Xatral XL 10mg tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Alfuzosin hydrochloride

Disponibbli minn:

Dowelhurst Ltd

Kodiċi ATC:

G04CA01

INN (Isem Internazzjonali):

Alfuzosin hydrochloride

Dożaġġ:

10mg

Għamla farmaċewtika:

Modified-release tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 07040100

Fuljett ta 'informazzjoni

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
XATRAL
®
XL 10MG TABLETS
(alfuzosin hydrochloride)
Your medicine is available using the name Xatral XL 10mg
Tablets but will be referred to as Xatral XL 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 XL is and what it is used for
2.
Before you take Xatral XL
3.
How to take Xatral XL
4.
Possible side effects
5.
How to store Xatral XL
6.
Further information
1.
WHAT XATRAL XL IS AND WHAT IT IS USED FOR
The name of your tablets is Xatral XL. This belongs to a group
of medicines called alpha-blockers.
Xatral XL can be used to treat the symptoms of BENIGN
PROSTATIC HYPERPLASIA. This is when the prostate gland
enlarges (hyperplasia) 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 hyperplasia, 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 and relieves

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Xatral XL 10 mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg alfuzosin hydrochloride.
Excipient: Hydrogenated castor oil
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Prolonged release tablet.
Round biconvex, three layer tablet: one white layer between two yellow
layers.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy
(BPH).
For information on use in acute urinary retention (AUR) related to BPH
see
sections 4.2 and 5.1.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Xatral XL should be swallowed whole (see section 4.4).
BPH: The recommended dose is one 10mg tablet to be taken once daily
after a
meal.
AUR: In patients 65 years and older, one 10 mg tablet daily after a
meal to be
taken
from
the
first
day
of
catheterisation.
The
treatment
should
be
administered for 3-4 days, 2-3 days during catheterisation and 1 day
after its
removal. In this indication no benefit has been established in
patients under
65 years of age or if treatment is extended beyond 4 days.
Paediatric Population
Efficacy of Xatral XL has not been demonstrated in children aged 2 to
16
years (see section 5.1). Therefore Xatral XL is not indicated for use
in the
paediatric population.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
(see Section
6.1 List of excipients);
•
history of orthostatic hypotension;
•
combination with other alpha-1 receptor blockers;
•
hepatic insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As
with
all
alpha-1-blockers
in
some
subjects,
in
particular
patients
receiving
antihypertensive
medications
or
nitrates,
postural
hypotension
with
or
without
symptoms (dizziness, fatigue, sweating) may develop within a few hours
following
administration. In such cases, the patient should lie down until the
symptoms have
completely disappeared.
These effects are transient