XATRAL XL 10MG TABLETS

Active substance: ALFUZOSIN HYDROCHLORIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

XATRAL® XL 10mg TABLETS
(alfuzosin hydrochloride)
Patient Information Leaflet

This product is known as the above name but will be referred to as Xatral XL throughout this leaflet.

In this leaflet:
1. What Xatral XL is and what it is used for
2. Before you take Xatral XL
3. How to take Xatral XL
4. Possible side effects
5. How to store Xatral XL
6. Further information
1. What Xatral XL is and what it is used for
The name of your tablets is Xatral XL. This belongs to a group of medicines called alpha-blockers.
Xatral XL can be used to treat the symptoms of Benign Prostatic Hyperplasia. 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.

WARNING!

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, Xatral XL may be used to help the water to flow again. This has only been
shown to help in men aged over 65.

DATE:

2. Before you take Xatral XL
Do not take Xatral XL if:
• You are allergic (hypersensitive) to alfuzosin or any of the other ingredients of Xatral XL (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 liver problems.
If you are not sure if any of these apply to you, do not take and talk to your doctor.

DATE:
30/04/13

Do not take Xatral XL if you are taking:
• Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin, or
phenoxybenzamine.

6464/1479D

TVT CHECKED

DATE OF PROOF:

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 XL can affect the way some other medicines work. Some medicines can also have
an effect on the way that Xatral XL works.

CODE:

DT
ARTWORKER:
PRODUCT:

Xatral XL 10mg Tabs

Q.A.
APPROVED:
05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Take special care with Xatral XL
Check with your doctor or pharmacist before taking your medicine if:
• You have chest pain (angina).
• You have a condition where your kidneys are hardly working at all.
• 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).

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 alphablockers).
• 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 high blood pressure (hypertension).
• 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 XL
• if you are going to have an operation on the eye because of cataract (cloudiness of the eye'), tell
your eye specialist you are using or have used Xatral XL in the past.
This is because Xatral XL may cause complications during your operation. This can be managed
if your eye specialist knows before carrying out the operation
• 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 XL before the operation. Your doctor may decide to stop you having Xatral XL 24
hours before the operation.
This is because it can be dangerous as it can lower your blood pressure.
Taking Xatral XL with food and drink
• Take Xatral XL after a meal.
• You may feel dizzy and weak while taking Xatral XL. If this happens do not drink any alcohol.
Driving and using machines
You may feel dizzy and weak while taking Xatral XL. If this happens do not drive or operate any tools or
machines.
Important information about some of the ingredients of Xatral XL
Xatral XL contains hydrogenated castor oil. This can cause stomach upset and diarrhoea.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 400
11/12

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 30/04/13

Notes:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

3. How to take Xatral XL
Always take Xatral XL 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.
Benign Prostatic Hyperplasia
The usual dose is one Xatral XL tablet once a day.
Acute Urinary Retention
• Xatral XL will be given to you by your doctor on the day you have the catheter inserted.
• You should continue taking Xatral XL once a day.
• You should stop taking Xatral XL the day after the catheter is removed (3-4 days in total).

If you stop taking Xatral 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 on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Xatral XL can cause side effects, although not everybody gets them.
These side effects are most likely to happen at the start of treatment.

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.

30/04/13
DATE OF PROOF:

DATE:

DT
ARTWORKER:

TVT CHECKED

05-0269

WARNING!

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 your skin or the whites of your eyes.
• If you are having an operation on your eyes because of cataracts (where the lens of the eye is
cloudy) and are already taking or have taken Xatral XL 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 out differently (see section 'Take special care with Xatral 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
• Increased risk of bleeding (including nose bleeds and/or bleeding gums) and bruising.
This could be a blood problem called 'thrombocytopenia' which is a reduced number of platelets in
the blood.

6464/1479D







CODE:

Xatral XL 10mg Tabs
PRODUCT:

CUSTOMER: Waymade

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 XL
Xatral XL 10mg Tablets should be stored in their original container.
Do not use after the expiry date printed on the carton or blister label. The expiry date refers to the
last day of that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking these tablets, please take them back to the pharmacist for
safe disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist.
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.

6. Further information
Your medicine is called Xatral XL 10mg tablets. Each tablet contains 10mg of the active ingredient
alfuzosin hydrochloride in a round cylindrical tablet with two pale yellow layers separated by a white layer
and has no markings on either side.
Xatral XL 10mg tablets are made in a ‘sustained release’ form. This means they release their active
ingredient slowly and therefore you only take the tablets once a day
Xatral XL 10mg tablets also contain the following:
Povidone, colloidal silica hydrated, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl
cellulose, hydrogenated castor oil, mannitol and yellow iron oxide (E172).
Xatral XL 10mg tablets are available in blister packs of 10 and 30 tablets.
POM

PL No: 6464/1479

This product is manufactured by Sanofi-Winthrop Industrie, Avenue Gustav Eiffel, Tours, France and is
procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 30.04.2013
Xatral is a registered trademark of Sanofi-aventis.

Colour
Swatch

Black

WARNING!

DATE:

Uncommon (affects less than 1 in 100 people)
• Feeling dizzy, lightheaded, or faint when you stand or sit up quickly (postural hypotension).
• Fast heart beat (tachycardia) and palpitations (pounding in the chest and uneven heartbeat).
• Chest pain.
• Drowsiness.
• Diarrhoea.
• Dry mouth.
• Rash and itching.
• Flushes.
• Water retention (may cause swollen arms or legs).
• Runny nose, itching, sneezing, and stuffy nose.
• General feeling of being unwell.
• Problems with your vision
Very rare side effects (affects less than 1 in 10,000 people)
• Itchy, lumpy rash also called hives or nettle rash (urticaria).

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 400
11/12

If you forget to take Xatral XL
Do not take a double dose to make up for a forgotten tablet. Miss it out and then go on as before.

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.

PROOF HISTORY:
v.1 - waymade - 30/04/13

Notes:

If you take more Xatral XL 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.

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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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