BESAVAR XL 10 MG TABLETS

Active substance: ALFUZOSIN HYDROCHLORIDE

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Additional side effects (frequency
not known) which may occur are:
• Abnormal liver function (liver
problem). Signs may include
yellowing of your skin or the whites
of your eyes
• Occasionally problems have arisen
during cataract surgery in patients
taking alfuzosin. If you are due to
have eye surgery because of
cataracts it is important that you tell
the specialist before the operation
that you are using, or have used,
Besavar XL.
• A painful erection of the penis,
unrelated to sexual activity, that will
not go away.
• 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).
• Increased risk of bleeding (including
nose bleeds and/or bleeding gums) and
bruising. This could be a problem called
‘thrombocytopenia’ which is a reduced
number of platelets in the blood.

hydrogenated castor oil, hypromellose,
yellow ferric oxide (E172), magnesium
stearate, microcrystalline cellulose,
povidone, colloidal hydrated silica and
mannitol.
What Besavar XL looks like and
contents of the pack
Besavar XL 10mg Tablets are round,
biconvex, three layer tablets: one white
layer between two yellow layers. They are
supplied in blister packs of 30 tablets.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder is:
Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Manufacturer is:
Fawdon Manufacturing Centre,
Edgefield Avenue, Fawdon,
Newcastle-upon-Tyne, NE3 3TT,
United Kingdom
This leaflet was last revised in:
September 2012
© 2012 Zentiva

5. How to store Besavar XL

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.
In this leaflet:
1. What Besavar XL is and what it is
used for
2. Before you take Besavar XL
3. How to take Besavar XL
4. Possible side effects
5. How to store Besavar XL
6. Further information

1. What Besavar XL is and what it
is used for

• Keep this medicine in a safe place
where children cannot see or reach it.
• Store in the original packaging.
• Do not use Besavar XL after the expiry
date which is stated on the carton.
• 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.

The name of your medicine is Besavar XL
10mg Tablets (called Besavar XL
throughout this leaflet). Besavar XL
contains a medicine called alfuzosin
hydrochloride. This belongs to a group of
medicines called alpha-blockers.

6. Further information
What Besavar XL 10mg Tablets contain
Each tablet contains 10mg of alfuzosin
hydrochloride as the active substance.
The other ingredients are, ethyl cellulose,

BESAVAR XL 10MG
TABLETS

30209806
4

Besavar XL 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.
In a few patients with benign prostatic
hyperplasia, the prostate gland gets so
big that it stops the flow of urine
completely. This is called Acute Urinary
Retention. This is very painful and you
may need a short stay in hospital.
• A thin, flexible tube (catheter) is
passed into the bladder. This drains
the water and relieves the pain.
• During this time, Besavar XL may be
used to help the water to flow again.
This has only been shown to help in
men aged over 65.

2. Before you take Besavar XL
Do not take Besavar XL and tell your
doctor if:
• You are allergic (hypersensitive) to
alfuzosin hydrochloride or any of the
other ingredients of this medicine
(listed in Section 6 below)
Signs of an allergic reaction include: a
rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
• You are taking other alpha-blockers to
treat Benign Prostatic Hypertrophy or
possibly to lower your blood pressure.
See section below on ‘Taking other
medicines’.
• You have, or have ever had, something
called orthostatic hypotension. This is a
drop in blood pressure which usually
happens when you stand up. It can
make you feel dizzy, light-headed or
faint when you stand or sit up quickly
• You have liver problems

1

Take special care and check with your
doctor before taking Besavar XL if:
• You have chest pain (angina)
• You have a condition where your
kidneys are hardly working at all
• You have kidney problems
• 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 Besavar XL.
This is because Besavar XL may
cause complications during the surgery
which can be managed if your
specialist is prepared in advance
• You are allergic (hypersensitive) to
other alpha blockers such as
doxazosin, tamsulosin
• You are taking medicines for high
blood pressure. Your doctor should
monitor your blood pressure regularly
while you are taking this medicine. This
is particularly important at the start of
your treatment.
• 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)
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Besavar XL.
Taking Besavar XL with other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines. This includes medicines
you buy without a prescription, including
herbal medicines. This is because
Besavar XL and some other medicines
can affect the way each other work.
Do not take this medicine, and tell
your doctor, if you are taking:
• Other alpha-blockers such as
doxazosin, indoramin, prazosin,
terazosin, tamsulosin, or
phenoxybenzamine.

Tell your doctor if you are taking
any of the following:
• 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.
• Medicines such as glyceryl trinitrate
for chest pain (angina)
• Medicines for fungal infections (such
as ketoconazole and itraconazole)
and HIV (ritonavir).
Operations and tests while taking
Besavar XL
• 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 Besavar XL
before the operation. Your doctor may
decide to stop you having Besavar XL
24 hours before the operation.
This is because it can be dangerous as it
can lower your blood pressure.
Taking Besavar XL with food and drink
• Take Besavar XL after a meal.
• You may feel dizzy and weak while
taking Besavar XL. If this happens do
not drink any alcohol.
Driving and using machines
You may feel dizzy and weak while taking
Besavar XL. If this happens do not drive
or operate any tools or machines.
Important information about some of
the ingredients of Besavar XL
• Hydrogenated castor oil: This can
cause stomach upset and diarrhoea.

3. How to take Besavar XL
Always take Besavar XL exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you are
not sure.
2

Taking this medicine
• Swallow the tablets whole with plenty
of water
• Do not break, crush or chew your
tablets. This can affect the release of
your medicine into the body.
• Take this medicine after a meal.
How much to take
Benign Prostatic Hyperplasia
• The usual dose is one Besavar XL
tablet once a day.
Acute Urinary Retention
• Besavar XL will be given to you by
your doctor on the day you have the
catheter inserted.
• You should continue taking Besavar
XL once a day.
• You should stop taking Besavar XL
the day after the catheter is
removed (3-4 days in total).
Children
Alfuzosin is not recommended for use
in children under 16 years of age.
If you take more Besavar XL than you
should
Contact your local hospital Accident and
Emergency department straight away. Tell
the doctor or nurse 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 Besavar XL
Do not take a double dose to make up for
a forgotten tablet. Miss it out and then go
on as before.
If you stop taking Besavar XL
Keep taking your tablets, even if your
symptoms improve. Only stop if your
doctor tells you to. The symptoms are
better controlled if you continue taking the
same dose of this medicine.
If you have any further questions about this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Besavar XL can cause
side effects, although not everybody gets
them.

Stop taking Besavar XL and see a doctor
or go to a hospital straight away if:
• You get swelling of the hands, feet,
ankles, face, lips or throat which may
cause difficulty in swallowing or
breathing. You could also notice an
itchy, lumpy rash (hives) or nettle rash
(urticaria). This may mean you are
having an allergic reaction to
Besavar XL tablets.
• You have chest pain (angina). This
usually only happens if you have had
angina before. This side effect is very
rare
• You have a painful erection of the
penis, not related to sexual activity,
which will not go away. This side effect
has only been reported in a very small
number of people taking Besavar XL.
Tell your doctor or pharmacist if any of
the following side effects get serious
or lasts longer than a few days. Also
tell them if you notice any side effects
not listed in this leaflet
Common side effects (affects less
than 1 in 10 people)
• Feeling dizzy or faint
• Headache
• Feeling sick (nausea)
• Stomach pain
• Weakness or tiredness
Uncommon side effects (affects less
than 1 in 100 people)
• Feeling dizzy light-headed or faint
when you stand or sit up quickly
(postural hypotension)
• A fast heart beat (tachycardia) and
pounding in the chest and uneven
heartbeat (palpitations)
• Chest pain
• Drowsiness
• Diarrhoea
• Dry mouth
• Rash and itching
• Flushes
• Water retention (may cause swollen
arms or legs)
• General feeling of being unwell
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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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