Xatral XL 10mg prolonged-release tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ALFUZOSIN HYDROCHLORIDE

Disponible depuis:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

Code ATC:

G04CA01

DCI (Dénomination commune internationale):

ALFUZOSIN HYDROCHLORIDE 10 mg

forme pharmaceutique:

PROLONGED-RELEASE TABLET

Composition:

ALFUZOSIN HYDROCHLORIDE 10 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

UROLOGICALS

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-05-26

Notice patient

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_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NAME OF THE MEDICINAL PRODUCT
XATRAL XL 10 MG, PROLONGED-RELEASE TABLET
_ALFUZOSIN HYDROCHLORIDE _
BOXED TEXT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Xatral XL 10 mg prolonged-release tablets is and what it is
used for
2. What you need to know before you take Xatral XL 10 mg
prolonged-release tablets
3. How to take Xatral XL 10 mg prolonged-release tablets
4. Possible side effects
5. How to store Xatral XL 10 mg prolonged-release tablets
6. Contents of the pack and other information
1.
WHAT XATRAL XL 10MG PROLONGED-RELEASE TABLETS IS AND WHAT IT IS USED
FOR
Pharmacotherapeutic group - ALPHA-BLOCKERS - ATC code: G04CA01 - G:
genito-urinary system
and sex hormones
Xatral contains alfuzosin. This medicine belongs to a group of
medicines called alpha-blockers. It has
an effect on the bladder, the tube which takes urine outside of the
body (the urethra) and the prostate.
Xatral is used when your prostate increases in size (benign prostatic
hyperplasia):
•
to make it easier to urinate,
•
or in addition to the urine being drained using a catheter in your
bladder, when it is impossible to
urinate.
This medicine is for use in men only.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XATRAL XL 10 MG
PROLONGED-RELEASE TABLETS
DO NOT TAKE XATRAL XL 10 MG, PROLONGED-RELEASE TABLET:
•
if you are allergic to the active substance (alfuzosin) or any of the
other ingredients of

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
XATRAL XL 10 MG, PROLONGED-RELEASE TABLET
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alfuzosin hydrochloride
...................................................................................................................
10 mg
for one prolonged-release tablet.
Excipient with known effects: Hydrogenated castor oil
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Treatment of functional symptoms of benign prostatic hypertrophy
(BPH).
•
Adjuvant treatment to a catheter in acute urinary retention (AUR)
related to benign prostatic
hypertrophy.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Oral use.
The recommended dosage is one 10 mg tablet daily, to be taken
immediately after the evening meal.
Adjunctive treatment for bladder catheterization in acute urinary
retention associated with benign
prostatic hypertrophy:
The recommended dosage is one 10 mg tablet daily, to be taken after a
meal, starting on the day of
insertion of the urethral catheter.
The treatment is administered for 3 to 4 days including 2 to 3 days
during catheterization and 1 day
following catheter removal.
_Paediatric population_
_ _
The
efficacy
of
alfuzosin
has
not
been
demonstrated
in
children
aged
2
to
16
years
old
(see section 5.1). Consequently, alfuzosin should not be used in the
paediatric population.
METHOD OF ADMINISTRATION
The tablet must be swallowed whole with a glass of water (see section
4.4).
4.3.
CONTRAINDICATIONS
This medicinal product must not be given in the following situations:
•
Hypersensitivity to alfuzosin and/or to any of the other components,
•
Postural hypotension,
•
Liver failure,
•
Severe kidney failure (creatinine clearance < 30 mL/min),
•
In combination with potent CYP3A4 inhibitors (see section 4.5).
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR US