XATRAL XL TABLETS 10MG

Active substance: ALFUZOSIN HYDROCHLORIDE

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5. How to store Xatral XL

Keep out of the sight and reach of children.

What Xatral XL looks like and contents of
the pack
Your medicine comes as yellow, cylinder
shaped tablets, with a white band around the
middle. Xatral XL Tablets 10 mg are available
as blister packs of 30 tablets.

Do not use Xatral XL after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.

Manufacturer
Sanofi Winthrop Industrie, 30-36 Avenue
Gustave Eiffel, Tours, France.

This medicinal product does not require any
special storage conditions.

Sanofi-Synthelabo Limited, Edgefield Avenue,
Fawdon, Newcastle-Upon-Tyne, NE3 3TT,
UK.
Procured from within the EC. Product Licence
Holder and repackaged by: S.C.A.C. Ltd., Unit
2a, Bandeath Industrial Estate, Throsk,
Stirling, FK7 7NP.

Xatral XL Tablets 10 mg should be stored in
the original container.

If your doctor tells you to stop taking the
tablets, please take them back to the
pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.
If your tablets become discoloured or show
any other signs of deterioration, you should
seek the advice of your pharmacist who will
tell you what to do.
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 to
protect the environment.

6. Further information

POM

PL: 30984/0108
Xatral XL Tablets 10 mg

This leaflet does not contain all the
information about your medicine. If you have
any questions or are not sure about anything,
ask your doctor or pharmacist.
This leaflet was last revised in 23.06.2014
Xatral® is a registered trademark of Sanofi.

What Xatral XL contains
• The active substance is 10 mg alfuzosin
hydrochloride.
• The other ingredients are hypromellose,
hydrogenated castrol oil, ethylcellulose
20, yellow ferric oxide (E172), colloidal
hydrated silica, magnesium stearate,
mannitol, povidone, microcrystalline
cellulose.

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

2. Before you take Xatral XL

Xatral XL Tablets 10 mg

The name of your tablets is Xatral XL. This
belongs to a group of medicines called alphablockers.

Do not take Xatral XL if:
Í You are allergic (hypersensitive) to
alfuzosin or any of the other ingredients of
Xatral XL (see Section 6). Signs of an
allergic reaction include: a rash,
swallowing or breathing problems,
swelling of your lips, throat, or tongue.
Í You are taking another alpha-blocker. See
section below on ‘Taking other
medicines’.
Í You have something called orthostatic
hypotension. This is a drop in blood
pressure which usually happens when
you stand up. It can make you feel dizzy,
light-headed or faint when you stand or sit
up quickly.
Í You have liver problems.
If you are not sure if any of these apply to you,
do not take and talk to your doctor.

(alfuzosin hydrochloride)
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 gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
Your medicine is called Xatral XL Tablets
10 mg, but will be referred to as Xatral XL.
In this leaflet:
1. What Xatral XL is and what it is used for
2. Before you take Xatral XL
3. How to take Xatral XL
4. Possible side effects
5. How to store Xatral XL
6. Further information

Xatral XL can be used to treat the symptoms
of Benign Prostatic Hyperplasia. This is
when the prostate gland enlarges
(hyperplasia), but the growth is not cancerous
(it is benign). It can cause problems in
passing water (urine). This happens mainly in
older men.
• The prostate gland lies underneath the
bladder. It surrounds the urethra. This is
the tube that takes your water to the
outside of the body.
• If the prostate gets bigger, it presses on
the urethra making it smaller. This makes
it difficult to pass water.
• Your tablets work by relaxing the prostate
gland muscle. This allows the urethra to
get bigger and so makes it easier to pass
water.
In a few patients with benign prostatic
hyperplasia, the prostate gland gets so big
that it stops the flow of urine completely.
This is called Acute Urinary Retention.
• This is very painful and you may need a
short stay in hospital.
• A thin, flexible tube (catheter) is passed
into the bladder. This drains the water and
relieves the pain.
• During this time, Xatral XL may be used to
help the water to flow again. This has only
been shown to help in men aged over 65.

Take special care with Xatral XL
Check with your doctor or pharmacist before
taking your medicine if:
p You have chest pain (angina).
p You have a condition where your kidneys
are hardly working at all.
p you have heart problems, or if your heart
suddenly stopped pumping efficiently
(acute cardiac failure)
p you have hereditary problems with the
way your heart beats (congenital QTc
prolongation).
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Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines including medicines obtained
without a prescription.
This is because Xatral XL can affect the way
some other medicines work. Some medicines
can also have an effect on the way that Xatral
XL works.
Do not take Xatral XL if you are taking:
• Other alpha-blockers such as doxazosin,
indoramin, prazosin, terazosin,
tamsulosin, or phenoxybenzamine.
Check with your doctor or pharmacist before
taking your medicine if:
• In the past, you have had a large fall in
blood pressure while taking an alphablocker (this could include previous use of
alfuzosin. See paragraph immediately
above for examples of other alphablockers).
• You are taking a medicine for high blood
pressure, as you may get dizzy, weak or
start sweating within a few hours of taking
this medicine. If this happens, lie down
until the symptoms have completely gone.
Tell your doctor as he or she may decide
to change the dose of your medicine.
Check with your doctor if you are taking any of
the following:
• Medicines for high blood pressure
(hypertension).
• Medicines for chest pain (angina).
• Medicines for fungal infections (such as
ketoconazole or itraconazole) and HIV
(such as ritonavir).

If you stop taking Xatral XL
Keep taking your tablets, even if your
symptoms improve. Only stop if your doctor
tells you to.
The symptoms are better controlled if you
continue taking the same dose of this
medicine.
If you have any further questions on
the use of this product, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, Xatral XL can cause side
effects, although not everybody gets them.
These side effects are most likely to happen
at the start of treatment.
Chest pain (angina)
Normally, this only happens if you
have had angina before. If you get
chest pain stop taking your tablets
and contact a doctor or go to a
hospital immediately. This happens
in less than 1 in 10,000 people.
Allergic reactions
You could notice symptoms of
angioedema, such as a red and lumpy
skin rash, swelling (on the eyelids,
face, lips, mouth and tongue),
difficulty in breathing or swallowing.
These are symptoms of an allergic
reaction. If this happens, stop
taking your tablets and contact a
doctor or go to a hospital
immediately. This happens in less
than 1 in 10,000 people.

Operations and tests while taking Xatral
XL
• if you are going to have an operation on
the eye because of cataract (cloudiness of
the eye'), tell your eye specialist you are
using or have used Xatral XL in the past.
This is because Xatral XL may cause
complications during your operation. This
can be managed if your eye specialist
knows before carrying out the operation
• If you are being treated for high blood
pressure, your doctor should measure
your blood pressure regularly, especially
at the start of treatment.
• If you are going to have an operation that
needs a general anaesthetic, tell your
doctor you are taking Xatral XL before the
operation. Your doctor may decide to stop
you having Xatral XL 24 hours before the
operation. This is because it can be
dangerous as it can lower your blood
pressure.
Taking Xatral XL with food and drink
• Take Xatral XL after a meal.
• You may feel dizzy and weak while taking
Xatral XL. If this happens do not drink any
alcohol.
Driving and using machines
You may feel dizzy and weak while
taking Xatral XL. If this happens do
not drive or operate any tools or
machines.
Important information about some of the
ingredients of Xatral XL
Xatral XL contains hydrogenated castor oil.
This can cause stomach upset and diarrhoea.

3. How to take Xatral XL
Always take Xatral XL exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
• Swallow your tablets whole with plenty of
water.
• Do not break, crush or chew your tablets
This can affect the release of your
medicine into the body.
• Take this medicine after a meal.
Benign Prostatic Hyperplasia
The usual dose is one Xatral XL tablet once a
day.
Acute Urinary Retention
• Xatral XL will be given to you by your
doctor on the day you have the catheter
inserted.
• You should continue taking Xatral XL
once a day.
• You should stop taking Xatral XL the day
after the catheter is removed (3-4 days in
total).
If you take more Xatral XL than you should
Contact your local hospital Accident and
Emergency department straight away. Tell the
doctor how many tablets you have taken. Lie
down as much as possible to help stop the
side effects. Do not try to drive to the hospital
yourself.
If you forget to take Xatral XL
Do not take a double dose to make up for a
forgotten tablet. Miss it out and then go on as
before.

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Other side effects include:
Common (affects less than 1 in 10 people)
• Feeling dizzy or faint.
• Headache.
• Feeling sick (nausea).
• Stomach pain.
• Weakness or tiredness.
Uncommon (affects less than 1 in 100
people)
• Feeling dizzy, lightheaded, or faint when
you stand or sit up quickly (postural
hypotension).
• Fast heart beat (tachycardia) and
palpitations (pounding in the chest and
uneven heartbeat).
• Chest pain.
• Drowsiness.
• Diarrhoea.
• Dry mouth.
• Rash and itching.
• Flushes.
• Water retention (may cause swollen arms
or legs).
• Runny nose, itching, sneezing, and stuffy
nose.
• General feeling of being unwell.
• Problems with your vision
Very rare side effects (affects less than 1
in 10,000 people)
• Itchy, lumpy rash also called hives or
nettle rash (urticaria).

Other side effects (frequency not known)
which may occur are:
• A painful erection of the penis, unrelated
to sexual activity, that will not go away.
• Liver problems. Signs may include
yellowing of your skin or the whites of
your eyes.
• 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 Xatral XL 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 section
'Take special care with Xatral XL')
• You may get more infections than usual.
This could be caused by a decrease in the
number of white blood cells (neutropenia).
• Being sick
• Increased risk of bleeding (including nose
bleeds and/or bleeding gums) and
bruising. This could be a blood problem
called 'thrombocytopenia' which is a
reduced number of platelets in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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.
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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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