XATRAL XL 10 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS ALFUZOSIN 10,0 mg

Authorization status:

Registered

Authorization date:

2003-05-09

Patient Information leaflet

sanofi-aventis south africa (pty) ltd
Xatral XL 10 mg (prolonged release tablets)
10 mg alfuzosin hydrochloride
Date of approval: 20/02/2023
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
XATRAL XL 10 MG (PROLONGED RELEASE TABLETS)
Alfuzosin hydrochloride
Contains sugar (mannitol): 10 mg.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING XATRAL XL
10 MG.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
XATRAL XL 10 mg has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1. What XATRAL XL 10 mg is and what it is used for
2. What you need to know before you take XATRAL XL 10 mg
3. How to take XATRAL XL 10 mg
4. Possible side effects
5. How to store XATRAL XL 10 mg
6. Contents of the pack and other information.
1. WHAT XATRAL XL 10 MG IS AND WHAT IT IS USED FOR
XATRAL XL 10 mg belongs to a group of medicines called alpha-blockers.
sanofi-aventis south africa (pty) ltd
Xatral XL 10 mg (prolonged release tablets)
10 mg alfuzosin hydrochloride
Date of approval: 20/02/2023
Page 2 of 11
XATRAL XL 10 mg can be used to treat the symptoms of BENIGN PROSTATIC
HYPERPLASIA (BPH).
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 urine 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 widen
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 co

Summary of Product characteristics

sanofi-aventis south africa (pty) ltd
Xatral XL 10 mg (prolonged release tablets)
10 mg alfuzosin hydrochloride
Date of approval: 20/02/2023
Page 1 of 12
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
XATRAL XL 10 MG (prolonged release tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains 10 mg alfuzosin hydrochloride.
Contains sugar (mannitol): 10 mg
Excipients with known effects: hydrogenated castor oil 41,4 mg.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged release tablets.
Round biconvex, three-layer tablet: one white layer between two yellow
layers; diameter about
8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of functional symptoms of benign prostatic hyperplasia
(BPH).
Adjunctive therapy with urethral catheterisation for acute urinary
retention (AUR) related to BPH.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
The recommended dose for XATRAL XL 10 mg is:
sanofi-aventis south africa (pty) ltd
Xatral XL 10 mg (prolonged release tablets)
10 mg alfuzosin hydrochloride
Date of approval: 20/02/2023
Page 2 of 12
BPH: One XATRAL XL 10 mg tablet daily to be taken after meals (as
bioavailability in the
fasting state is less than half that after a meal).
AUR: One XATRAL XL 10 mg tablet daily after a meal to be taken from
the first day of
catheterisation.
METHOD OF ADMINISTRATION: The XATRAL XL 10 mg tablet must be swallowed
whole (see
section 4.4).
SPECIAL POPULATIONS
XATRAL XL 10 mg is contraindicated in patients with severe renal
impairment (creatinine
clearance
≤
30 mL/min), hepatic impairment and children below 18 years of age (see
section
4.3).
4.3 CONTRAINDICATIONS
•
Hypersensitivity to alfuzosin or any of the excipients of XATRAL XL 10
mg (see section 6.1).
•
Orthostatic hypotension (see section 4.4).
•
Combination with other alpha-1-blockers (alpha-1-adrenoceptor blockers
or antagonists).
•
Hepatic impairment.
•
Severe renal impairment (see section 4.4).
•
Children below 18 years of age.
•
Concomitan