Xatral 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alfuzosin hydrochloride

Available from:

Sanofi

ATC code:

G04CA01

INN (International Name):

Alfuzosin hydrochloride

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040100; GTIN: 5026474000013

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
XATRAL
® 2.5MG
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 2.5mg
Tablets but will be referred to as Xatral
throughout this leaflet.
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.
Further information
1. WHAT XATRAL IS AND
WHAT IT IS USED FOR
The name of your tablets is Xatral. This
belongs to a group of medicines called
alpha-blockers.
Xatral can be used to treat the symptoms of
BENIGN PROSTATIC HYPERTROPHY. 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.
2. BEFORE YOU TAKE XATRAL
DO NOT TAKE XATRAL IF:

You are allergic (hypersensitive) to
alfuzosin or any of the other ingredients
of Xatral (see section 6). Signs of an
allergic reaction include: a rash,
swallowing or breathing problems,
swelling of your lips, throat, or tongue.

You are taking another alpha-blocker.
See section below on ‘Taking other
medicines’.

You have s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Xatral 2.5 mg film coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg alfuzosin hydrochloride.
Excipient: Lactose
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film coated tablet
White round tablet marked Xatral 2.5 on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Xatral tablets should be swallowed whole. The first dose should be
given just
before bedtime.
Adults
The usual dose is one tablet three times daily. The dose may be
increased to a
maximum of 4 tablets (10mg) per day depending on the clinical
response.
Elderly and treated hypertensive patients
As a routine precaution when prescribing alfuzosin to elderly patients
(aged
over 65 years) and the treated hypertensive patient, the initial dose
should be 1
tablet in the morning and 1 tablet in the evening.
Renal insufficiency
In patients with renal insufficiency, as a precaution, it is
recommended that the
dosing be started at Xatral 2.5mg twice daily adjusted according to
clinical
response.
Hepatic insufficiency
In patients with mild to moderate hepatic insufficiency, it is
recommended that
therapy should commence with a single dose of Xatral 2.5mg/day to be
increased to Xatral 2.5mg twice daily according to clinical response.
Paediatric population
Efficacy of alfuzosin has not been demonstrated in children aged 2 to
16 years
(see section 5.1). Therefore, alfuzosin is not indicated for use in
the paediatric
population.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or any of the excipients (see
Section 6.1
List of excipients);
•
history of orthostatic hypotension;
•
combination with other alpha-1 receptor blockers;
•
severe hepatic insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As
with
all
alpha-1-blockers,
in
some
subjects,
in
particular
patients
receiving
antihypertensive
med