XATRAL XL 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALFUZOSIN HYDROCHLORIDE

Available from:

SANOFI ISRAEL LTD

ATC code:

G04CA01

Pharmaceutical form:

TABLETS PROLONGED RELEASE

Composition:

ALFUZOSIN HYDROCHLORIDE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SANOFI WINTHROP INDUSTRIE, FRANCE

Therapeutic group:

ALFUZOSIN

Therapeutic area:

ALFUZOSIN

Therapeutic indications:

Treatment of certain functional symptoms of benign prostatic hypertrophy particularly if surgery has to be delayed for some reason. Adjuvant treatment to a catheter in acute urinary retention related to benign prostatic hypertrophy.

Authorization date:

2021-07-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed by doctor’s prescription only
XATRAL XL 10 MG
PROLONGED-RELEASE TABLETS
Each prolonged release tablet contains: alfuzosin HCl 10 mg.
Inactive ingredients and allergens: see Section 6 ‘Additional
information’.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If
you have further questions, refer to the doctor or pharmacist.
This medicine was prescribed for you. Do not pass it on to others. It
can harm them even if it seems to you that their medical condition
is similar to yours. The medicine is intended for men.
This medicine is not intended for treating children and adolescents
under 16 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
Xatral is used to treat symptoms of benign growth of the prostate,
particularly if surgery is delayed, and as adjuvant treatment to
a catheter in acute urinary retention related to benign prostatic
hypertrophy.
THERAPEUTIC GROUP:
Xatral XL belongs to a group of medicines called alpha blockers,
and it is a selective blocker of the α1 (alpha one) receptor.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
•
if you are sensitive (allergic) to alfuzosin or to any of the
ingredients of the medicine (see Section 6)
•
if you have or have had orthostatic hypotension (sudden drop
in blood pressure that occurs when suddenly getting up from a
sitting or lying position)
•
in combination with other α1-blockers
•
if you have an impaired liver function
SPECIAL WARNINGS RELATING TO USE OF THE MEDICINE
TALK TO YOUR DOCTOR BEFORE TAKING THIS MEDICINE:
•
If
you
show
symptoms
of
orthostatic
hypotension
(sudden
drop in blood pressure when changing position). Orthostatic
hypotension may occur in the first few hours after taking this
medicine.
This
is
especially
common
at
the
beginning
of
treatment and when you are also being treated for increased
blood pressure or have a cardiac

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Xatral XL 10 mg prolonged-release tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is alfuzosin. Each tablet contains 10 mg
alfuzosin hydrochloride.
Excipient with known effect: each tablet contains 41.4 mg hydrogenated
castor oil.
For the 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 certain functional symptoms of benign prostatic
hypertrophy (BPH), particularly if
surgery has to be delayed for some reason.
Adjuvant treatment to a catheter in acute urinary retention (AUR)
related to benign prostatic
hypertrophy.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
The tablet must be swallowed whole with a glass of water (see section
4.4 Special warnings and
special precautions for use).
BPH: The recommended dosage is one 10-mg tablet per day, to be taken
immediately after the
evening meal.
AUR: The recommended dosage is one 10-mg tablet per day, to be taken
after the evening meal,
starting on the day of insertion of the urethral catheter.
The treatment is administered for 3 to 4 days, with 2 to 3 days during
catheterisation and 1 day
following its removal.
Paediatric patients
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 paediatric
population.
4.3. CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
2/8
- Antecedents of orthostatic hypotension.
- Combination with other alpha-1 blockers.
- Hepatic insufficiency.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Warnings
As with all

1
-blockers, orthostatic hypotension may occur during the first few
hours after intake of
the medicinal product, especially at the beginning of the treatment,
especially in individuals treated
wit