Xatral XL 10mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Alfuzosin hydrochloride

Предлага се от:

Sanofi

АТС код:

G04CA01

INN (Международно Name):

Alfuzosin hydrochloride

дозиране:

10mg

Лекарствена форма:

Modified-release tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 07040100; GTIN: 5026474000846 5026474000853

Листовка

PACKAGE LEAFLET:
INFORMATION FOR THE USER
XATRAL XL 10MG 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 gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
The name of your medicine is Xatral XL
10mg tablets but will be referred to as Xatral
XL throughout this leaflet.
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
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 the pain.

During this time, Xatral XL may be used to
help the water

Данни за продукта

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