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BESAVAR XL 10 MG TABLETS

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

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PATIENT INFORMATION LEAFLET

BESAVAR XL 10MG
TABLETS
Alfuzosin hydrochloride

• 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
Read all of this leaflet carefully before you
start taking this medicine.
Do not take Besavar XL and tell your doctor if:
• Keep this leaflet. You may need to read it again.
• You are allergic (hypersensitive) to alfuzosin
• If you have any further questions, ask your
hydrochloride or any of the other ingredients of
doctor or pharmacist.
this medicine (listed in Section 6 below)
• This medicine has been prescribed for you. Do
Signs of an allergic reaction include: a rash,
not pass it on to others. It may harm them, even
swallowing or breathing problems, swelling of
if their symptoms are the same as yours.
your lips, face, throat or tongue
• If any of the side effects gets serious, or if you
• You are taking other alpha-blockers to treat
notice any side effects not listed in this leaflet,
Benign Prostatic Hypertrophy or possibly to
please tell your doctor or pharmacist.
lower your blood pressure. See section below
In this leaflet:
on ‘Taking other medicines’
1. What Besavar XL is and what it is used for
• You have, or have ever had, something called
2. Before you take Besavar XL
orthostatic hypotension. This is a drop in blood
3. How to take Besavar XL
pressure which usually happens when you
4. Possible side effects
stand up. It can make you feel dizzy, light5. How to store Besavar XL
headed or faint when you stand or sit up quickly
6. Further information
• You have liver problems
Take special care and check with your doctor
before taking Besavar XL if:
• You have chest pain (angina)
The name of your medicine is Besavar XL 10mg
• You have a condition where your kidneys are
Tablets (called Besavar XL throughout this leaflet).
hardly working at all
Besavar XL contains a medicine called alfuzosin
• You have kidney problems
hydrochloride. This belongs to a group of
• You are undergoing eye surgery because of
medicines called alpha-blockers.
cataract (cloudiness of the lens) please inform
your eye specialist before the operation that you
Besavar XL can be used to treat the symptoms of
are using or have previously used Besavar XL.
Benign Prostatic Hypertrophy. This is when the
This is because Besavar XL may cause
prostate gland enlarges (hyperplasia), but the
complications during the surgery which can be
growth is not cancerous (it is benign). It can
managed if your specialist is prepared in advance
cause problems in passing water (urine). This
• You are allergic (hypersensitive) to other alpha
happens mainly in older men.
blockers such as doxazosin, tamsulosin
• The prostate gland lies underneath the bladder.
• You are taking medicines for high blood
It surrounds the urethra. This is the tube that
pressure. Your doctor should monitor your
takes your water to the outside of the body.
blood pressure regularly while you are taking
• If the prostate gets bigger, it presses on the
this medicine. This is particularly important at
urethra making it smaller. This makes it difficult
the start of your treatment.
to pass water.
• Your tablets work by relaxing the prostate gland • You have heart problems, or if your heart
suddenly stopped pumping efficiently (acute
muscle. This allows the urethra to get bigger
cardiac failure)
and so makes it easier to pass water.
In a few patients with benign prostatic hyperplasia, • You have hereditary problems with the way
your heart beats (congenital QTc prolongation)
the prostate gland gets so big that it stops the
• You are over 65. This is due to the increased
flow of urine completely. This is called Acute
risk of developing hypotension and related
Urinary Retention. This is very painful and you
adverse reactions in elderly patients.
may need a short stay in hospital.
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1. What Besavar XL is and what it is
used for

• You ever get painful erections of the penis,
unrelated to sexual activity that will not go
away, before or during treatment.
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 (such
as 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.
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.
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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

• 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.
• 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.
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 Besavar XL

• 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
Uncommon side effects (affects less than 1 in
pharmacist how to dispose of medicines no
100 people)
longer required. These measures will help to
• Feeling dizzy light-headed or faint when you
protect the environment.
stand or sit up quickly (postural hypotension)
• A fast heart beat (tachycardia) and pounding in 6. Further information
the chest and uneven heartbeat (palpitations)
• Chest pain
What Besavar XL 10mg Tablets contain
• Drowsiness
Each tablet contains 10mg of alfuzosin
• Diarrhoea
hydrochloride as the active substance.
• Dry mouth
The other ingredients are ethyl cellulose,
• Rash and itching
hydrogenated castor oil, hypromellose, yellow
• Flushes
ferric oxide (E172), magnesium stearate,
• Water retention (may cause swollen arms or
microcrystalline cellulose, povidone, colloidal
legs)
hydrated silica and mannitol.
• General feeling of being unwell
What Besavar XL looks like and contents of
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.

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.
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Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder is:
Zentiva,
One Onslow Street,
Guildford,
Surrey,
GU1 4YS,
UK
Manufacturer is:
Sanofi Winthrop Industrie,
30-36 Avenue Gustave Eiffel,
37000 Tours,
France

*662261*

This leaflet was last revised in: May 2017
© 2017 Zentiva

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662261

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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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