Xatral 2.5mg Film-Coated Tablets

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

ALFUZOSIN HYDROCHLORIDE

Fáanlegur frá:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC númer:

G04CA; G04CA01

INN (Alþjóðlegt nafn):

ALFUZOSIN HYDROCHLORIDE

Skammtar:

2.5 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Alpha-adrenoreceptor antagonists; alfuzosin

Leyfisstaða:

Marketed

Leyfisdagur:

1991-03-26

Upplýsingar fylgiseðill

1.
NAME OF THE MEDICINAL PRODUCT
Xatral
2.5mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg alfuzosin hydrochloride.
Excipients: Also contains 61mg Lactose Monohydrate.
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Film-coated Tablet.
White round, film coated tablet engraved on one side with ‘Xatral
2.5’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Xatral 2.5mg Film-coated tablets are for oral administration
Xatral 2.5mg Film-coated tablets should be swallowed whole. The first
dose should be given
just before bedtime.
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.
Adults
The usual dose is one tablet three times daily. The dose may be
increased to a maximum of 4
tablets (10mg) per day depending on the clinical response.
Elderly (over 65 years) and treated hypertensive patients
As a routine precaution when prescribing alfuzosin to elderly patients
(aged over 65 years) and
treated hypertensive patients, the initial dose should be 1 tablet in
the morning and 1 tablet in
the evening.
Renal insufficiency
In patients with renal insufficiency, as a precaution, it is
recommended that the dosing be
started at Xatral 2.5mg twice daily adjusted according to clinical
response.
Hepatic insufficiency
In patients with mild to moderate hepatic insufficiency, it is
recommended that therapy should
commence with a single dose of Xatral 2.5mg per day to be increased to
Xatral 2.5mg twice
daily according to clinical response.
4.3
CONTRAINDICATIONS

Hypersensitivity to the alfuzosin or any component.

History of orthostatic hypotension.

Combination with other alpha
1
- blockers.

Severe hepatic insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Alfuzosin should be given with caution to p

Vara einkenni

Health Products Regulatory Authority
02 March 2020
CRN009N8S
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xatral 2.5mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg alfuzosin hydrochloride.
Excipients: Also contains 61mg Lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-Coated Tablet.
White round, film coated tablet engraved on one side with ‘Xatral
2.5’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Xatral 2.5mg Film-Coated tablets are for oral administration
Xatral 2.5mg Film-Coated tablets should be swallowed whole. The first
dose should be given just before bedtime.
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.
Adults
The usual dose is one tablet three times daily. The dose may be
increased to a maximum of 4 tablets (10mg) per day
depending on the clinical response.
Elderly (over 65 years) and treated hypertensive patients
As a routine precaution when prescribing alfuzosin to elderly patients
(aged over 65 years) and treated hypertensive patients,
the initial dose should be 1 tablet in the morning and 1 tablet in the
evening.
Renal insufficiency
In patients with renal insufficiency, as a precaution, it is
recommended that the dosing be started at Xatral 2.5mg twice daily
adjusted according to clinical response.
Hepatic insufficiency
In patients with mild to moderate hepatic insufficiency, it is
recommended that therapy should commence with a single dose of
Xatral 2.5mg per day to be increased to Xatral 2.5mg twice daily
according to clinical response.
4.3 CONTRAINDICATIONS

Hypersensitivity to the alfusozin or any component.

History of orthostatic hypotension.

Combination with other alpha
1
-blockers.

Severe hepatic i