XATRAL 2.5MG TABLETS

Active substance: ALFUZOSIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Ref:0265/110512/1/F

Xatral ® 2.5mg Tablets
(alfuzosin hydrochloride)
Patient Information 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.
Your medicine is called Xatral 2.5mg Tablets but will be referred to as Xatral
throughout this leaflet.
In this leaflet:
1 What Xatral is and what it is used for
2 Before you take Xatral
3 How to take Xatral
4 Possible side effects
5 How to store Xatral
6 Further information

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

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 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 Xatral
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 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)
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:
* 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 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

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 tablet three times a day.
If you are over 65 or are being treated for high blood pressure
* You should start on one Xatral tablet in the morning and one tablet in the
evening.
If you have kidney problems
* You should start on one Xatral tablet twice a day. This may be changed
depending upon how you respond.
If you have liver problems
* You should start on one Xatral tablet 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.
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.
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.

®

Ref:0265/110512/1/B

Xatral 2.5mg Tablets
(alfuzosin hydrochloride)
Patient Information Leaflet (continued)
4

Possible side effects

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.
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.
* 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.
* 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
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 the skin or whites of your
eyes
* Intraoperative Floppy Iris Syndrome (IFIS). If you are having an operation
on your eyes becuase 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 our 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
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.
5

How to store Xatral

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets
to your pharmacist (chemist) for safe disposal. Only keep his medicine, if
your doctor tells you to. If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist (chemist) who will tell
you what to do.

Storing your medicine
KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 30°C.
Store in the original package.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist (chemist). He/she will have
additional information about this medicine and will be able to advise you.

6

Further Information

What Xatral contains
Each tablet contains 2.5mg alfuzosin hydrochloride as the active ingredient.
Xatral also contains microcrystalline cellulose, lactose, povidone, sodium
starch glycollate, macrogol, magnesium stearate, titanium dioxide (E171),
hypromellose.
What Xatral looks like and contents of the pack
They are white round film coated tablets, marked Xatral 2.5 on one side and
plain on the other.
They are available in blister packs of 30, 60 & 90 tablets.
Manufacturer and Licence Holder:
Xatral is manufactured by Sanofi Winthrop Industrie, Tours, France and are
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
POM

PL Number: 15184/0265 Xatral 2.5mg Tablets

Xatral is a registered trademark of Sanofi-Synthelabo.
Revision date: 11/05/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref:0265/110512/2/F

Alfuzosin hydrochloride 2.5mg Tablets
Patient Information 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.
Your medicine is called Alfuzosin hydrochloride 2.5mg Tablets but will be
referred to as Alfuzosin hydrochloride throughout this leaflet.
In this leaflet:
1 What Alfuzosin hydrochloride is and what it is used for
2 Before you take Alfuzosin hydrochloride
3 How to take Alfuzosin hydrochloride
4 Possible side effects
5 How to store Alfuzosin hydrochloride
6 Further information

1

What Alfuzosin hydrochloride is and what it is used
for

The name of your tablets is Alfuzosin hydrochloride. This belongs to a group
of medicines called alpha-blockers.
Alfuzosin 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)
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 tablet three times a day.
If you are over 65 or are being treated for high blood pressure
* You should start on one Alfuzosin hydrochloride tablet in the morning and
one tablet in the evening.
If you have kidney problems
* You should start on one Alfuzosin hydrochloride tablet twice a day. This
may be changed depending upon how you respond.
If you have liver problems
* You should start on one Alfuzosin hydrochloride tablet a day. This may be
changed to two tablets a day, depending upon how you respond.
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
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.

Ref:0265/110512/2/B

Alfuzosin hydrochloride 2.5mg Tablets
Patient Information Leaflet (continued)
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

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.
* 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.
* 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
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 the skin or whites of your
eyes
* Intraoperative Floppy Iris Syndrome (IFIS). If you are having an operation
on your eyes becuase 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 our 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
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.

5

How to store Alfuzosin hydrochloride

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.

If your doctor tells you to stop taking this medicine, return any unused tablets
to your pharmacist (chemist) for safe disposal. Only keep his medicine, if
your doctor tells you to. If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist (chemist) who will tell
you what to do.
Storing your medicine
KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 30°C.
Store in the original package.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist (chemist). He/she will have
additional information about this medicine and will be able to advise you.

6

Further information

What Alfuzosin hydrochloride contains
Each tablet contains 2.5mg alfuzosin hydrochloride as the active ingredient.
Alfuzosin hydrochloride also contains microcrystalline cellulose, lactose,
povidone, sodium starch glycollate, macrogol, magnesium stearate, titanium
dioxide (E171), hypromellose.
What Alfuzosin hydrochloride looks like and contents of the pack
They are white round film coated tablets, marked Xatral 2.5 on one side and
plain on the other.
They are available in blister packs of 30, 60 & 90 tablets.
Manufacturer and Licence Holder:
Alfuzosin hydrochloride is manufactured by Sanofi Winthrop Industrie, Tours,
France and are procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
POM

PL Number: 15184/0265 Alfuzosin hydrochloride 2.5mg Tablets

Revision date: 11/05/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.
.

Ref:0265/110512/1/F

Xatral ® 2.5mg Tablets
(alfuzosin hydrochloride)
Patient Information 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.
Your medicine is called Xatral 2.5mg Tablets but will be referred to as Xatral
throughout this leaflet.
In this leaflet:
1 What Xatral is and what it is used for
2 Before you take Xatral
3 How to take Xatral
4 Possible side effects
5 How to store Xatral
6 Further information

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

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 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 Xatral
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 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)
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:
* 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 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

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 tablet three times a day.
If you are over 65 or are being treated for high blood pressure
* You should start on one Xatral tablet in the morning and one tablet in the
evening.
If you have kidney problems
* You should start on one Xatral tablet twice a day. This may be changed
depending upon how you respond.
If you have liver problems
* You should start on one Xatral tablet 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.
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.
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.

®

Ref:0265/110512/1/B

Xatral 2.5mg Tablets
(alfuzosin hydrochloride)
Patient Information Leaflet (continued)
4

Possible side effects

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.
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.
* 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.
* 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
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 the skin or whites of your
eyes
* Intraoperative Floppy Iris Syndrome (IFIS). If you are having an operation
on your eyes becuase 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 our 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
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.
5

How to store Xatral

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets
to your pharmacist (chemist) for safe disposal. Only keep his medicine, if
your doctor tells you to. If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist (chemist) who will tell
you what to do.

Storing your medicine
KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 30°C.
Store in the original package.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist (chemist). He/she will have
additional information about this medicine and will be able to advise you.

6

Further Information

What Xatral contains
Each tablet contains 2.5mg alfuzosin hydrochloride as the active ingredient.
Xatral also contains microcrystalline cellulose, lactose, povidone, sodium
starch glycollate, macrogol, magnesium stearate, titanium dioxide (E171),
hypromellose.
What Xatral looks like and contents of the pack
They are white round film coated tablets, marked Xatral 2.5 on one side and
plain on the other.
They are available in blister packs of 30, 60 & 90 tablets.
Manufacturer and Licence Holder:
Xatral is manufactured by Sanofi Winthrop Industrie, Tours, France and are
procured from within the EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
POM

PL Number: 15184/0265 Xatral 2.5mg Tablets

Xatral is a registered trademark of Sanofi-Synthelabo.
Revision date: 11/05/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref:0265/110512/2/F

Alfuzosin hydrochloride 2.5mg Tablets
Patient Information 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.
Your medicine is called Alfuzosin hydrochloride 2.5mg Tablets but will be
referred to as Alfuzosin hydrochloride throughout this leaflet.
In this leaflet:
1 What Alfuzosin hydrochloride is and what it is used for
2 Before you take Alfuzosin hydrochloride
3 How to take Alfuzosin hydrochloride
4 Possible side effects
5 How to store Alfuzosin hydrochloride
6 Further information

1

What Alfuzosin hydrochloride is and what it is used
for

The name of your tablets is Alfuzosin hydrochloride. This belongs to a group
of medicines called alpha-blockers.
Alfuzosin 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)
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 tablet three times a day.
If you are over 65 or are being treated for high blood pressure
* You should start on one Alfuzosin hydrochloride tablet in the morning and
one tablet in the evening.
If you have kidney problems
* You should start on one Alfuzosin hydrochloride tablet twice a day. This
may be changed depending upon how you respond.
If you have liver problems
* You should start on one Alfuzosin hydrochloride tablet a day. This may be
changed to two tablets a day, depending upon how you respond.
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
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.

Ref:0265/110512/2/B

Alfuzosin hydrochloride 2.5mg Tablets
Patient Information Leaflet (continued)
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

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.
* 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.
* 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
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 the skin or whites of your
eyes
* Intraoperative Floppy Iris Syndrome (IFIS). If you are having an operation
on your eyes becuase 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 our 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
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.

5

How to store Alfuzosin hydrochloride

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.

If your doctor tells you to stop taking this medicine, return any unused tablets
to your pharmacist (chemist) for safe disposal. Only keep his medicine, if
your doctor tells you to. If your tablets become discoloured or show any
other signs of deterioration, consult your pharmacist (chemist) who will tell
you what to do.
Storing your medicine
KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 30°C.
Store in the original package.
Important
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist (chemist). He/she will have
additional information about this medicine and will be able to advise you.

6

Further information

What Alfuzosin hydrochloride contains
Each tablet contains 2.5mg alfuzosin hydrochloride as the active ingredient.
Alfuzosin hydrochloride also contains microcrystalline cellulose, lactose,
povidone, sodium starch glycollate, macrogol, magnesium stearate, titanium
dioxide (E171), hypromellose.
What Alfuzosin hydrochloride looks like and contents of the pack
They are white round film coated tablets, marked Xatral 2.5 on one side and
plain on the other.
They are available in blister packs of 30, 60 & 90 tablets.
Manufacturer and Licence Holder:
Alfuzosin hydrochloride is manufactured by Sanofi Winthrop Industrie, Tours,
France and are procured from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
POM

PL Number: 15184/0265 Alfuzosin hydrochloride 2.5mg Tablets

Revision date: 11/05/12

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.
.

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.

Hide
(web3)