XATRAL 10 Milligram Tablet Prolonged Release

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALFUZOSIN HYDROCHLORIDE

Available from:

B & S Healthcare

ATC code:

G04BX01

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Dosage:

10 Milligram

Pharmaceutical form:

Tablet Prolonged Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other urologicals

Authorization status:

Authorised

Authorization date:

2009-05-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

XATRAL
®
 10MG PROLONGED RELEASE TABLETS 

(alfuzosin hydrochloride) 
_ _
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. 

The name of your tablet is Xatral 10mg Prolonged Release 
Tablets but will be referred to as Xatral throughout this
leaflet. 

IN THIS LEAFLET: 
1. What Xatral is and what it is used for 
2. Before you take Xatral 
3. How to take Xatral 
4. Possible side effects 
5. How to store Xatral 
6. Further information 

1.  WHAT XATRAL IS AND WHAT IT IS USED FOR 

It contains a medicine called alfuzosin hydrochloride. This 
belongs to a group of medicines called alpha-blockers.  
Xatral can be used to treat the symptoms of Benign Prostatic 
Hypertrophy (BPH). This is when the prostate gland enlarges 
(hypertrophy) 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 hypertrophy, the 
prostate gland gets so big t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xatral 10mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg alfuzosin hydrochloride.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet, prolonged release
_Product imported from Italy and the UK:_
Round biconvex three layer tablet; one white layer between two yellow layers.
4 CLINICAL PARTICULARS
As per PA0540/162/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/152/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Ethylcellulose 20
Hydrogenated castor oil
Hypromellose
Yellow ferric oxide
Magnesium stearate
Microcrystalline cellulose,
Povidone
Silica colloidal hydrated
Mannitol
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC. Store in the original package.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 16/02/2015_
_CRN 2157663_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
30 tablets in PVC/foil blister strips in an over-labelled outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
B & S Healthcare
Unit 4
Bradfield Road
Ruislip
Middlesex
HA4 0NU
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1328/104/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28
th
May 2009
10 DATE OF REVISION OF THE TEXT
February 2015
HEALTH PRODUCTS REGULATORY AUTHORITY
_____________________________________________________________________________________