Xatral SR

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Alfuzosin hydrochloride

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

XATRAL
®
 SR

(ZAR-TREL)
_Alfuzosin (al-few-zo-sin)_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xatral SR tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT XATRAL IS USED
FOR
Xatral belongs to a group of
medicines called alpha1-receptor
blockers.
Xatral is used to treat a medical
condition in men called Benign
Prostatic Hyperplasia or BPH. BPH
is a condition where the prostate
gland (which is near your bladder)
has become bigger making it more
difficult for you to pass urine. This
can lead to symptoms such as:
•
Weak or interrupted stream of
urine
•
Feeling that you cannot empty
your bladder completely
•
Delay before you start to pass
urine
•
Needing to pass urine often,
especially at night
•
Feeling that you must pass urine
right away.
Xatral works by relaxing the muscles
in the prostate gland and increasing
the flow of urine.
Your doctor, however, may prescribe
Xatral for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE XATRAL IF YOU HAVE LIVER
DISEASE.
DO NOT TAKE XATRAL IF YOU ARE
CURRENTLY TAKING ANOTHER ALPHA-
BLOCKER.
These include prazosin (Minipress),
terazosin (Hytrin) and tamsulosin
(Flomaxtra).
DO NOT TAKE XATRAL IF YOU HAVE A
HISTORY OF FEELING DIZZY, TIRED OR
SWEATING ON STANDING (ORTHOSTATIC
HYPOTENSION).
DO NOT TAKE XATRAL IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENT

Summary of Product characteristics

PRODUCT INFORMATION  
May 2013

Xatral SR - alfuzosin hydrochloride 

xatral-sr-ccdsv10-piv8-28may13                                                            

                     P
age

1 
PRODUCT INFORMATION 
XATRAL
® 
SR 
NAME OF MEDICINE 
AUSTRALIAN APPROVED NAME 
Alfuzosin hydrochloride 
CHEMICAL STRUCTURE 

Molecular Formula:  
Molecular Weight: 425.9 
Chemical Name: (+,-)
N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] 
tetrahydro-2-furancarboxamide hydrochloride 
CAS REGISTRY NUMBER 
81403-68-1 
DESCRIPTION 
Xatral (alfuzosin hydrochloride) is an
orally active quinazoline derivative. 
Alfuzosin hydrochloride is a white to off white crystalline powder.  It
is freely soluble in water. 
N
N
CH
3
O
CH
3
O
NH
2
N
CH
3
NH
O
O
.HCl
PRODUCT INFORMATION  
May 2013

Xatral SR - alfuzosin hydrochloride 

xatral-sr-ccdsv10-piv8-28may13                                                            

                     P
age

2 
The 10MG
PROLONGED RELEASE TABLETS are three layered, yellow and
white biconvex tablets.  Each 
tablet contains 10mg of alfuzosin
hydrochloride as the active ingredient and ethylcellulose, 
hydrogenated castor oil, hypromellose, yellow iron oxide,
magnesium stearate, microcrystalline 
cellulose, povidone,
silica colloidal hydrated and mannitol as excipients. 
PHARMACOLOGY 
PHARMACODYNAMICS 
MECHANISM OF ACTION 
Alfuzosin is a selective antagonist of postsynaptic 
α1-adrenoreceptors. In vitro pharmacology 
studies have documented the antagonist properties of al