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(alfuzosin hydrochloride)

Your medicine is available using the name Xatral XL 10mg Tablets
but will be referred to as Xatral XL throughout this leaflet.

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
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.

In this leaflet:


What Xatral XL is and what it is used for
Before you take Xatral XL
How to take Xatral XL
Possible side effects
How to store Xatral XL
Further information

1. What Xatral XL is and what it is used for
The name of your tablets is Xatral XL. This belongs to a group of
medicines called alpha-blockers.
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

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.

2. Before you take Xatral XL

Operations and tests while taking Xatral XL

Do not take Xatral XL if:

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.

You are taking another alpha-blocker. See section below on
‘Taking other medicines’.

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.

You have liver problems.
If you are not sure if any of these apply to you, do not take and
talk to your doctor.

Take special care with Xatral XL

Check with your doctor or pharmacist before taking your medicine

You have chest pain (angina).

You have a condition where your kidneys are hardly working
at all.

You have heart problems, or if your heart suddenly stopped
pumping efficiently (acute cardiac failure).

You have hereditary problems with the way your heart beats
(congenital QTc prolongation).

You are over 65. This is due to the increased sensitivity to
develop hypotension and related adverse reactions in elderly

Taking other medicines

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

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.

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.

Do not take Xatral XL if you are taking:

Other alpha-blockers such as doxazosin, indoramin, prazosin,
terazosin, tamsulosin, or phenoxybenzamine.

Benign Prostatic Hyperplasia

Check with your doctor or pharmacist before taking your medicine

In the past, you have had a large fall in blood pressure while
taking an alpha-blocker (this could include previous use of
alfuzosin. See paragraph immediately above for examples of
other alpha-blockers).

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).

Page 1 of 2

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 go on as before.

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.

Other side effects (frequency not known) which
may occur are:

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.

Other side effects include:
Common (affects less than 1 in 10 people)

Feeling dizzy or faint.
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.
Dry mouth.
Rash and itching.
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

Itchy, lumpy rash also called hives or nettle rash (urticaria).

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
You may get more infections than usual. This could be
caused by a decrease in the number of white blood cells
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:
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store Xatral XL
Keep out of the sight and reach of children.
Do not take this medicine after the month shown on the pack.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage
Store in the original container.
If your medicine appears to be discoloured or shows any other
signs of deterioration, please return to your pharmacist who will
advise you.
If your doctor tells you to stop taking the tablets, return any
unused tablets to the pharmacist for safe disposal.
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.

Page 2 of 2

6. Further information
What Xatral XL contains

Each tablet contains 10mg alfuzosin hydrochloride in a sustained
release formulation.
Your tablets also contain the following inactive ingredients:
ethylcellulose, hypromellose, hydrogenated castor oil,
yellow iron oxide E172, magnesium stearate, microcrystalline
cellulose, povidone, silica colloidal hydrated and mannitol.

What Xatral XL looks like and contents of the pack

Xatral XL are round, yellow/white/yellow tri-layer tablets with no
Xatral XL is available in blister packs of 30 tablets.
Xatral XL is made in a “sustained release” form. This means it
releases the active ingredient gradually and therefore you only
have to take the tablet once a day.


Manufactured by: Sanofi Winthrop Industrie, Tours, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0119


Leaflet revision and issue dated: 13.01.15
Xatral® is a registered trademark of sanofi-aventis.
To request a copy of this leaflet in Braille, large print or audio
please call 01302 552940 and ask for the Regulatory Department.

Expand Transcript

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.