Alfuro 10 mg Depottablett

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

alfuzosinhydroklorid

Dostupné z:

Hexal AG

ATC kód:

G04CA01

INN (Medzinárodný Name):

alfuzosin hydrochloride

Dávkovanie:

10 mg

Forma lieku:

Depottablett

Zloženie:

laktosmonohydrat Hjälpämne; alfuzosinhydroklorid 10 mg Aktiv substans

Trieda:

Apotek

Typ predpisu:

Receptbelagt

Terapeutické oblasti:

Alfuzosin

Prehľad produktov:

Förpacknings: Blister, 50 tabletter; Blister, 30 tabletter; Blister, 60 tabletter; Blister, 60 x 1 tabletter (endos); Blister, 100 tabletter; Blister, 180 tabletter; Blister, 20 tabletter; Blister, 10 tabletter; Blister, 90 tabletter

Stav Autorizácia:

Avregistrerad

Dátum Autorizácia:

2004-06-04

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALFURO 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 Alfuro is and what it is used for
2.
What you need to know before you take Alfuro
3.
How to take Alfuro
4.
Possible side effects
5.
How to store Alfuro
6.
Contents of the pack and other information
1. WHAT ALFURO IS AND WHAT IT IS USED FOR
Alfuro 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 ALFURO
_DO NOT TAKE ALFURO _

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-blockers.
_WARNINGS AND PRECAUTIONS_
Talk to your doctor or pharmacist before taking Alfuro.

if you have severe kidney problems, since the safety of Alfuro has not
been established in these
patients.


Súhrn charakteristických

Produktinformationen för Alfuro 10 mg depottablett, MTnr 19284,
gäller vid det tillfälle då
läkemedlet godkändes. Informationen kommer inte att uppdateras
eftersom läkemedlet inte
marknadsförs i Sverige. Av samma anledning finns inte någon svensk
produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Alfuro 10 mg prolonged-release tablets
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
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.
P
HARMACEUTICAL
F
ORM
Prolonged-release tablet.
White, round, bevelled-edge, uncoated tablets.
4.
C
LINICAL
P
ARTICULARS
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.
_Elderly (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):
Alfuro 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_
Alfuro
given as 10 mg prolonged release t