Xatral 2.5mg Film-Coated 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:

2.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Alpha-adrenoreceptor antagonists; alfuzosin

Authorization status:

Authorised

Authorization date:

2014-06-13

Patient Information leaflet

XATRAL 2.5MG FILM-COATED 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 get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
What Xatral 2.5mg Film-coated Tablets is and what it is used for
Before you take Xatral 2.5mg Film-coated Tablets
How to take Xatral 2.5mg Film-coated Tablets
Possible side effects
How to store Xatral 2.5mg Film-coated Tablets
Further information
WHAT XATRAL 2.5MG FILM-COATED 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 2.5mg Film-coated 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.
BEFORE YOU TAKE XATRAL 2.5MG FILM-COATED TABLETS
DO NOT TAKE XATRAL 2.5MG FILM-COATED TABLETS IF:
*
You are allergic (hypersensitive) to alfuzosin or any of the other
ingredients
of Xatral (see section 6: Further Information). Signs of an allergic
reaction
include: a rash, swallowing or breathing problems, swelling of your
lips,
throat, or tongue.
*

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xatral 2.5mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg alfuzosin hydrochloride.
Excipients: Also contains Lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
_Product imported from UK_
White round, film coated tablet engraved on one side with ‘Xatral
2.5’.
4 CLINICAL PARTICULARS
As per PA0540/162/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/162/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
TABLET CORE
Microcrystalline cellulose
Lactose
Povidone
Sodium starch glycollate
Magnesium stearate.
COATING
Methylhydroxypropylcellulose
Polyethylene glycol 400
Titanium dioxide suspension (E171).
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 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 25ºC.
Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Boxes with 60 tablets in PVC/foil blister strips.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODU