Alfu 10 mg Prolonged-release Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Alfuzosin hydrochloride

Disponible desde:

Aurobindo Pharma (Malta) Limited

Código ATC:

G04CA; G04CA01

Designación común internacional (DCI):

Alfuzosin hydrochloride

Dosis:

10 milligram(s)

formulario farmacéutico:

Prolonged-release tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Alpha-adrenoreceptor antagonists; alfuzosin

Estado de Autorización:

Marketed

Fecha de autorización:

2014-08-08

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALFU
10 MG PROLONGED-RELEASE TABLETS
alfuzosin hydrochloride
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 only. 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 Alfu is and what it is used for
2.
What you need to know before you take Alfu
3.
How to take Alfu
4.
Possible side effects
5.
How to store Alfu
6.
Contents of the pack and other information
1.
WHAT ALFU
IS AND WHAT IT IS USED FOR
Alfu belongs to a group of medicines called alpha-1-blockers.
Alfu is used to treat moderate to severe symptoms of Benign Prostate
Hyperplasia. This is a condition
where the prostate gland enlarges (hyperplasia), but the growth in
itself is not cancerous (benign). It
occurs most often in older men.
The prostate gland is situated under the bladder surrounding the
urethra (the tube that takes your urine
to the outside of the body). With age, the prostate gland may grow and
press the urethra making it
smaller. This may cause problems with urination such as frequent
urination and difficulty in passing
urine.
Alfu works by relaxing the prostate gland muscle. This reduces the
narrowing of the urethra and so
makes it easier to pass urine.
In a few patients with benign prostatic hypertrophy, the prostate
gland gets so big that it stops the flow
of urine completely. This is called Acute Urinary Retention.
•
This is very painful and you may need a short stay in hospital.
•
A thin, flexible tube (catheter) is passed into the bladder. This
drains the water and relieves the
pain.
•
During this time, Alfu may be used to help the

Ficha técnica

Health Products Regulatory Authority
09 February 2023
CRN00CR9K
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alfu 10 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 10 mg alfuzosin hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white round (diameter 8.1 mm), biconvex, film-coated
tablets debossed with ‘X’ on one side and ‘47’ on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe functional symptoms of benign prostate
hyperplasia (BPH).
Adjunctive therapy with urethral catheterisation for Acute Urinary
Retention related to BPH.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
BPH: The recommended dose is one 10 mg prolonged-release tablet once
daily to be taken after a meal.
Acute urinary retention:
One 10mg tablet daily after a meal to be taken from the first day of
catheterisation. The treatment should be administered for
3-4 days, 2-3 days during catheterisation and 1 day after catheter
removal. In this indication, No benefit on progression of
acute urinary retention has been established in patients under 65
years of age or if treatment is extended beyond 4 days.
_Elderly (over the age of 65 years) _
The recommended dose is the same as that for adults. Pharmacokinetic
and clinical safety studies have shown that dose
adjustment is not necessary in the case of elderly patients.
_Impaired renal function _
Mild to moderate renal insufficiency (creatinine clearance > 30
ml/min): Dose reduction is usually not necessary (see section
5.2).
_Severe renal insufficiency _
Alfuzosin 10 mg should not be given to patients with severely impaired
renal function (creatinine clearance < 30 ml/min) as
there are no clinical safety data available for this patient group.
_Hepatic insufficiency: _
Alfuzosin, given as 10 mg prolonged-release tablets are
contraindicated in patients with hepatic insu