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TAURAZIL XL 10 MG TABLETS

Active substance(s): ALFUZOSIN HYDROCHLORIDE / ALFUZOSIN HYDROCHLORIDE / ALFUZOSIN HYDROCHLORIDE

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Package Leaflet: Information for the patient

Taurazil® XL 10 mg
Tablets
(alfuzosin hydrochloride)
For Male Adults
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.
• 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.

What is in this leaflet:

1. What Taurazil XL is and what it is used for
2. What you need to know before you take
Taurazil XL
3. How to take Taurazil XL
4. Possible side effects
5. How to store Taurazil XL
6. Contents of the pack and other information

1. What Taurazil XL is and what it is
used for

and alfuzosin at the same time may
increase the risk of decreasing blood
pressure. Your doctor may stop treating
you with alfuzosin if your angina comes
back or worsens.
• if you were born with, or have had any
condition associated with an abnormal
heart rhythm (which may be seen on
ECG test which looks at the electrical
activity of the heart) or you take medicines
known to affect the heart rhythm.

During treatment
When taking this medicine, you may
experience a sudden drop in blood pressure
when you stand up (you may feel dizzy,
tired, weak or sweaty), particularly in the
first few hours after taking. If this happens,
you should lie down with your legs and
feet up in the air until the symptoms have
disappeared. Usually, these effects last for
only a short time and occur at the start of
the treatment. Normally, there is no need to
stop treatment.
If you need to have eye surgery because
of cataract (cloudiness of the lens) please
inform your eye specialist before the
operation that you are taking or have
previously taken alfuzosin. This is because
alfuzosin may cause complications during
the surgery, which can be managed if your
specialist is prepared in advance.

Taurazil XL contains the active ingredient
alfuzosin, which belongs to a group of
medicines called alpha-adrenoreceptor
antagonists or alpha-blockers.

Children and adolescents

It is used to treat moderate to severe
symptoms caused by an enlarged prostate
gland, a condition that is also called benign
(non-cancerous) prostatic hyperplasia. The
prostate gland lies underneath the bladder.
It surrounds the urethra, the tube that takes
your urine to the outside of the body. If
the prostate gets bigger, it presses on the
urethra making it smaller. Enlarged prostate
glands can cause urinary problems such as
frequent and difficult urination, especially
at night.

Other medicines and Taurazil XL

Alpha-blockers relax the muscles in the
prostate and bladder neck. This allows urine
to flow out of the bladder more easily.

2. What you need to know before
you take Taurazil XL
Do not take Taurazil XL if you:
if you are allergic to alfuzosin, other
quinazoline medicines (e.g. terazosin,
doxazosin) or to any of the other
ingredients of this medicine (listed in
section 6).

if you suffer from conditions that cause
a marked drop in blood pressure when
standing up. (your doctor may have told
you this is called ‘postural’ or ‘orthostatic’
hypotension). This can make you feel dizzy.
• have liver problems.
• take other medicines that belong to the
group known as alpha-blockers (see
below section on ‘Other medicines and
Taurazil XL).

Warnings and precautions

Talk to your doctor or pharmacist before
taking Alfuzosin if you:
• if you have severe kidney problems
• if you take medicines to treat high blood
pressure. In this case your doctor will
check your blood pressure regularly,
especially at the beginning of treatment.
• if you have experienced a marked drop
in blood pressure in the past after taking
another medicine belonging to the
group known as alpha-blockers. In this
case your doctor will start treatment with
alfuzosin at low doses and will gradually
increase the dose.
• if you suffer from heart failure (a
weakness of the heart muscle), or other
heart problems.
• if you have, or have had, problems with
decreased blood flow to parts of the
brain (cerebral circulatory disturbances).
• if you suffer from chest pain (angina) and
are treated with a nitrate. Use of nitrates

Alfuzosin is not recommended for use in
children and adolescents (patients below
16 years of age).
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription.
Do not take Taurazil XL if you are taking
other medicines that belong to the group
known as alpha-blockers, such as doxazosin,
indoramin, terazosin, prazosin or tamsulosin.
Taurazil XL and some medicines may
interfere with each other. Talk to your
doctor or pharmacist if you are taking any
of the following:
• ketoconazole and itraconazole (medicines
used to treat fungal infections)
• medicines used to treat HIV (such
as ritonavir).
• clarithromycin and telithromycin
(medicines to treat bacterial infections).
• nefazodone (a medicine used for
depression).
• medicines to lower blood pressure.
• medicines (nitrates) used to treat the
symptoms of chest pain (angina).
• medicines normally used to treat
impotence (erectile dysfunction).
• The use of Taurazil XL at the same time
as medicines used to treat high blood
pressure, nitrates used to treat heart
problems such as chest pain (angina)
or to treat impotence may lead to low
blood pressure.
If you are going to have an operation that
needs a general anaesthetic, tell your
doctor or hospital staff that you are taking
this medicine. Your doctor may recommend
that you stop taking this medicine 24 hours
before the operation, to help prevent the
risk of blood pressure changes.

Pregnancy and breast-feeding
Taurazil XL should only be used by men.

Driving and using machines
Especially at the beginning of treatment
with Taurazil XL you may feel light-headed,
dizzy or weak. Do not drive or operate
machinery or perform any hazardous tasks
until you know how your body responds to
the treatment.

Taurazil XL 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 Taurazil XL
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
For benign prostatic hyperplasia
The recommended dose is one tablet
(10 mg alfuzosin) once daily.
Take the first tablet at bedtime. Then take
the tablets immediately after the same meal
each day.
Swallow the tablet whole with a sufficient
amount of fluid. Do not crush, powder,
divide or chew the tablets as too much of
the active substance alfuzosin may reach
your body too quickly. This may increase the
risk of unwanted side effects.

If you have kidney problems

If you have mild to moderate kidney
problems, your doctor may recommend
that you start on a lower dose of alfuzosin
first. If a lower dose does not work for you,
then they may recommend that you take
one tablet (10 mg alfuzosin) once daily. Take
the first tablet at bedtime.

stomach pain, feeling sick (nausea),
indigestion, feeling of general weakness,
generally feeling unwell.
Uncommon (may affect up to 1 in 100 people):
Feeling drowsy, vision/eye problems,
faster heartbeat, fainting (especially when
starting treatment with too high a dose or
when treatment is resumed), sensation of
pounding or racing heartbeat, dry mouth,
runny nose, skin rash, itching, urinary
incontinence, water retention (e.g. swelling
of ankles and feet), reddening of the face
or body (flushing/hot flushes), sweating, a
spinning sensation in the head (vertigo),
diarrhoea, marked drop in blood pressure
when standing up (especially when starting
treatment with too high a dose or when
treatment is resumed).
Not known (frequency cannot be estimated
from the available data):
Painful or prolonged erection (priapism),
being sick (vomiting), unexplained bruising
or bleeding (this may be a sign of reduced
number of platelets in the blood, which
help the blood to clot).

If you take large amounts of Taurazil XL your
blood pressure may suddenly drop and you
may feel dizzy or even faint. If you begin
to feel dizzy, sit or lie down until you feel
better. If the symptoms do not disappear,
call your doctor as the drop in blood
pressure may have to be treated in hospital.

If you are having an operation on your eyes
because of cataracts (where the lens of the
eye is cloudy) and are already taking or
have taken alfuzosin in the past, the pupil
may dilate poorly and the iris (the coloured
part of the eye) may become floppy during
the procedure. This only happens during
the operation and it is important for the
eye specialist to be aware of this as the
operation may need to be carried out
differently (see ‘Warnings and precautions’)

If you forget to take Taurazil XL

Reporting of side effects

If you take more Taurazil XL than
you should

Do not take a double dose to make up for a
forgotten tablet as this may cause a sudden
drop in blood pressure. Take the next tablet
as directed.

If you stop taking Taurazil XL

You should not interrupt or stop taking
Taurazil XL without speaking to your
doctor first.
If you want to stop the treatment or have
any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not everybody
gets them.

If you notice any of the following side
effects, stop taking this medicine
and contact your doctor or go to the
nearest hospital casualty department
straight away:

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 Taurazil XL
Do not store above 30°C
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the label and carton
after EXP. The expiry date refers to the last
day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

• worsening of, or new onset of, chest pain
(angina). Normally, this only happens if
you have had angina before.
6. Contents of the pack and other
• red and lumpy skin rash (hives),
information
swelling of the eyelids, face, lips, mouth
or tongue, difficulty in breathing or
What Taurazil XL contains:
swallowing. These are symptoms of
The active substance is alfuzosin
serious allergic reactions.
hydrochloride. One prolonged-release
• an increase in the number of infections
tablet contains 10 mg alfuzosin
(e.g. sore throat, mouth ulcers etc. and
hydrochloride.
fever) that you may get. This may be a
The other ingredients are: lactose
sign of a reduction in the number of
monohydrate, hypromellose, povidone,
white blood cells.
magnesium stearate.
• an unusual or abnormal heart rhythm –
you may notice a very fast or irregular
What Taurazil XL looks like and
heartbeat, which may make you feel
contents of the pack
short of breath, dizzy or faint.
Taurazil XL 10 mg are white, round,
• liver problems, which may be due to a
bevelled-edged, uncoated tablets.
blockage in the bile duct. You may feel
They are available in blister packs of 10, 20,
sick, notice a loss of appetite, pale stools,
30, 50, 60, 60 x 1, 90, 100 tablets.
dark urine or yellowing of the skin and
whites of the eyes.
Not all pack sizes may be marketed.
* sudden collapse, numbness or
Marketing Authorisation Holder
weakness in the arms or leg, dizziness
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
and confusion, disturbances in vision,
United Kingdom.
difficulty swallowing, slurred or loss of
speech (these may be signs of a stroke,
Manufacturer
or mini stroke caused by changes in
Gerard Laboratories
blood supply to parts of the brain).
35/36 Baldoyle Industrial Estate,
These is more likely in patients who
Grange Road, Dublin 13, Ireland
have had previous problems with blood 

flow to the brain..ZMBO)VOHBSZ,GU.ZMBOVUDB),PNBSPN)VOHBSZ


Other possible side effects:

Common (may affect up to 1 in 10 people):
Tiredness, dizziness, headache, faintness,

This leaflet was last revised in:
September 2015

494468

23 Sep 2015

09:16
2/2

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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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