Xatral 10mg Prolonged Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALFUZOSIN HYDROCHLORIDE

Available from:

LTT Pharma Limited

ATC code:

G04CA; G04CA01

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Dosage:

10 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Alpha-adrenoreceptor antagonists; alfuzosin

Authorization status:

Authorised

Authorization date:

2010-03-12

Patient Information leaflet

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.
IN THIS LEAFLET:
What Xatral 10mg Prolonged Release Tablets is and what it is used for
Before you take Xatral 10mg Prolonged Release Tablets
How to take Xatral 10mg Prolonged Release Tablets
Possible side effects
How to store Xatral 10mg Prolonged Release Tablets
Further information
WHAT XATRAL 10MG PROLONGED RELEASE TABLETS IS AND
WHAT IT IS USED FOR
The name of your tablet is Xatral. It contains a medicine called
alfuzosin
hydrochloride.
This belongs to a group of medicines called alpha-blockers.
Xatral 10mg Prolonged Release Tablets 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 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

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 section 6.1
3 PHARMACEUTICAL FORM
Tablet, prolonged release
_Product imported from 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 PA0540/162/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
ethylcellulose
hydrogenated castor oil
hypromellose
iron oxide yellow (E172)
magnesium stearate
microcrystalline cellulose
povidone
collidal hydrated silica
mannitol
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister strips and outer carton 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.
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6.5 NATURE AND CONTENTS OF CONTAINER
Boxes with tablets in PVC/foil blister strips, 30 tablets per pack.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
No Special requirements
7 PARALLE