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ALFUZOSIN HYDROCHLORIDE 2.5MG TABLETS

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

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Xatral® 2.5mg
Tablets
(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.

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

Check with your doctor or pharmacist before
taking your medicine if:






1. What Xatral is and
what it is used for



The name of your tablets is Xatral. This
belongs to a group of medicines called
alpha-blockers.
Xatral can be used to treat the symptoms of
Benign Prostatic Hypertrophy. 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.

2. Before you take Xatral



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 before the
operation. Your doctor may decide to
stop you having Xatral 24 hours before
the operation.
This is because it can be dangerous as it
can lower your blood pressure.

Taking Xatral with food and drink


You may feel dizzy and weak while taking
Xatral. If this happens do not drink any
alcohol.

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

Important information about some
of the ingredients of Xatral
If you have been told by your doctor that you
have an intolerance to some sugars contact
your doctor before taking this medicinal
product.

3. How to take Xatral
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 can affect the way
some other medicines work. Some medicines
can also have an effect on the way that
Xatral works.
Do not take Xatral 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:


Do not take Xatral if:
 You are allergic (hypersensitive) to
alfuzosin or any of the other ingredients
of Xatral (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 chest pain (angina).
You have a long-term infection in your
urinary tract (including your kidney,
bladder and urethra), had difficulty when
passing water or had small crystals
(stones) forming in the water.
If you are going to have an operation on
the eye called ‘Cataract (cloudiness of
the eye’), tell your eye specialist you are
using or have used Xatral in the past.
This is because Xatral may cause
complications during your operation. This
can be managed if your eye specialist
knows before carrying out the operation.
You have circulatory problems affecting
the brain as there is a risk of impaired
brain function due to low blood flow.
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
increases risk of developing hypotension
and related adverse reaction in elderly
patients.

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

Take special care with Xatral

In this leaflet:
What Xatral is and what it is used for
Before you take Xatral
How to take Xatral
Possible side effects
How to store Xatral
Further information






The name of your medicine is Xatral 2.5mg
Tablets but will be referred to as Xatral
throughout this leaflet.
1.
2.
3.
4.
5.
6.

Check with your doctor if you are taking any
of the following:



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.

Always take Xatral 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.

The usual dose is one Xatral three times a
day.

If you are over 65 or are being treated
for high blood pressure


You should start on one Xatral in the
morning and one tablet in the evening.

If you have kidney problems


You should start on one Xatral twice a
day. This may be changed depending
upon how you respond.

If you have liver problems


You should start on one Xatral a day.
This may be changed to two tablets a
day, depending upon how you respond.

If you take more Xatral 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.








Rash and itching.
Flushes.
Water retention (may cause swollen arms
or legs).
Lack of control over passing water.
Runny nose, itching, sneezing, and stuffy
nose.
Visual disturbances (changes in your
vision or sight).
Fainting.

If you forget to take Xatral



Do not take a double dose to make up for a
forgotten tablet. Miss it out and then go on as
before.

Very rare side effects (affects less than
1 in 10,000 people)


If you stop taking Xatral
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 include:
Common (affects less than 1 in 10
people)










Feeling dizzy or faint.
Headache.
Feeling sick (nausea).
Stomach pain.
Weakness or tiredness.
General feeling of being unwell.
Feeling dizzy, lightheaded, or faint when
you stand or sit up quickly (postural
hypotension).
Diarrhoea.
Dry mouth.

Uncommon (affects less than 1 in 100
people)




Fast heart beat (tachycardia) and
palpitations (pounding in the chest and
uneven heartbeat).
Chest pain.
Drowsiness.

The active substance is 2.5mg alfuzosin
hydrochloride.
Xatral also contain lactose, microcrystalline
cellulose, povidone, sodium starch glycollate,
magnesium stearate, hypromellose,
macrogol 400 and titanium dioxide (E171).



Xatral are white, round, film-coated tablets
marked ‘ALZ’ on one side and ‘2.5’ on the
reverse.




Chest pain (angina)

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.

What Xatral contains

What Xatral looks like and contents
of the pack

Like all medicines, Xatral can cause side
effects, although not everybody gets them.
These side effects are most likely to happen
at the start of treatment.

Allergic reactions

6. Further information

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

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.

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

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.








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.
Intraoperative Floppy Iris Syndrome
(IFIS). 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 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
(neutropenia).
Being sick (vomiting).
Abnormal heart rhythm.
Impaired brain function due to low blood
flow in patients with existing circulatory
problems affecting the brain.
Increased risk of bleeding (including nose
bleed 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.

5. How to store Xatral
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original
package.
Do not take the tablets after the expiry date
which is stated on the carton and blister
labels after ‘Exp’. The expiry date refers to
the last day of that month.
If the tablets become discoloured or show
any signs of deterioration, seek the advice of
your pharmacist.
Remember if your doctor tells you to stop
taking this medicine, return any unused
medicine to your pharmacist for safe
disposal. Only keep this medicine if your
doctor tells you to.

They are available in packs of 30 tablets.

Manufactured by: Sanofi-Winthrop
Industrie, 30-36 Avenue Gustave Eiffel,
Tours, France.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
POM
Xatral® 2.5mg Tablets; PL 18799/1345
Leaflet date: 25.05.2017
Xatral is a registered trademark of
Sanofi-aventis.

Blind or partially
sighted ?
Is this leaflet hard to
see or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Alfuzosin
hydrochloride
2.5mg Tablets
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 Alfuzosin hydrochloride is and what
it is used for
2. Before you take Alfuzosin hydrochloride
How to take Alfuzosin hydrochloride
3. Possible side effects
4. How to store Alfuzosin hydrochloride
5. Further information
The name of your medicine is Alfuzosin
hydrochloride 2.5mg Tablets but will be
referred to as Alfuzosin hydrochloride
throughout this leaflet.

1. What Afluzosin
hydrochloride is and
what it is used for
The name of your tablets is Afluzosin
hydrochloride. This belongs to a group of
medicines called alpha-blockers.
Afluzosin hydrochloride can be used to treat
the symptoms of Benign Prostatic
Hypertrophy. 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.

2. Before you take Alfuzosin
hydrochloride

Do not take Alfuzosin
hydrochloride if:
 You are allergic (hypersensitive) to
alfuzosin or any of the other ingredients
of Alfuzosin hydrochloride (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 serious 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
Alfuzosin hydrochloride
Check with your doctor or pharmacist before
taking your medicine if:
You have chest pain (angina).
You have a long-term infection in your
urinary tract (including your kidney,
bladder and urethra), had difficulty when
passing water or had small crystals
(stones) forming in the water.
 If you are going to have an operation on
the eye called ‘Cataract (cloudiness of
the eye’), tell your eye specialist you are
using or have used Alfuzosin
hydrochloride in the past. This is because
Alfuzosin hydrochloride may cause
complications during your operation. This
can be managed if your eye specialist
knows before carrying out the operation.
 You have circulatory problems affecting
the brain as there is a risk of impaired
brain function due to low blood flow.
 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
increases risk of developing hypotension
and related adverse reaction in elderly
patients.

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 Alfuzosin hydrochloride can
affect the way some other medicines work.
Some medicines can also have an effect on
the way that Alfuzosin hydrochloride works.
Do not take Alfuzosin hydrochloride 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 chest pain (angina)
Medicines for fungal infections (such as
ketoconazole or itraconazole) and HIV
(such as ritonavir).

Operations and tests while taking
Alfuzosin hydrochloride




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 Alfuzosin
hydrochloride before the operation. Your
doctor may decide to stop you having
Alfuzosin hydrochloride 24 hours before
the operation.
This is because it can be dangerous as it
can lower your blood pressure.

Taking Alfuzosin hydrochloride
with food and drink


You may feel dizzy and weak while taking
Alfuzosin hydrochloride. If this happens
do not drink any alcohol.

Driving and using machines
You may feel dizzy and weak while taking
Alfuzosin hydrochloride. If this happens do
not drive or operate any tools or machines.

Important information about some
of the ingredients of Alfuzosin
hydrochloride
If you have been told by your doctor that you
have an .intolerance to some sugars contact
your doctor before taking this medicinal
product.

3. How to take Alfuzosin
hydrochloride
Always take Alfuzosin hydrochloride 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.
The usual dose is one Alfuzosin
hydrochloride three times a day.

If you are over 65 or are being treated
for high blood pressure
 You should start on one Alfuzosin
hydrochloride in the morning and one
tablet in the evening.

If you have kidney problems
 You should start on one Alfuzosin
hydrochloride twice a day. This may be
changed depending upon how you
respond.

If you have liver problems
 You should start on one Alfuzosin
hydrochloride a day. This may be changed
to two tablets a day, depending upon how
you respond.









Feeling sick (nausea).
Stomach pain.
Weakness or tiredness.
General feeling of being unwell.
Feeling dizzy, light-headed, or faint when
you stand or sit up quickly (postural
hypotension).
Diarrhoea.
Dry mouth.

Uncommon (affects less than 1 in 100
people)

If you take more Alfuzosin
hydrochloride 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 Alfuzosin
hydrochloride




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 Alfuzosin
hydrochloride

Very rare side effects (affects less than
1 in 10,000 people)

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.








4. Possible side effects
Like all medicines, Alfuzosin hydrochloride
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.

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

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


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

Fast heart beat (tachycardia) and
palpitations (pounding in the chest and
uneven heartbeat).
Chest pain.
Drowsiness.
Rash and itching.
Flushes.
Water retention (may cause swollen arms
or legs).
Lack of control over passing water.
Runny nose, itching, sneezing, and stuffy
nose.
Visual disturbances (changes in your
vision or sight).
Fainting.








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.
Intraoperative Floppy Iris Syndrome
(IFIS). 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
hydrochloride 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 Alfuzosin hydrochloride’).
You may get more infections than usual.
This could be caused by a decrease in
the number of white blood cells
(neutropenia).
Being sick (vomiting).
Abnormal heart rhythm.
Impaired brain function due to low blood
flow in patients with existing circulatory
problems affecting the brain.
Increased risk of bleeding (including nose
bleed 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.

5. How to store Alfuzosin
hydrochloride
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original
package.
Do not take the tablets after the expiry date
which is stated on the carton and blister
labels after ‘Exp’. The expiry date refers to
the last day of that month.
If the tablets become discoloured or show
any signs of deterioration, seek the advice of
your pharmacist.
Remember if your doctor tells you to stop
taking this medicine, return any unused
medicine to your pharmacist for safe
disposal. Only keep this medicine if your
doctor tells you to.
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 Alfuzosin hydrochloride
contains
The active substance is 2.5mg alfuzosin
hydrochloride.
Alfuzosin hydrochloride also contain lactose,
microcrystalline cellulose, povidone, sodium
starch glycollate, magnesium stearate,
hypromellose, macrogol 400 and titanium
dioxide (E171).

What Alfuzosin hydrochloride looks
like and contents of the pack
Alfuzosin hydrochloride are white, round,
film-coated tablets marked ‘ALZ’ on one side
and ‘2.5’ on the reverse.
They are available in packs of 30.

Manufactured by: Sanofi-Winthrop
Industrie, 30-36 Avenue Gustave Eiffel,
Tours, France.

Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Alfuzosin hydrochloride 2.5mg Tablets;
PL 18799/1345
POM
Leaflet date: 25.05.2017

Blind or partially
sighted ?
Is this leaflet hard to
see or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

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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