 1 in 10 patients
treated

If you experience any of the following very rare or
uncommon unwanted effects you should tell your
doctor immediately:
- slow heartbeat
- bronchial spasms (wheezing and tightness in the
chest)
- raised red patches on the skin
- increased passing of urine
- excessive urination at night
- changes in the number of cells in the blood,
which may result in easy bleeding
- blurred vision
- jaundice (yellowing of the skin)
- hepatitis (inflammation of the liver)
- blocked bile flow (yellowing of the skin, clay or
white coloured faeces, stomach pain)
- abnormal liver function tests
- development of breasts in males
- painful persistent erection in males.
Uncommon side-effects include:
- ringing or noise in the ears
- increased appetite
- wind
- being sick
- gastroenteritis (upset stomach)
- delayed or difficult passage of faeces
- pain
- muscle cramps
- muscle weakness
- gout (painful inflammation of the joints)
- painful joints
- trembling or shaking
- reduced sense of touch
- fainting
- stroke (sudden loss of consciousness)
- nosebleed
- a feeling of irregular heartbeat
- angina pectoris (sudden brief attacks of pain in
the centre of the chest)
- heart attack
- facial swelling
- loss of hair
- skin rash
- purple rash caused by bleeding under the skin
- pain when passing urine or a change to the
frequency of urination
- urinary incontinence (leakage of urine)
- increased volume of urine passed
- blood in the urine
- hot flushes (redness of the face)
- allergic drug reaction
- weight increase
- abnormal liver function tests
- agitation
- depression
- erection problems.
Other side-effects whose frequency is not known
include:
- little or no semen ejaculated at sexual climax in
males; cloudy urine following sexual climax
- altered sense of taste or loss of taste
- Intraoperative Floppy Iris Syndrome (leads to
problems in cataract surgery).
However you should tell your doctor if any of the
following common symptoms are severe or become
troublesome:
- vertigo (a feeling of dizziness or ‘spinning’)
- mouth dryness
- stomach pain
- diarrhoea (upset stomach)
- feeling sick or being sick
- indigestion (difficulty digesting food and a
burning sensation at top of stomach)
- malaise (feeling unwell)
- flu-like symptoms

-

oedema (swelling)
fatigue
weakness
painful muscles and back pain
headache
dizziness
postural dizziness (dizziness as a result of
getting up from a sitting or lying position)
- drowsiness
- insomnia (inability to sleep)
- sensation of prickling or tingling on the skin with
unknown cause
- cough
- difficulty in breathing
- bronchitis
- nasal stuffiness and/or runny nose
- infection in the lungs, windpipe or urinary tract
- heart palpitations
- increased heart rate
- chest pain
- itching
- cystitis
- inability to pass urine
- low blood pressure
- anorexia (loss of appetite)
- nervousness.
If any of the side-effects get serious, or if you notice
any side-effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. How to store Doxadura Tablets
Keep out of the reach and sight of children.
Do not use Doxadura Tablets after the expiry date
which is stated on the blister and carton after EXP.
The expiry date refers to the last day of the month.
Store below 25°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help protect the
environment.
6. Further information
What Doxadura Tablets contain
The active substance is doxazosin mesilate.
The other ingredients are microcrystalline cellulose,
lactose monohydrate, sodium starch glycolate,
magnesium stearate, sodium lauryl sulphate and
colloidal silicon dioxide.
Sunset yellow FCF (E110) is an additional
ingredient present in the 2mg and 4mg tablets.
What Doxadura Tablets look like and the
contents of the pack
Doxadura 1mg tablets are white to off-white
biconvex uncoated tablets, scored with a division
mark and embossed with ‘DZS1’ on one side.
Doxadura 2mg tablets are light orange to pink
biconvex uncoated tablets, scored with a division
mark and embossed with ‘DZS2’ on one side.
Doxadura 4mg tablets are light orange to pink
biconvex uncoated tablets, scored with a division
mark and embossed with ‘DZS4’ on one side.
They are supplied in cartons of 28 or 56 tablets in
foil blister strips.

POM
PL 06831/0091
PL 06831/0092
PL 06831/0093

Doxadura 1mg Tablets
Doxadura 2mg Tablets
Doxadura 4mg Tablets

Marketing Authorisation Holder:
Genus Pharmaceuticals
Park View House, 65 London Road, Newbury
Berkshire RG14 1JN, UK.
Manufacturer:
Synthon BV
Microweg 22, 6545 CM Nijmegen
The Netherlands.
Synthon Hispania SL
Castello 1, Poligono Las Salinas
08830 Sant Boi de Llobregat, Spain.
Distributed by:
Discovery Pharmaceuticals
The Old Vicarage, Market Place
Castle Donington, Derbyshire DE74 2JB, UK.
This leaflet was last approved in
June 2011.

xxxxxxx xxxx
*Trademark

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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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