Xatral 10mg Prolonged Release Tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

ALFUZOSIN HYDROCHLORIDE

Saadav alates:

IMED Healthcare Ltd.

ATC kood:

G04CA; G04CA01

INN (Rahvusvaheline Nimetus):

ALFUZOSIN HYDROCHLORIDE

Annus:

10 milligram(s)

Ravimvorm:

Prolonged-release tablet

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Alpha-adrenoreceptor antagonists; alfuzosin

Volitamisolek:

Authorised

Loa andmise kuupäev:

2009-03-06

Infovoldik

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 onto others.
It may harm them, even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Xatral 10mg Prolonged Release Tablets is and what it is used
for
2.
Before you take Xatral 10mg Prolonged Release Tablets
3.
How to take Xatral 10mg Prolonged Release Tablets
4.
Possible side effects
5.
How to store Xatral 10mg Prolonged Release Tablets
6.
Further information
1.
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

Toote omadused

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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet, prolonged release.
_Product imported from the UK and Italy_:
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
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 is the date shown on the
container and outer carton of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package.
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6.5 NATURE AND CONTENTS OF CONTAINER
Boxes of 30 tablets in blister strips. Each pack contains 3 blister
strips of 10 tablets in an over-labelled cardboard outer
carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND