XATRAL XL 10MG PROLONGED RELEASE TABLETS

Active substance: ALFUZOSIN HYDROCHLORIDE

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Transcript
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

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.

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help.

alfuzosin hydrochloride

Xatral XL 10 mg
prolonged release tablets

PACKAGE LEAFLET:
INFORMATON FOR THE USER

1

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.

What Xatral XL is and
what it is used for

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)

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.

Before you take Xatral XL

516125_Nt XATRAL 10MG UK.qxp_FORMAT 210x170mm-RL-DBL.qxd 16/06/14 14:40 Page1

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).
2

Important information about some of the
ingredients of Xatral XL
Xatral XL contain hydrogenated castor oil.
This can cause stomach upset and diarrhoea.

You may feel dizzy and weak while taking
Xatral XL. If this happens do not drive or
operate any tools or machines.

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.

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.

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 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.

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).

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

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.

How to take Xatral XL

516125_Nt XATRAL 10MG UK.qxp_FORMAT 210x170mm-RL-DBL.qxd 16/06/14 14:40 Page2

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.

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.

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

Possible side effects

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.

3

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.

Very rare side effects (affects less than 1
in 10,000 people)
• Itchy, lumpy rash also called hives or
nettle rash (urticaria).

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.

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.

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.

• 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.

516125_Nt XATRAL 10MG UK.qxp_FORMAT 210x170mm-RL-DBL.qxd 16/06/14 14:40 Page3

*516125*

What Xatral XL looks like and contents of
the pack
Round biconvex, three layer tablets: one
white layer between two yellow layers. Your
prolonged release tablets are available in
packs of 10, 30, 50, 100 and 500 tablets.
Not all pack sizes may be marketed.

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

Further information

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.

This medicinal product does not require any
special storage conditions.

Keep out of the sight and reach of children.
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.

How to store Xatral XL

© Sanofi 2001 - 2014

4

This leaflet was last revised in June 2014

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37000 Tours
France
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.

516125

516125_Nt XATRAL 10MG UK.qxp_FORMAT 210x170mm-RL-DBL.qxd 16/06/14 14:40 Page4

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.

5. How to store Xatral XL
Keep out of the reach and sight of children.
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.
This medicinal product does not require any
special storage conditions.
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
• The active substance is 10 mg alfuzosin
hydrochloride.
• The other ingredients are ethyl cellulose,
hydrogenated castor oil, hypromellose,
yellow ferric oxide (E172), magnesium
stearate, microcrystalline cellulose, povidone,
colloidal hydrated silica and mannitol.

What Xatral XL looks like and contents of
the pack
Round biconvex, three layer tablets: one
white layer between two yellow layers. Your
prolonged release tablets are available in
packs of 10, 30, 50, 100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 01483 505515
Fax: 01483 535432
Email: uk-medicalinformation@sanofi.com
Manufacturer
Fawdon Manufacturing Centre
Edgefield Avenue, Fawdon,
Newcastle upon Tyne, Tyne and Wear,
NE3 3TT
United Kingdom
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
August 2013
© Sanofi 2001 - 2013

LLET RFED XATRAL 10MG UK

LEAFLET
271
32402710
32402709
60101300
386550
28-AUG-13

32402710
4

2
KY
1 of 2
FRONT 4 BACK 8
148 x 210mm
RFL 26

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Xatral XL 10 mg
prolonged release tablets
alfuzosin hydrochloride

Is this leaflet hard to see or read?
Phone 01483 505515 for help.
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. 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

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

NA
NA
NA

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:
L You have chest pain (angina).
L You have a condition where your kidneys
are hardly working at all.
Turn
Over

1

000
9pt
1
PANTONE
Reflex Blue C

32402710
60101300

L you have heart problems, or if your heart

suddenly stopped pumping efficiently
(acute cardiac failure)
L you have hereditary problems with the way
your heart beats (congenital QTc prolongation).

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
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).
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).

LLET RFED XATRAL 10MG UK

LEAFLET
271
32402710
32402709
60101300

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.
2

386550
28-AUG-13
2
KY
2 of 2
N/A
148 x 210mm
RFL 26

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.
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.
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
Turn
the blood.
Over

3

NA
NA
NA
000
9pt
1
PANTONE
Reflex Blue C

32402710
60101300

Expand view ⇕

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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