XATRAL XL TABLET 10 mg

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

ALFUZOSIN HCl

Disponible des:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Codi ATC:

G04CA01

Dosis:

10 mg

formulario farmacéutico:

TABLET

Composición:

ALFUZOSIN HCl 10 mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricat per:

SANOFI WINTHROP INDUSTRIE

Estat d'Autorització:

ACTIVE

Data d'autorització:

2001-07-05

Informació per a l'usuari

XATRAL
®

_Alfuzosin _
10mg Prolonged-Release Tablet 
 [sanofi logo] 

COMPOSITION: 
Alfuzosin hydrochloride ......................................... 10
mg 

PHARMACEUTICAL FORM 
Prolonged-release tablet. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Treatment of the functional symptoms of benign prostatic hypertrophy
(BPH). Adjuvant 
treatment to a catheter in first episode of acute urinary retention
(AUR) related to benign 
prostatic hypertrophy (BPH). 

POSOLOGY AND METHOD OF ADMINISTRATION 
Benign Prostatic Hypertrophy (BPH): 
The recommended dosage is one 10-mg tablet per day, to be
taken immediately after 
the evening meal. 
Adjuvant treatment to a catheter in the first episode of acute
urinary retention related to 
benign prostatic hypertrophy: 
The recommended dosage is one 10-mg tablet per day, to be
taken after a meal, from 
the first day of catheterization onwards. 
The treatment is administered for 3 to 4 days, i.e. 2 to 3 days while
the catheter is in 
place and 1 day after it is removed. 
The tablet must be swallowed whole with a glass of water (see Special
warnings and 
special precautions for use). 

CONTRAINDICATIONS 
This medicine must not be administered in the following situations: 
-  hypersensitivity to alfuzosin and/or any of the other
ingredients; 
- postural hypotension, 
-  liver failure ; 
-  severe kidney failure (creatinine clearance <30 ml/min), 
-  in combination with ritonavir 

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
_WARNINGS _
As with all alpha-1 blockers, some patients, and in particular those
treated with 
antihypertensives may experience postural hypotension within a
few hours following 
administration, possibly with symptoms (dizzy sensations, fatigue,
sweating). 

If this occurs, patient should remain lying down until the symptoms
have completely 
subsided. 

These effects are usually transient, occur at the beginning of
treatment and do not 
generally prevent continued tre

Fitxa tècnica

XATRAL
®
_Alfuzosin _
10mg Prolonged-Release Tablet
[sanofi logo]
COMPOSITION:
Alfuzosin hydrochloride ......................................... 10
mg
PHARMACEUTICAL FORM
Prolonged-release tablet.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy
(BPH). Adjuvant
treatment to a catheter in first episode of acute urinary retention
(AUR) related to benign
prostatic hypertrophy (BPH).
POSOLOGY AND METHOD OF ADMINISTRATION
Benign Prostatic Hypertrophy (BPH):
The recommended dosage is one 10-mg tablet per day, to be taken
immediately after
the evening meal.
Adjuvant treatment to a catheter in the first episode of acute urinary
retention related to
benign prostatic hypertrophy:
The recommended dosage is one 10-mg tablet per day, to be taken after
a meal, from
the first day of catheterization onwards.
The treatment is administered for 3 to 4 days, i.e. 2 to 3 days while
the catheter is in
place and 1 day after it is removed.
The tablet must be swallowed whole with a glass of water (see Special
warnings and
special precautions for use).
CONTRAINDICATIONS
This medicine must not be administered in the following situations:
- hypersensitivity to alfuzosin and/or any of the other ingredients;
- postural hypotension,
- liver failure ;
- severe kidney failure (creatinine clearance <30 ml/min),
- in combination with ritonavir
- Concomitant administration with potent CYP3A4 inhibitors
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_WARNINGS _
As
with
all
alpha-1
blockers,
some
patients,
and
in
particular
those
treated
with
antihypertensives may experience postural hypotension within a few
hours following
administration, possibly with symptoms (dizzy sensations, fatigue,
sweating).
If this occurs, patient should remain lying down until the symptoms
have completely
subsided.
These effects are usually transient, occur at the beginning of
treatment and do not
generally prevent continued treatment. Pronounced drop in blood
pressure has been
reported in post-marketing s