XATRAL SR TABLET 5 mg

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

ALFUZOSIN HCl

Saatavilla:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC-koodi:

G04CA01

Annos:

5 mg

Lääkemuoto:

TABLET, EXTENDED RELEASE

Koostumus:

ALFUZOSIN HCl 5 mg

Antoreitti:

ORAL

Prescription tyyppi:

Prescription Only

Valmistaja:

SANOFI WINTHROP INDUSTRIE

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

1997-11-21

Pakkausseloste

XATRAL 
® 
ALFUZOSIN 
5mg Sustained Release Film-coated Tablet 
[sanofi logo] 
COMPOSITION 
Each tablet contains 5mg Alfuzosin hydrochloride. 

PHARMACEUTICAL FORM 
A sustained release, pale yellow, biconvex, scored film-coated
tablet. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Treatment of functional symptoms of benign prostatic hyperplasia. 

DOSAGE AND METHOD OF ADMINISTRATION 
Oral use. 
The tablet must be swallowed whole with a glass of water 
_(see Special warnings and special precautions for use). _

_Adults _
One XATRAL SR 5 mg tablet morning and evening. 

_In elderly patients or patients treated for hypertension:_
 as a systematic 
precaution, it is recommended that treatment be started with one
XATRAL SR 5 
mg tablet in the evening and that the dosage then be increased on
the basis of 
the patient’s individual response, without exceeding the maximum
dosage of one 
XATRAL SR 5 mg tablet morning and evening. 

_Patients with impaired liver function:_
 it is recommended that treatment be started 
with one XATRAL 2.5 mg tablet per day and that the dosage then be
increased 
on the basis of the patient’s individual response, without exceeding
one XATRAL 
2.5 mg tablet twice daily. 

CONTRAINDICATIONS 
This medicinal product must not be administered in the following
situations: 
-  hypersensitivity to alfuzosin and/or any of the other
ingredients; 
-  postural  hypotension; 
-  severe liver failure (class C in the Child-Pugh
classification); 
-  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 
com

Valmisteyhteenveto

XATRAL
®
ALFUZOSIN
5mg Sustained Release Film-coated Tablet
[sanofi logo]
COMPOSITION
Each tablet contains 5mg Alfuzosin hydrochloride.
PHARMACEUTICAL FORM
A sustained release, pale yellow, biconvex, scored film-coated tablet.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of functional symptoms of benign prostatic hyperplasia.
DOSAGE AND METHOD OF ADMINISTRATION
Oral use.
The tablet must be swallowed whole with a glass of water
_(see Special warnings and special precautions for use). _
_Adults _
One XATRAL SR 5 mg tablet morning and evening.
_In _
_elderly _
_patients _
_or _
_patients _
_treated _
_for _
_hypertension:_
as
a
systematic
precaution, it is recommended that treatment be started with one
XATRAL SR 5
mg tablet in the evening and that the dosage then be increased on the
basis of
the patient’s individual response, without exceeding the maximum
dosage of one
XATRAL SR 5 mg tablet morning and evening.
_Patients with impaired liver function:_ it is recommended that
treatment be started
with one XATRAL 2.5 mg tablet per day and that the dosage then be
increased
on the basis of the patient’s individual response, without exceeding
one XATRAL
2.5 mg tablet twice daily.
CONTRAINDICATIONS
This medicinal product must not be administered in the following
situations:
- hypersensitivity to alfuzosin and/or any of the other ingredients;
- postural hypotension;
- severe liver failure (class C in the Child-Pugh classification);
- 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 a