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XATRAL 2.5MG TABLETS

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Variation App 2. Assessed against UK PIL dated February 2005
By keddies at 1:45 pm, 12/6/05

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XATRAL 2.5MG TABLETS /
ALFUZOSIN HYDROCHLORIDE 2.5MG TABLETS
(alfuzosin hydrochloride)
PATIENT INFORMATION LEAFLET

By Meher Talati at 10:28 am, 12/5/05

Your medicine is available using either of the above names, but will
be referred to as Xatral throughout this leaflet.
Please read this leaflet carefully before you start to take your
medicine. This leaflet provides a summary of the information
available on your medicine. It is not designed to replace your
doctor s instructions but to guide you in the safe use of this
medicine. If you have any questions or are not sure about anything,
ask your doctor or pharmacist.
GENERAL INFORMATION ABOUT XATRAL TABLETS
Each tablet contains 2.5 mg alfuzosin hydrochloride as the active
ingredient.
Alfuzosin Hydrochloride is an alpha blocker. It relaxes the muscle of
the Prostrate Gland, the Urethra, and the Bladder, making it easier
to pass urine.
The tablets also contain: microcrystalline cellulose, lactose,
povidone, sodium starch glycollate, magnesium stearate,
hypromellose, macrogol 400, and titanium dioxide (E171).
Xatral tablets are white, round film coated tablets marked ALZ on
one side and 2.5 on the reverse.
Your tablets are available in blister packs of 60.
Your medicine is manufactured by: Synthelabo Groupe, 37001
Tours, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd,
Kirk Sandall, Doncaster, DN3 1QR.
POM

PL No: 04423/ 0539

WHAT IS IT FOR?
Xatral is used for treating the symptoms of Benign Prostatic
Hypertrophy (BPH). BPH means that the prostate gland enlarges
(hypertrophy) but the growth is not cancerous (it is benign). This
occurs mainly in older men and is fairly common.
The prostate gland is just underneath the bladder. The urethra (the
tube through which urine passes from the bladder to the outside of
the body) runs through the prostate gland. If the prostate enlarges,
it presses on the urethra, causing it to narrow. This makes it difficult
to pass urine.
Xatral relaxes the muscle of the prostate gland, widening the urethra
and so relieving the symptoms of BPH.
BEFORE YOU TAKE THESE TABLETS
You should not take this medicine if:
You have postural hypotension (low blood pressure, causing a

feeling of dizziness or faintness when standing up) or have had
it in the past.
You are taking another alpha-blocker, nitrates or drugs

affecting dopamine in the brain. Please check with your doctor.
You have severe liver problems.

You are allergic to alfuzosin hydrochloride.

You are allergic to any of the ingredients in the tablets (listed

above).
If you have any of the following conditions, make sure your doctor
knows about them before you take these tablets. Tell your doctor if:
You have been allergic to an alpha-blocker in the past.

You are taking any medicines for high blood pressure.

If you have high blood pressure your doctor should measure your
blood pressure regularly while you are taking Xatral. This is
particularly important at the start of treatment.
You have angina (chest pain) whether or not you are taking

any medicines for it.
In the above cases it may still be all right for you to take Xatral.
Your doctor will be able to decide whether it is suitable for you.
If you have been told by your Doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

ARE THERE ANY DRUG INTERACTIONS WITH XATRAL?
These tablets may interact with other alpha-blockers and with
antihypertensive agents (medicines used to treat high blood
pressure), causing your blood pressure to fall too low.
Anaesthesia
If you have a general anaesthetic while you are taking Xatral, your
blood pressure could fall very low, which is dangerous. If you are to
undergo an operation which requires a general anaesthetic, Xatral
should be stopped 24 hours beforehand.
HOW TO TAKE XATRAL
Swallow your tablets whole with plenty of water. The first dose
should be taken just before bedtime.
Adults under 65 years:
The usual dose is one tablet three times a day. Your doctor may
increase this to four times a day if needed.
Adults over 65 years, patients taking medicines for high blood
pressure, or patients with poor kidney function:
The usual dose is one tablet in the morning and one tablet in the
evening.
Adults with liver problems:
The usual dose is one tablet per day. Your doctor may increase this
to one tablet in the morning and one tablet in the evening.
Note - Follow your doctor s instructions about when and how to
take your medicine and read the label on the carton. If you are
unsure about anything, ask your doctor or pharmacist.
WHAT TO DO IF YOU TAKE TOO MANY TABLETS
IF YOU OR SOMEONE YOU KNOW ACCIDENTALLY TAKES TOO
MANY XATRAL TABLETS, CONTACT A DOCTOR OR YOUR
LOCAL HOSPITAL CASUALTY DEPARTMENT IMMEDIATELY
AND SAY HOW MANY TABLETS HAVE BEEN TAKEN. LIE
DOWN AS MUCH AS POSSIBLE: THIS WILL HELP TO MINIMISE
THE SIDE EFFECTS.
WHAT TO DO IF YOU MISS ONE OR MORE DOSES
If you forget to take a tablet do not take a double dose the next time.
Miss it out and continue taking your usual dose at the usual time.
DOES XATRAL HAVE SIDE EFFECTS?
As with all medicines, Xatral can have side effects. However, not
everyone gets side effects. Side effects are most likely to happen at
the start of treatment. The most common side effects are dizziness,
a general feeling of being unwell, headache, nausea (feeling sick),
stomach pain and diarrhoea. Less common side effects are dry
mouth, postural hypotension (low blood pressure), fainting,
tachycardia (fast heartbeat), palpitations, chest pain, tiredness,
drowsiness, rash, itching, flushes and oedema (swelling, usually of
the lower legs). Very rarely, priapism (persistent an often painful
erection in the absence of sexual stimulation) has been reported in
patients receiving Xatral, or other medicines like Xatral.
If you get angina (chest pain) or your angina is getting worse, stop
taking your tablets and contact a doctor immediately. This only
usually happens if you have had angina before.
Talk to your doctor if you notice any other side effects not mentioned
above, or a general change in your health whilst taking this
medicine.
HOW TO STORE THIS MEDICINE
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Keep your medicine away from damp areas including radiators
(heaters). Do not store Xatral above 30 C. Store in the original
package. Do not take this medicine after the month shown on the
pack. If you have any unused medicine, please return this to your
pharmacist for safe disposal.
If your medicine appears to be discoloured or shows any other signs
of deterioration, please return to your pharmacist who will advise
you.
REMEMBER
This medicine is for you. Only a doctor can prescribe it for you.
Never give it to someone else, even if their symptoms are the same
as yours; it may harm them.
Leaflet revision & issue date (Ref): 08.11.05


Xatral is a registered trademark of Sanofi-Synthelabo.

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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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