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DAZULAR XL 10 MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dazular XL Tablets 10mg
Alfuzosin hydrochloride
Please Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor or your pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1 What Dazular XL Tablets 10 mg is and what
it is used for
2 What you need to know before you take
Dazular XL Tablets 10 mg
3 How to take Dazular XL Tablets 10 mg

1

What Dazular XL Tablets 10 mg
is and what it is used for
used for

Dazular XL Tablets 10 mg belongs to a group of
medicines called alpha-adrenoreceptor antagonists or
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, especially at night. Alpha-blockers relax
the muscles in the prostate and bladder neck. This
allows urine to flow out of the bladder more easily.

2

What you need to know before you
take Dazular XL Tablets 10 mg

Do not take Dazular XL Tablets 10 mg
• If you are allergic (hypersensitive) to alfuzosin, other
quinazolines (e.g. terazosin, doxazosin, prazosin) or
any of the other ingredients of Dazular XL Tablets
10 mg.
• If you suffer from conditions that cause a marked
drop in blood pressure when standing up.
• If you have liver problems.
• If you take other medicines that belong to the group
of alpha-blockers.
Warnings and precautions
• If you have severe kidney problems, since the
safety of Dazular XL Tablets 10 mg has not been
established in these patients.
• If you take medicines to treat high blood pressure.
In this case your doctor will check your blood
pressure regularly, especially at the beginning of
treatment. Normally, there is no need to stop
treatment.
• If you experienced a marked drop in blood pressure or
a hypersensitivity (allergic) reaction in the past after
taking another medicine belonging to the group of
alpha-blockers. In this case your doctor will start
treatment with Dazular 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.Your doctor will decide whether to treat
your angina with a nitrate medicine or stop treatment
with Dazular XL Tablets 10 mg, if your angina returns
or gets worse.
• 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 Dazular XL Tablets
10 mg. This is because Dazular XL Tablets 10 mg
may cause complications during the surgery which
can be managed if your specialist is prepared in
advance.

4
5

How to store Dazular XL Tablets 10 mg

6



Possible side effects

Contents of the pack and other information

If you suffer from a heart beat abnormality known as
"prolonged QT-interval".

Swallow the tablets whole. Do not crush, powder or chew
the tablets as too much of the active substance alfuzosin
may reach your body too quickly. This may raise the risk
of unwanted effects.
Children and adolescents
Dazular XL Tablets 10 mg is not indicated for use in
children and adolescent.
Other medicines and Dazular XL Tablets 10 mg
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Dazular XL Tablets 10 mg must not be taken if you take
other medicines that belong to the group of alphablockers.
Dazular XL Tablets 10 mg and some medicines may
interfere with each other. These include:
• medicines containing ketoconazole or itraconazole
(medicines used to treat fungal infections) or
ritonavir (medicine used to treat HIV).
• medicines to lower blood pressure.
• medicines (nitrates) used to treat the symptoms of
chest pain (angina). Please note that taking
Dazular XL Tablets 10 mg together with medicines
used to treat high blood pressure and nitrates used
e.g. to treat cardiac diseases may lead to low blood
pressure.
• 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 Dazular
XL Tablets 10 mg.
• medicines that are known to increase the
QT-interval.
Dazular XL Tablets 10 mg with food and drink
Dazular XL Tablets 10 mg should be taken after a meal.
Pregnancy and breast-feeding
This information is not relevant as Dazular XL Tablets 10
mg is only for men.
Driving and using machines
At the beginning of treatment with Dazular XL Tablets 10
mg you may 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.
Dazular XL Tablets 10 mg contains a small amount
of 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.

continued....

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3

How to take Dazular XL Tablets
10 mg

Always take Dazular XL Tablets 10 mg exactly as your
doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The recommended dose for adults, the elderly (over 65
years) and those with mild or moderate kidney problems
is 1 Dazular XL Tablets 10 mg once daily. Take the first
tablet at bed time. 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.
If you take more Dazular XL Tablets 10 mg than you
should
If you take large amounts of Dazular XL Tablets 10 mg
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 Dazular XL Tablets 10 mg
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 Dazular XL Tablets 10 mg
You should not interrupt or stop taking Dazular XL
Tablets 10 mg 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, Dazular XL Tablets 10 mg can cause
side effects, although not everybody gets them.
You should see your doctor immediately if you
experience any of the following symptoms:
• Swollen face, tongue or throat
• Difficulty in swallowing
• Difficulty in breathing and hives
The above symptoms are symptoms of angioedema,
which is a very rare side effect (may affect up to 1 in
10,000 people).
Other side effects that can occur with Dazular XL
Tablets 10 mg are:
Common (may affect up to 1 in 10 people):
Faintness/dizziness, headache, stomach pain, feeling
sick (nausea), feeling of weakness,
Uncommon (may affect up to 1 in 100 people):
Feeling drowsy, a spinning sensation in the head
(vertigo), loss of consciousness resulting from
insufficient blood flow to the brain, faster heartbeat,
marked drop in blood pressure when standing up
(especially when starting treatment with too high a dose
and when treatment is resumed), runny nose, diarrhoea,
skin rash, itching, swelling of ankles and feet, reddening
of the face (flushing), chest pain.
Very rare (may affect up to 1 in 10,000 people):
Angina pectoris in patients with known coronary heart
disease, hives, angioedema.

erection (priapism), decrease in white blood cells.
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 Dazular XL Tablets
10 mg

Do not store above 30 °C.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the blister and carton. The expiry date refers
to the last day of that month.
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 the pack and other
information

What Dazular XL Tablets 10 mg contains
The active substance is alfuzosin hydrochloride.
One prolonged-release tablet contains 10 mg alfuzosin
hydrochloride.
The other ingredients are: lactose monohydrate,
hypromellose (E 464), povidone K25, magnesium
stearate (E 470 b).
What Dazular XL Tablets 10 mg looks like and
contents of the pack
Dazular XL Tablets 10 mg are white, round, bevellededged, uncoated tablets.
Dazular XL Tablets 10 mg is available in blister packs
with 10, 20, 30, 50, 60, 60x1, 90, 100 and 180
prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Ltd.,
3 Howard Road, Eaton Socon
St.Neots, Cambridgeshire PE19 8ET
United Kingdom
Manufacturers:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
HEXAL A/S
Kanalholmen 8-12
2650 Hvidovre
Denmark
Tillomed Laboratories Ltd.
3 Howard Road, Eaton Socon
St Neots. Cambridgeshire, PE19 8ET
United Kingdom
PL 11311/0310
This leaflet was last revised in 16 November 2012

Not known (frequency cannot be estimated from the
available data):
If you must undergo eye surgery because of a cataract
and are taking Dazular XL Tablets 10 mg or have taken
it in the past, difficulties during surgery may occur (see
"Take special care with Dazular XL Tablets 10 mg").
Very rapid uncoordinated contractions of the heart,
vomiting, liver damage, persistent and painful penile

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for help
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Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Dazular XL
10 mg Tablets
PIL
165 x 297 mm
Font SansSerif − Min. Text 8pt
Till−Ver.1s
27/11/12
Pantone Black CVC

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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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