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XATRAL XL 10 MG PROLONGED RELEASE TABLETS

Active substance(s): ALFUZOSIN HYDROCHLORIDE

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Xatral® XL 10mg
prolonged release tablets

2361
15.09.15[7]

(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.
Your medicine is available using 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.
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.
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
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).
- You are over 65. This is due to the increased sensitivity to develop
hypotension and related adverse reactions in elderly patients.
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.
Do not take Xatral XL if you are taking:
- Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin,
tamsulosin, or phenoxybenzamine.

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 alpha-blockers).
- 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.
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 (34 days in total).
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.
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.
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.
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.
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.
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.
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).
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 XATRAL XL
Keep out of the sight and reach of children.
Do not use Xatral XL after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
If your doctor tells you to stop taking the tablets, please take them back to
your pharmacist for safe disposal.
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.

If your tablets become discoloured show any visible signs of deterioration,
consult your pharmacist who will advise you what to do.
6. FURTHER INFORMATION
What Xatral XL contains
The active substance is 10 mg alfuzosin hydrochloride.
- The other ingredients are ethyl cellulose, hydrogenated castor oil,
hypromellose, yellow iron oxide (E172), magnesium stearate,
microcrystalline cellulose, povidone K30, silicon dioxide hydrated and
mannitol.
What Xatral XL looks like and contents of the pack
Xatral XL are round biconvex, three layer tablets: one white layer between
two yellow layers.
Available in blister packs of 30, 50, 60 and 100 tablets.
Manufacturer and Product Licence Holder
Manufactured by Sanofi Winthrop Industrie, 20 Avenue Raymond Aron,
92160 Antony, France and is Procured from within the EU by the Product
Licence holder Tenolol Ltd.,5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 30900/2361

Leaflet revision and issue date (Ref) 15.09.15[7]
Xatral is a trademark of Sanofi-Aventis.

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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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