ALFUTOR ER TABLETS 10 MG

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

ALFUZOSIN HYDROCHLORIDE

متاح من:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (الاسم الدولي):

ALFUZOSIN HYDROCHLORIDE

الوحدات في الحزمة:

30tablet Tablets

المصنعة من قبل:

TORRENT PHARMACEUTICALS LTD

نشرة المعلومات

ALFUTOR ER TABLETS
_ _
Alfuzosin Hydrochloride (10mg)
_ _
_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Alfutor ER used for.
2.
How Alfutor ER works.
3.
Before you use Alfutor ER.
4.
How to use Alfutor ER.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
Disposal
of
Alfutor
ER.
8.
Product Description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT ALFUTOR ER IS USED FOR
Treatment
for
symptoms
of
noncancerous
enlarged
prostate
gland
known as benign prostatic hypertrophy
(BPH).
Adjuvant treatment to a catheter (thin
tube that can be inserted in the body to
treat
diseases
or
perform
a
surgical
procedure)
in
acute
urinary
retention
related enlarged prostate gland.
HOW ALFUTOR ER WORKS
It
belongs
to
a
group
of
medicines
called
alpha-blockers.
Alfuzosin
Hydrochloride is used to treat moderate
to
severe
symptoms
of
noncancerous
enlarged
prostate
gland.
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. Alfuzosin Hydrochloride
works by relaxing the prostate gland
muscle. This reduces the narrowing of
the urethra and so makes it easier to
pass urine.
BEFORE YOU USE ALFUTOR ER
-
_When you must not use it _
Do not take Alfutor ER:
•
If you are allergic (hypersensitive)
to Alfuzosin Hydrochloride or any
of the other ingredients of Alfutor
ER.
•
Signs
of
an
allergic
reaction
include:
a
rash,
swallowing
or
breathing
problems,
swelling
of
your lips, face, throat or tongue.
•
If
you
are
taking
another
alpha-
blocker.
•
If you have postural hypotension
(occurs
when
a
person's
blood
pressure
falls
when
suddenly
standing up fro

خصائص المنتج

Page 1 of 6
Proposed Prescribing Information
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory
ALFUTOR ER TABLETS 10 MG
ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE TABLETS
863
10 MG
BRAND OR PRODUCT NAME
ALFUTOR ER TABLETS 10 mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each uncoated extended release tablet contains:
Alfuzosin hydrochloride USP ………….10 mg
PRODUCT DESCRIPTION
White to off white, round shape, flat face beveled edge tablets
debossed with '1021' on one side and
'10' on other side.
DOSAGE FORM
Extended release tablet.
PHARMACODYNAMICS / PHARMACOKINETICS
PHARMACODYNAMICS
Pharmacotherapeutic group: alpha-adrenoreceptor antagonists
ATC code: G04CA01
Alfuzosin is an orally active quinazoline derivative. It is a
selective, peripherally acting antagonist of
postsynaptic alpha-1-adrenoceptors.
PHARMACOKINETICS
The b i n d i n g of alfuzosin to plasma proteins is about 90%.
Alfuzosin undergoes extensive
metabolism by the liver, with only 11 % of the parent compound being
excreted unchanged in the
urine. The majority of the metabolites (which are inactive) are
excreted in the faeces (75 to 91 %).
Metabolic interactions: CYP3A4 is the main hepatic enzyme isoform
involved in the metabolism of
alfuzosin.
INDICATION
Treatment of the functional symptoms of benign prostatic hypertrophy
(BPH).
Adjuvant Treatment to a catheter in acute urinary retention related to
benign prostatic hypertrophy.
Page 2 of 6
RECOMMENDED DOSAGE AND MODE OF ADMINISTRATION
_Oral Use:_
The tablet must be swallowed whole with a glass of water. The
recommended dosage is one 10 mg
tablet per day, to be taken immediately after the evening meal.
_Adjuvant Treatment to a catheter in acute urinary retention related
to benign prostatic hypertrophy: _
The recommended dosage is one 10 mg tablet per day, to be taken after
a meal, from the first day of
catheterization onwards. The treatment is administered for 3 to 4
days, i.e. 2 to 3 days while the
catheter is in place and one day after it is removed.
CONTRAINDICATIONS