Xatger 10mg prolonged release tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Alfuzosin hydrochloride

Commercializzato da:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Codice ATC:

G04CA; G04CA01

INN (Nome Internazionale):

Alfuzosin hydrochloride

Dosaggio:

10 milligram(s)

Forma farmaceutica:

Prolonged-release tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Alpha-adrenoreceptor antagonists; alfuzosin

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2006-10-13

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XATGER 10 MG, PROLONGED-RELEASE TABLETS
alfuzosin hydrochloride
For male adults_ _
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 Xatger is and what it is used for
2.
What you need to know before you take Xatger
3.
How to take Xatger
4.
Possible side effects
5.
How to store Xatger
6.
Contents of the pack and other information
1.
WHAT XATGER IS AND WHAT IT IS USED FOR
Xatger contains the active ingredient alfuzosin, which belongs to a
group of
medicines called alpha-adrenoreceptor antagonists or alpha-blockers.
It is used to treat moderate to severe symptoms caused by an enlarged
prostate gland, a
condition that is also called BENIGN (non-cancerous) PROSTATIC
HYPERPLASIA. The
prostate gland lies underneath the bladder. It surrounds the urethra,
the tube that takes
your urine to the outside of the body. If the prostate gets bigger, it
presses on the urethra
making it smaller. Enlarged prostate glands can cause urinary problems
such as frequent
and difficult urination, especially at night.
Alpha-blockers relax the muscles in the prostate and bladder neck.
This allows urine to
flow out of the bladder more easily.
In a few patients with benign prostatic hyperplasia, 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 urine and relieves the
pain. Xatger m

Scheda tecnica

Health Products Regulatory Authority
09 February 2021
CRN009RSY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xatger 10mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 10 mg alfuzosin hydrochloride
Excipient with known effect:
Each tablet contains 7.6 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White, round, bevelled-edge, uncoated prolonged-release tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe symptoms of benign prostatic
hyperplasia (BPH)including adjunctive therapy with urethral
catheterization for acute urinary retention (AUR) related to BPH and
management following catheter removal.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
BPH: One prolonged-release tablet 10 mg dailyto be taken after an
evening meal.
AUR: One 10 mg tablet daily after a meal to be taken from the first
day of catheterization and
continued beyond catheter removal unless there is a relapse of acute
urinary retention or disease progression.
ELDERLY (OVER 65 YEARS) AND PATIENTS WITH RENAL INSUFFICIENCY
Based on pharmacokinetic and clinical safety data, elderly and
patients with renal insufficiency
(creatinine clearance ≥30 ml/min) can be treated with the usual
dose. Due to lacking clinical safety data alfuzosin should not be
given to patients with severe renal impairment (creatinine
clearance <30 ml/min, see section 4.4).
_ _
PATIENTS WITH HEPATIC INSUFFICIENCY
Xatger prolonged-release tablet 10 mg is contraindicated in patients
with hepatic insufficiency (see section 4.3).
Health Products Regulatory Authority
09 February 2021
CRN009RSY
Page 2 of 8
_Paediatric population_
Efficacy of alfuzosin has not been demonstrated in children aged 2 to
16 years (see section 5.1). Therefore, alfuzosin is not
indicated for use in paediatric population.
Method of administration
For oral use.
The prolonged-release tab