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FUZATAL XL 10MG PROLONGED RELEASE TABLETS

Active substance(s): ALFUZOSIN HYDROCHLORIDE

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TEVA UK Ref:

231-30-65305-B LEA ALFUZOSIN (FUZATAL) 10MG TAB TUK

Version:

1

25 January 2016

PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 349

(Main)

pressure. You should discuss with your
doctor whether to continue or stop your
treatment with Fuzatal® XL, especially
when the chest pain recurs or worsens
PACKAGE LEAFLET:
- if you have an abnormal heart rhythm
INFORMATION FOR THE PATIENT
called QTc prolongation (long QT) or you
Read all of this leaflet carefully before you
are taking medicines likely to increase the
start taking this medicine.
risk of QTc prolongation. Tell your doctor if
- Keep this leaflet. You may need to read it
you suffer from this condition or are
again.
taking any other medicines.
- If you have any further questions, ask your - if you are over 65. This is due to the
doctor or pharmacist.
increased risk of developing low blood
- This medicine has been prescribed for
pressure (hypotension) and related side
you. Do not pass it on to others. It may
effects in elderly patients.
harm them, even if their symptoms are
- if you are undergoing eye surgery
the same as yours.
because of cataract (cloudiness of the
- If any of the side effects gets serious, or if
lens) please inform your eye specialist
you notice any side effects not listed in
before the operation that you are using or
this leaflet, please tell your doctor or
have previously used Fuzatal® XL. This is
pharmacist.
because Fuzatal® XL may cause
complications during the surgery which
What is in this leaflet :
can be managed if your specialist is
®
1. What Fuzatal XL is and what it is used for
prepared in advance.
2. What you need to know before you take
®
Fuzatal XL
Other medicines and Fuzatal® XL
3. How to take Fuzatal® XL
Tell your doctor or pharmacist if you are
4. Possible side effects
taking,have recently taken or might take any
5. How to store Fuzatal® XL
other medicine, including medicines
6. Contents of pack and other information
obtained without a prescription.

1

WHAT FUZATAL® XL IS AND WHAT Fuzatal® XL and some medicines may
interfere with each other. These include:
IT IS USED FOR

This drug belongs to the group of medicines - other medicines that belong to the group
of alpha-blockers: you must not take such
called alpha-blockers.
medicines at the same time as Fuzatal® XL
(see “Do not take Fuzatal® XL” above)
It is used to treat moderate to severe
- ketoconazole and itraconazole (medicines
symptoms caused by an enlarged prostate
used to treat fungal infections) and
gland, a condition that is also called benign
ritonavir (medicine used to treat HIV
prostatic hyperplasia. Enlarged prostate
glands can cause urinary problems such as - certain antibiotic drugs (clarithromycin,
erythromycin)
frequent and difficult urination.
- medicines you receive before an
operation (general anaesthetics). Your
2 WHAT YOU NEED TO KNOW ®
BEFORE YOU TAKE FUZATAL XL
blood pressure can drop markedly. If you
have to undergo an operation, please tell
Do not take Fuzatal® XL:
the doctor that you are taking Fuzatal® XL.
- if you are allergic to alfuzosin, other
quinazoline (e.g. terazosin, doxazosin) or
Fuzatal® XL with food and drink
any of the other ingredients of this
The tablet should be taken immediately
medicine (listed in section 6).
after the same meal each day.
- if you suffer from conditions that cause a
Pregnancy and breast-feeding
marked drop in blood pressure when
Fuzatal® XL is only intended for men.
standing up
- if you have hepatic impairment (liver
Driving and using machines
function disorder)
At the beginning, treatment with Fuzatal® XL
- if you are taking other medicines
may
make you feel light-headed, dizzy or
belonging to the group called
weak.
Do not drive or operate machinery or
alpha1-blockers (e.g. tamsulosin).
perform any hazardous tasks until you know
how your body responds to the treatment.
Warnings and precautions
Talk to your doctor or pharmacist before
Important information about some of the
taking Fuzatal® XL
ingredients of Fuzatal® XL
- if you have severe kidney problems
This medicine contains lactose. If you have
- if you take other medicines to treat high
been told by your doctor that you have an
blood pressure. In this case your doctor
intolerance to some sugars, contact your
will check your blood pressure regularly,
doctor before taking this medicinal product.
especially at the beginning of treatment
®
- if you experience a sudden drop in blood
3 HOW TO TAKE FUZATAL XL
pressure when you stand up shown by
dizziness, weakness or sweating within a
Always take this medicine exactly as your
few hours after you have taken Fuzatal® XL. doctor or pharmacist has told you. Check
If you experience a drop in blood pressure with your doctor or pharmacist if you are
you should lie down with your legs and
not sure.
feet up in the air until the symptoms have
disappeared. Usually, these effects last for Posology
only a short time and occur at the start of The recommended dose is 1 prolongedthe treatment. Normally, there is no need release tablet once daily. Take the first tablet
at bedtime. Take the tablets immediately after
to stop treatment
- if you experience a marked drop in blood the same meal each day and swallow them
whole with a sufficient amount of fluid. Do
pressure in the past after taking another
not crush, chew or divide the tablets.
medicine belonging to the group of
alpha-blockers. In this case your doctor
The posology does not need to be adjusted
will start treatment with alfuzosin at low
for elderly (over 65 years).
doses and will gradually increase the dose
The usual dose for patients with mild to
- if you suffer from acute heart failure
- if you suffer from chest pain (angina) and moderate kidney problems is 1 prolongedrelease tablet (10 mg alfuzosin). Take the first
are treated with a nitrate as this may
tablet at bedtime.
increase the risk of a drop in blood

Top of page cut-off to middle of registration mark: 44 mm.

Fuzatal® XL 10mg
prolonged release tablets
alfuzosin hydrochloride

TEVA UK Ref:

231-30-65305-B LEA ALFUZOSIN (FUZATAL) 10MG TAB TUK

Version:

1

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Fuzatal® XL, prolonged release tablets are
- Liver problems: signs may include
not intended for use in children or teenagers
yellowing of your skin or the whites of
aged 2 to 16 years as they have not been
your eyes;
shown to be effective in these patients.
- Abnormal, often painful, persistent
erection of the penis unrelated to sexual
If you take more Fuzatal® XL than you should:
activity (priapism).
If you take large amounts of Fuzatal® XL your
blood pressure may suddenly drop and you Reporting of side effects
may feel dizzy or even faint. If you begin to If you get any side effects, talk to your
doctor or pharmacist. This includes any
feel dizzy, sit or lie down until you feel
possible side effects not listed in this leaflet.
better. If the symptoms do not disappear,
You can also report side effects directly via
call your doctor as the drop in blood
pressure may have to be treated in hospital. the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
If you forget to take Fuzatal® XL, prolonged By reporting side effects you can help
release tablets:
provide more information on the safety of
Do not take a double dose to make up for a this medicine.
forgotten tablet as this may cause a sudden
®
drop in blood pressure, especially if you
5 HOW TO STORE FUZATAL XL
take blood-pressure lowering medicines.
Keep out of the sight and reach of children.
Take the next tablet as directed.
Do not use this medicine after the expiry
If you stop taking Fuzatal® XL, prolonged
date which is stated on the carton or blister
release tablets
strips after EXP. The expiry date refers to the
You should not interrupt or stop taking
last day of that month.
®
Fuzatal XL without speaking to your doctor Keep the blister in the outer carton in order
first. If you want to stop the treatment or
to protect from light.
have any further questions on the use of this Store below 30°C.
product, ask your doctor or pharmacist.
For bottles (HDPE):
The shelf life of the product after first
4 POSSIBLE SIDE EFFECTS
opening is 1 year, but no longer than the
Like all medicines, this medicine can cause expiry date stated on the box or bottle after
side effects, although not everybody gets
the letters EXP.
them.
Do not throw away any medicines via
Common (may affect up to 1 in 10 people):
wastewater or household waste. Ask your
- Dizziness/faintness, headaches
pharmacist how to throw away medicines
- Digestive disorders such as nausea,
you no longer use. These measures will help
stomach pain, dry mouth
protect the environment.
- Feeling of weakness, malaise.
Uncommon (may affect up to 1 in 100
people):
- Drowsiness, fainting, vertigo
- Visual disturbances
- Faster heartbeat, palpitations (the heart
beats more rapidly than normal and it is
also noticeable)
- Fall in blood pressure when moving from
a supine to a standing position (especially
when starting treatment with a too high
dose and when treatment is resumed)
- Flushing
- Rhinitis
- Diarrhoea
- Skin disorders such as skin rash or itching,
pruritus
- Redness of the face, oedema, chest pains.

6

CONTENTS OF PACK AND OTHER
INFORMATION

What Fuzatal® contains
The active substance is alfuzosin
hydrochloride. One prolonged release tablet
contains 10 mg of alfuzosin hydrochloride.
The other ingredients are lactose
monohydrate, hypromellose (E464),
povidone K25 and magnesium stearate.

What Fuzatal® XL looks like and contents of
the pack
Fuzatal® XL is a round white prolonged
release tablet in blister strips
(PVC/PVDC/aluminium) of 10, 28, 30, 50, 90
or 100 tablets per pack, or bottles (HDPE) of
100 tablets per pack.
Very rare (may affect up to 1 in 10,000 people): All pack sizes may not be marketed
- Worsening or recurrence of chest pain
Marketing Authorisation Holder and
(angina pectoris)
Manufacturer
- Quincke’s oedema (swelling of the face,
Marketing Authorisation Holder
lips, tongue and/or throat), urticaria.
Teva UK Ltd., Brampton Road, Hampden
Not known (frequency cannot be estimated Park, Eastbourne, East Sussex, BN22 9AG.
from the available data):
Manufacturer
- Reduced number of white blood cells
Company responsible for manufacture:
(neutropenia), which may lead to more
TEVA UK Limited, Eastbourne, BN22 9AG
frequent infections than usual;
- Intraoperative Floppy Iris Syndrome (IFIS). Product Licence number:
If you are undergoing eye surgery
because of cataract (cloudiness of the
PL 00289/1074
lens) and are using or have previously
used alfuzosin, the pupil may dilate poorly This leaflet was last revised in September
2015
and the iris (the coloured circular part of
the eye) may become floppy during the
procedure. This only occurs during the
operation and it is important for the eye
specialist to be aware of this possibility as
the operation may need to be performed
differently (see ‘Warnings and
precautions’ above);
- Abnormal heart rhythm (atrial fibrillation);
- Being sick (vomiting);
65305-B

160 x 323

25 January 2016

TEVA UK Ref:

Version:

231-30-86347-ZA LEA ALFUZOSIN (FUZATAL) 10MG TAB TUK
Fuzatal® XL 10mg
prolonged release tablets
alfuzosin hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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.

What is in this leaflet :
1. What Fuzatal® XL is and what it is used for
2. What you need to know before you take
Fuzatal® XL
3. How to take Fuzatal® XL
4. Possible side effects
5. How to store Fuzatal® XL
6. Contents of pack and other information

1

WHAT FUZATAL® XL IS AND WHAT IT IS
USED FOR

This drug belongs to the group of medicines called
alpha-blockers.
It is used to treat moderate to severe symptoms
caused by an enlarged prostate gland, a condition
that is also called benign prostatic hyperplasia.
Enlarged prostate glands can cause urinary
problems such as frequent and difficult urination.

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE FUZATAL® XL

Do not take Fuzatal® XL:
• if you are allergic to alfuzosin, other quinazoline
(e.g. terazosin, doxazosin) or any of the other
ingredients of this medicine (listed in section 6).
• if you suffer from conditions that cause a marked
drop in blood pressure when standing up
• if you have hepatic impairment (liver function
disorder)
• if you are taking other medicines belonging to the
group called alpha1-blockers (e.g. tamsulosin).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Fuzatal® XL
• if you have severe kidney problems
• if you take other medicines to treat high blood
pressure. In this case your doctor will check your
blood pressure regularly, especially at the
beginning of treatment
• if you experience a sudden drop in blood pressure
when you stand up shown by dizziness, weakness
or sweating within a few hours after you have
taken Fuzatal® XL. If you experience a drop in
blood pressure you should lie down with your legs
and feet up in the air until the symptoms have
disappeared. Usually, these effects last for only a
short time and occur at the start of the treatment.
Normally, there is no need to stop treatment
• if you experience a marked drop in blood
pressure in the past after taking another medicine
belonging to the group of alpha-blockers. In this
case your doctor will start treatment with
alfuzosin at low doses and will gradually increase
the dose

• if you suffer from acute heart failure
• if you suffer from chest pain (angina) and are
treated with a nitrate as this may increase the risk
of a drop in blood pressure. You should discuss
with your doctor whether to continue or stop your
treatment with Fuzatal® XL, especially when the
chest pain recurs or worsens
• if you have an abnormal heart rhythm called QTc
prolongation (long QT) or you are taking
medicines likely to increase the risk of QTc
prolongation. Tell your doctor if you suffer from
this condition or are taking any other medicines.
• if you are over 65. This is due to the increased risk
of developing low blood pressure (hypotension)
and related side effects in elderly patients.
• if you are undergoing eye surgery because of
cataract (cloudiness of the lens) please inform
your eye specialist before the operation that you
are using or have previously used Fuzatal® XL.
This is because Fuzatal® XL may cause
complications during the surgery which can be
managed if your specialist is prepared in advance.
Other medicines and Fuzatal® XL
Tell your doctor or pharmacist if you are taking ,have
recently taken or might take any other medicine,
including medicines obtained without a prescription.
Fuzatal® XL and some medicines may interfere with
each other. These include:
• other medicines that belong to the group of
alpha-blockers: you must not take such medicines
at the same time as Fuzatal® XL (see “Do not take
Fuzatal® XL” above)
• ketoconazole and itraconazole (medicines used to
treat fungal infections) and ritonavir (medicine
used to treat HIV
• certain antibiotic drugs (clarithromycin,
erythromycin)
• medicines you receive before an operation
(general anaesthetics). Your blood pressure can
drop markedly. If you have to undergo an
operation, please tell the doctor that you are
taking Fuzatal® XL.
Fuzatal® XL with food and drink
The tablet should be taken immediately after the
same meal each day.
Pregnancy and breast-feeding
Fuzatal® XL is only intended for men.
Driving and using machines
At the beginning, treatment with Fuzatal® XL may
make you feel light-headed, dizzy or weak. Do not
drive or operate machinery or perform any
hazardous tasks until you know how your body
responds to the treatment.
Important information about some of the
ingredients of Fuzatal® XL
This medicine contains lactose. 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 FUZATAL® XL

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Posology
The recommended dose is 1 prolonged-release
tablet once daily. Take the first tablet at bedtime.
Take the tablets immediately after the same meal
each day and swallow them whole with a sufficient
amount of fluid. Do not crush, chew or divide the
tablets.

5

16 September 2015

TEVA UK Ref:

Version:

231-30-86347-ZA LEA ALFUZOSIN (FUZATAL) 10MG TAB TUK
The posology does not need to be adjusted for
elderly (over 65 years).
The usual dose for patients with mild to moderate
kidney problems is 1 prolonged-release tablet (10 mg
alfuzosin). Take the first tablet at bedtime.
Fuzatal® XL, prolonged release tablets are not
intended for use in children or teenagers aged 2 to
16 years as they have not been shown to be
effective in these patients.
If you take more Fuzatal® XL than you should :
If you take large amounts of Fuzatal® XL your blood
pressure may suddenly drop and you may feel dizzy
or even faint. If you begin to feel dizzy, sit or lie
down until you feel better. If the symptoms do not
disappear, call your doctor as the drop in blood
pressure may have to be treated in hospital.
If you forget to take Fuzatal® XL, prolonged release
tablets:
Do not take a double dose to make up for a
forgotten tablet as this may cause a sudden drop in
blood pressure, especially if you take
blood-pressure lowering medicines. Take the next
tablet as directed.
If you stop taking Fuzatal® XL, prolonged release
tablets
You should not interrupt or stop taking Fuzatal® XL
without speaking to your doctor first. If you want to
stop the treatment or have any further questions on
the use of this product, ask your doctor or
pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Common (may affect 1 to 10 people):
• Dizziness/faintness, headaches
• Digestive disorders such as nausea, stomach
pain, dry mouth
• Feeling of weakness, malaise.
Uncommon (may affect up to 1 to 100 people):
• Drowsiness, fainting, vertigo
• Visual disturbances
• Faster heartbeat, palpitations (the heart beats
more rapidly than normal and it is also
noticeable)
• Fall in blood pressure when moving from a
supine to a standing position (especially when
starting treatment with a too high dose and when
treatment is resumed)
• Flushing
• Rhinitis
• Diarrhoea
• Skin disorders such as skin rash or itching,
pruritus
• Redness of the face, oedema, chest pains.
Very rare (may affect up to 1 in 10,000 people):
• Worsening or recurrence of chest pain (angina
pectoris)
• Quincke’s oedema (swelling of the face, lips,
tongue and/or throat), urticaria.
Not known (frequency cannot be estimated from
the available data):
• Reduced number of white blood cells
(neutropenia), which may lead to more frequent
infections than usual;
• Intraoperative Floppy Iris Syndrome (IFIS). If you
are undergoing eye surgery because of cataract
(cloudiness of the lens) and are using or have
previously used alfuzosin, the pupil may dilate
poorly and the iris (the coloured circular part of

5

the eye) may become floppy during the
procedure. This only occurs during the operation
and it is important for the eye specialist to be
aware of this possibility as the operation may
need to be performed differently (see ‘Warnings
and precautions’ above);
• Abnormal heart rhythm (atrial fibrillation);
• Being sick (vomiting);
• Liver problems: signs may include yellowing of
your skin or the whites of your eyes;
• Abnormal, often painful, persistent erection of the
penis unrelated to sexual activity (priapism).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 FUZATAL® XL

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the carton or blister strips after EXP. The
expiry date refers to the last day of that month.
Keep the blister in the outer carton in order to
protect from light.
Store below 30°C.
For bottles (HDPE):
The shelf life of the product after first opening is 1
year, but no longer than the expiry date stated on
the box or bottle after the letters EXP.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6

CONTENTS OF PACK AND OTHER
INFORMATION

What Fuzatal® contains
The active substance is alfuzosin hydrochloride. One
prolonged release tablet contains 10 mg of alfuzosin
hydrochloride.
The other ingredients are lactose monohydrate,
hypromellose (E464), povidone K25 and magnesium
stearate.
What Fuzatal® XL looks like and contents of the
pack
Fuzatal® XL is a round white prolonged release
tablet in blister strips (PVC/PVDC/aluminium) of 10,
28, 30, 50, 90 or 100 tablets per pack, or bottles
(HDPE) of 100 tablets per pack.
All pack sizes may not be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Ltd., Brampton Road, Hampden Park,
Eastbourne, East Sussex, BN22 9AG.
Manufacturer
Company responsible for manufacture: Merckle GmbH
Ludwig-Merckle Str. 3
89143 Blaubeuren/Germany
Product Licence number:
PL 00289/1074
This leaflet was last revised in September 2015

86347-ZA

16 September 2015

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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