Alfuzosin hydrochloride Rowex 10 mg prolonged-release tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

ALFUZOSIN HYDROCHLORIDE

Disponible depuis:

Rowex Ltd

Code ATC:

G04CA; G04CA01

DCI (Dénomination commune internationale):

ALFUZOSIN HYDROCHLORIDE

Dosage:

10 milligram(s)

forme pharmaceutique:

Prolonged-release tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Alpha-adrenoreceptor antagonists; alfuzosin

Statut de autorisation:

Not marketed

Date de l'autorisation:

2006-04-28

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALFUZOSIN HYDROCHLORIDE ROWEX 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. 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 Alfuzosin hydrochloride Rowex is and what it is used for
2.
What you need to know before you take Alfuzosin hydrochloride Rowex
3.
How to take Alfuzosin hydrochloride Rowex
4.
Possible side effects
5.
How to store Alfuzosin hydrochloride Rowex
6.
Contents of the pack and other information
1.
WHAT ALFUZOSIN HYDROCHLORIDE ROWEX IS AND WHAT IT IS USED FOR
Alfuzosin hydrochloride Rowex 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 prostatic hyperplasia. 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALFUZOSIN HYDROCHLORIDE ROWEX
DO NOT TAKE ALFUZOSIN HYDROCHLORIDE ROWEX

if you are allergic to alfuzosin, other quinazolines (e.g. terazosin,
doxazosin, prazosin) or any of the
other ingredients of this medicine (listed in section 6).

if you suffer from conditions that cause a marked drop in blood
pressure when standing up.

if you have liver problems.

if you take other medicines that belong to the group of
alpha-blo

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alfuzosin hydrochloride Rowex 10 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg alfuzosin hydrochloride.
Excipients with known effect:
Each tablet contains 8 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round, bevelled-edge, uncoated tablets, approximately 10mm in
diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe functional symptoms of benign
prostatic hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The prolonged-release tablet should be swallowed whole with a
sufficient amount of fluid.
_Adults_
1 prolonged-release tablet 10 mg once daily. The first dose should be
taken at bedtime. The tablet should be taken
immediately after the same meal each day.
_Older people (over 65 years)_
As adults. Pharmacokinetic and clinical safety data demonstrate that
dose reduction is usually not necessary to elderly
patients.
_Reduced renal function_
Mild to moderate renal insufficiency (creatinine clearance
30ml/min):
Dose reduction is usually not necessary (see section 5.2).
Severe renal insufficiency (creatinine clearance < 30ml/min):
Alfuzosin hydrochloride Rowex 10 mg should not be given to patients
with severely impaired renal function as there
are no clinical safety data available for this patient group (see
section 4.4).
_Hepatic insufficiency_
Alfuzosin hydrochloride Rowex given as 10 mg prolonged release tablets
are contraindicated in patients with hepatic
insufficiency. Preparations containing a low dose alfuzosin
hydrochloride might be used in patients with mild to
moderate hepatic insufficiency as instructed in the corresponding
product information.
_Paediatric population_
Efficacy of alfuzosin has not been demonstrated in children aged 2 to
16 years (see section 5.1). Therefore, alfuzosin is
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