Xatral 10mg Prolonged Release Tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

ALFUZOSIN HYDROCHLORIDE

Mevcut itibaren:

Imbat Limited

ATC kodu:

G04CA; G04CA01

INN (International Adı):

ALFUZOSIN HYDROCHLORIDE

Doz:

10 milligram(s)

Farmasötik formu:

Prolonged-release tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Alpha-adrenoreceptor antagonists; alfuzosin

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2008-01-18

Bilgilendirme broşürü

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
XATRAL
® 10MG PROLONGED RELEASE TABLETS
(alfuzosin hydrochloride)
Your medicine is available using the name Xatral 10mg
Prolonged Release Tablets but will be referred to as Xatral
throughout this leaflet.
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:
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.
Contents of the pack and other information
1.
WHAT XATRAL 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 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

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xatral 10mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg alfuzosin hydrochloride.
Excipient(s) with known effect
Hydrogenated castor oil
For the 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
Yellow ferric oxide (E172)
Magnesium stearate
Microcrystalline cellulose
Povidone
Silica colloidal hydrated
Mannitol (E421)
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.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25˚C.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips in a cardboard carton.
Pack size 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER H