ALFU 10 Milligram Tablet Prolonged Release

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

ALFUZOSIN HYDROCHLORIDE

Saatavilla:

Milpharm Limited

ATC-koodi:

G04CA01

INN (Kansainvälinen yleisnimi):

ALFUZOSIN HYDROCHLORIDE

Annos:

10 Milligram

Lääkemuoto:

Tablet Prolonged Release

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Alpha-adrenoreceptor antagonists

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-08-08

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALFU
10 MG PROLONGED-RELEASE TABLETS
alfuzosine 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALFU
DO NOT TAKE ALFU
-
if you are allergic to alfuzosine or the other ingredients of this
medicine (listed in section 6).
Symptoms of an allergic reaction include: a rash, swelling of your
lips, throat, or tongue,
difficulty in swallowing or breathing.
-
If you are allergic (hypersensitive) to alfuzosin-equivalent
substances (such as terazosin,
doxazos

Valmisteyhteenveto

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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral Use
The prolonged-release tablet should be taken whole with sufficient
amount of fluid (e.g. a glass of water). The
prolonged-release tablets must not be crushed, chewed or divided (see
section 4.4).
The first dose should be taken at bedtime. The prolonged-release
tablet 10 mg should be taken immediately after the
same meal each day.
_Adults:_
The recommended dose is one 10 mg prolonged-release tablet daily.
_Elderly patients (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 (see section 4.4).
_Hepatic insufficiency:_
Alfuzosin, given as 10 mg prolonged-release tablets are
contraindicated in patients with hepatic insufficiency.
Preparations containing a low dose of alfuzosin hydrochloride might be
used in patients with mild to moderate hepatic
insufficiency as instructed in the corresponding product information.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A