Xatral 10mg Prolonged Release Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Alfuzosin hydrochloride

Disponível em:

Sanofi-Aventis Ireland Limited T/A SANOFI

Código ATC:

G04CA; G04CA01

DCI (Denominação Comum Internacional):

Alfuzosin hydrochloride

Dosagem:

10mg milligram(s)

Forma farmacêutica:

Prolonged-release tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Alpha-adrenoreceptor antagonists; alfuzosin

Status de autorização:

Marketed

Data de autorização:

2000-05-26

Folheto informativo - Bula

1.
NAME OF THE MEDICINAL PRODUCT
Xatral 10mg Prolonged Release Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg alfuzosin hydrochloride.
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Tablet, prolonged release.
Round biconvex three layer tablet: one white layer between two yellow
layers.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy.
Adjunctive therapy with urethral catheterisation for Acute Urinary
Retention related to BPH.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Xatral 10mg prolonged release tablets are for oral administration.
Xatral 10mg Prolonged Release Tablets should be swallowed whole.
BPH: The recommended dose is one 10mg tablet once daily to be taken
after a meal.
AUR: One 10mg tablet daily after a meal to be taken from the first day
of catheterisation.
Paediatric population:
Efficacy of Xatral has not been demonstrated in children aged 2 to 16
years (see section 5.1).
Therefore, Xatral is not indicated for use in paediatric population.
4.3
CONTRAINDICATIONS

Hypersensitivity to alfuzosin or any component.

History of orthostatic hypotension.

Combination with other alpha
1
-blockers.

Hepatic insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with all alpha
1
-blockers in some subjects, in particular patients receiving
antihypertensive
medications or nitrates. In some subjects postural hypotension may
develop, with or without
symptoms (dizziness, fatigue, sweating) within a few hours following
administration. These effects
are usually transient, occur at the beginning of treatment and do not
usually prevent the continuation
of treatment. In such cases, the patient should lie down until the
symptoms have completely
disappeared.
Pronounced drop in blood pressure has been reported in post-marketing
surveillance in patients with
pre-existing risk factors (such as underlying cardiac diseases and/or
concomitant treatment with
anti-hypertensive medication).

Características técnicas

Health Products Regulatory Authority
02 March 2020
CRN009N8S
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xatral 10mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg alfuzosin hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet, prolonged release.
Round biconvex three layer tablet: one white layer between two yellow
layers
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy.
Adjunctive therapy with urethral catheterization for Acute Urinary
Retention related to BPH.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Xatral 10mg prolonged release tablets are for oral administration.
Xatral 10mg Prolonged Release Tablets should be swallowed whole.
BPH: The recommended dose is one 10mg tablet once daily to be taken
after a meal.
AUR: One 10mg tablet daily after a meal to be taken from the first day
of catheterisation.
Paediatric population:
Efficacy of Xatral has not been demonstrated in children aged 2 to 16
years (see section 5.1). Therefore, Xatral is not indicated
for use in paediatric population.
4.3 CONTRAINDICATIONS

Hypersensitivity to the alfuzosin or any component.

History of orthostatic hypotension.

Combination with other alpha
1
-blockers.

Hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with all alpha
1
-blockers in some subjects, in particular patients receiving
antihypertensive medications or nitrates. In some
subjects postural hypotension may develop, with or without symptoms
(dizziness, fatigue, sweating) within a few hours
following administration. These effects are usually transient, occur
at the beginning of treatment and do not usually prevent
the continuation of treatment. In such cases, the patient should lie
down until the symptoms have completely disappeared.
Pronounced drop in blood pressure has been reported in post-marketing
surveillance in patients with pre-existing risk fa