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XATRAL XL 10MG TABLETS

Active substance(s): ALFUZOSIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

XATRAL® XL 10MG TABLETS





(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
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.

In this leaflet:
1.
2.
3.
4.
5.
6.

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
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.

2. Before you take 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 if:

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 patients.
You ever get painful erections of the penis, unrelated to
sexual activity that will not go away, before or during
treatment.

Taking other medicines

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.

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.

If you have any further questions on the use of this product,
ask your doctor or pharmacist.

Do not take Xatral XL if you are taking:

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

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.

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 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.

Chest pain (angina)

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).

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.

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

4. Possible side effects

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.

Painful erection of the penis (priapism)

If you get painful erections of the penis, unrelated to sexual
activity, that will not go away stop taking your tablets and
contact a doctor or go to a hospital immediately.
Frequency not known.

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






Uncommon (affects less than 1 in 100 people)























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.

Page 1 of 2

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

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

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).

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)

The usual dose is one Xatral XL tablet once a day.


Feeling dizzy or faint.
Headache.
Feeling sick (nausea).
Stomach pain.
Weakness or tiredness.




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 or search for
MHRA Yellow Card in the Google Play or Apple App Store.
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
conditions.
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.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name: XATRAL XL
10MG TABLETS
Reference No: 08929/0119

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.

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 markings.
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.

Manufacturer

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

POM

Leaflet revision and issue dated: 04.12.17
Xatral® is a registered trademark of sanofi-aventis.
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.

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+ 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.

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