Xatral 10mg Prolonged Release Tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

ALFUZOSIN HYDROCHLORIDE

Beszerezhető a:

PCO Manufacturing Ltd.

ATC-kód:

G04CA; G04CA01

INN (nemzetközi neve):

ALFUZOSIN HYDROCHLORIDE

Adagolás:

10 milligram(s)

Gyógyszerészeti forma:

Prolonged-release tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Alpha-adrenoreceptor antagonists; alfuzosin

Engedélyezési státusz:

Authorised

Engedély dátuma:

2005-02-11

Betegtájékoztató

_ _
_ _
PACKAGE LEAFLET : INFORMATION FOR THE USER
XATRAL
® 10MG
PROLONGED RELEASE TABLETS
alfuzosin hydrochloride
Is this leaflet hard to see or read? Phone [phone] for help.
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 10mg Prolonged Release Tablet 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 TABLET 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.

Termékjellemzők

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 Greece, the UK and Italy:_
Round three layer tablet with 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
Hypromellose
Hydrogenated castor oil
Ethylcellulose
Yellow ferric oxide (E172)
Magnesium stearate
Colloidal hydrated silica
Mannitol (E421)
Povidone
Microcrystalline cellulose
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 package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Keep in the original package.
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack of 30 tablets contained in an over-labelled outer
cardboard carton.
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 specia