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XATRAL TABLETS 2.5MG

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S1439 LEAFLET Xatral 201205092



If you are going to have an operation on the eye called 'cataract
(cloudiness of the eye'), tell your eye specialist you are using or
have used Xatral in the past. This is because Xatral may cause
complications during your operation. This can be managed if
your eye specialist knows before carrying out the operation.

PACKAGE LEAFLET: INFORMATION FOR THE USER

XATRAL TABLETS 2.5mg
ALFUZOSIN HYDROCHLORIDE TABLETS 2.5mg
(alfuzosin hydrochloride)



The tablets may be called either of the names given above. They
will be referred to as Xatral in this leaflet.

You have circulatory problems affecting the brain as there is a
risk of impaired brain function due to low blood flow.



Read all of this leaflet carefully before you start taking this
medicine

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)



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



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

Taking other medicines



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.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines including medicines obtained
without a prescription.



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:

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

1. What Xatral is and what it is used for



Do not take Xatral if you are taking:

2. Before you take Xatral
3. How to take Xatral
4. Possible side effects
5. How to store Xatral

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.

6. Further information
1. WHAT XATRAL IS AND WHAT IT IS USED FOR
The name of your tablets is Xatral. This belongs to a group of
medicines called alpha-blockers.
Xatral 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.

Other alpha-blockers such as doxazosin, indoramin, prazosin,
terazosin, tamsulosin, or phenoxybenzamine.

Check with your doctor if you are taking any of the following:


Medicines for chest pain (angina)



Medicines for fungal infections (such as ketoconazole or
itraconazole) and HIV (such as ritonavir).



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.

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 before the
operation. Your doctor may decide to stop you having Xatral 24
hours before the operation. This is because it can be dangerous
as it can lower your blood pressure.

Operations and tests while taking Xatral

2. BEFORE YOU TAKE XATRAL
Do not take xatral if:
 You are allergic (hypersensitive) to alfuzosin or any of the other
ingredients of Xatral (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'.

Taking Xatral with food and drink


You may feel dizzy and weak while taking Xatral. If this
happens do not drink any alcohol.

Driving and using machines

 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 may feel dizzy and weak while taking Xatral. If this happens do
not drive or operate any tools or machines.

 You have serious liver problems.

Important information about some of the ingredients of Xatral

If you are not sure if any of these apply to you, do not take and talk
to your doctor

If you have been told by your doctor that you have an intolerance to
some sugars contact your doctor before taking this medicinal
product.

Take special care with Xatral
Check with your doctor or pharmacist before taking your medicine
if:
 You have chest pain (angina).
 You have a long-term infection in your urinary tract (including
your kidney, bladder and urethra), had difficulty when passing
water or had small crystals (stones) forming in the water.

3. HOW TO TAKE XATRAL
Always take Xatral 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.
The usual dose is one Xatral tablet three times a day.

If you are over 65 or are being treated for high blood pressure

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:

You should start on one Xatral tablet in the morning and one
tablet in the evening.

If you have kidney problems



You should start on one Xatral tablet twice a day. This may be
changed depending upon how you respond.
If you have liver problems

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.





Intraoperative Floppy Iris Syndrome (IFIS). 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 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').



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).



Abnormal heart rhythm.



Impaired brain function due to low blood flow in patients with
existing circulatory problems affecting the brain.



You should start on one Xatral tablet a day. This may be
changed to two tablets a day, depending upon how you
respond.
If you take more Xatral 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
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
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.

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.

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE XATRAL

Like all medicines, Xatral can cause side effects, although not
everybody gets them. These side effects are most likely to happen
at the start of treatment.



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.



Do not use Xatral after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



Do not store your tablets above 30°C.



Store in the original package.



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.

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)

6. FURTHER INFORMATION
What Xatral contains


The active substance in Xatral is alfuzosin hydrochloride.
Each Xatral tablet contains 2.5mg of the active ingredient
alfuzosin hydrochloride.



The other ingredients are: contains microcrystalline cellulose,
lactose, povidone, sodium starch glycollate, magnesium
stearate and purified water. The film coat contains
methylhydroxypropylcellulose, polyethylene glycol 400, and
titanium dioxide (E171).



Feeling dizzy or faint.



Headache.



Feeling sick (nausea).

What Xatral looks like and contents of the pack



Stomach pain.



Weakness or tiredness.

Xatral tablets are round and white and are marked ‘XATRAL 2.5’ on
one side and plain on the other.



General feeling of being unwell.



Feeling dizzy, lightheaded, or faint when you stand or sit up
quickly (postural hypotension).



Diarrhoea.

 Dry mouth.
Uncommon (affects less than 1 in 100 people)

Xatral are available in packs containing 30, 60 or 90 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex HA0 1DX, England.
Manufacturer
This product is manufactured by Sanofi Winthrop Industrie, Tours,
France.



Fast heart beat (tachycardia) and palpitations (pounding in the
chest and uneven heartbeat).



Chest pain.

Leaflet revision date: 09 May 2012.



Drowsiness.

Xatral is a registered trade mark of Sanofi-Synthelabo, France.



Rash and itching.



Flushes.



Water retention (may cause swollen arms or legs).



Lack of control over passing water.



Runny nose, itching, sneezing, and stuffy nose.



Visual disturbances (changes in your vision or sight).



Fainting

POM

PL No: 19488/1439

S1439 LEAFLET Xatral 20120509

Expand Transcript

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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