RANFUZOSIN MODIFIED RELEASE TABLETS 10 MG

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

ALFUZOSIN HYDROCHLORIDE

متاح من:

RANBAXY (MALAYSIA) SDN. BHD.

INN (الاسم الدولي):

ALFUZOSIN HYDROCHLORIDE

الوحدات في الحزمة:

3x10tablet Tablets

المصنعة من قبل:

RANBAXY (MALAYSIA) SDN. BHD.

نشرة المعلومات

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
RANFUZOSIN TABLETS
Alfuzosin Hydrochloride (10mg)
WHAT IS IN THIS LEAFLET
1.
What
RANFUZOSIN
is used for
2.
How
RANFUZOSIN
works
3.
Before you use
RANFUZOSIN
4.
How to use
RANFUZOSIN
5.
While you are using
RANFUZOSIN
6.
Side effects
7.
Storage and disposal of
RANFUZOSIN
8.
Product description
9.
Manufacturer & Product
registration holder
10.
Date of revision
WHAT RANFUZSOIN IS USED FOR
RANFUZOSIN
is used to treat
symptoms of a medical condition in
men called Benign Prostatic
hypertrophy or BPH.
BPH is a condition where the prostate
gland (which is near your bladder) has
become bigger making it more difficult
for you to pass urine. This can lead to
symptoms such as:

Weak or interrupted stream of
urine

Feeling that you cannot empty
your bladder completely

Delay before you start to pass
urine
RANFUZOSIN
is also used along
with catheter in acute urinary retention
(unability to pass urine) as a symptom
of BPH.
HOW RANFUZOSIN WORKS
RANFUZOSIN
contains active
substance alfuzosin.
Alfuzosin belongs to a group of
medicines known called alpha-1-
blockers.
Alfuzosin works by relaxing the
prostate gland muscle. This reduces the
narrowing of the urethra and so makes
it easier to pass urine.
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RANFUZOSIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is available only with a
doctor’s prescription.
RANFUZOSIN
is available as 10 mg
tablets.
BEFORE YOU USE RANFUZOSIN
-
_When you must not use it _
DO NOT TAKE RANFUZOSIN IF YOU
HAVE AN ALLERGY TO:

any medicine containing
alfuzosin

any of the ingredients of
RANFUZOSIN,
listed at the end
of this leaflet
So

خصائص المنتج

_For the use of registered medical practitioner only _
RANFUZOSIN
(Alfuzosin Hydrochloride Modified Release Tablets 10mg)
COMPOSITION
Each modified release tablet contains:
Alfuzosin Hydrochloride ………………………………….10 mg
INACTIVE INGREDIENTS:
Lactose, Povidone, Aerosil, Purified Talc, Magnesium Stearate,
Hypromellose,
Hydroxy propyl cellulose
PRODUCT DESCRIPTION
White to off-white, uncoated, round, biconvex tablets debossed with
‘RY10’ on
one side of the tablet.
DESCRIPTION
RANFUZOSIN
is
a
modified
release
formulation
that
contains
alfuzosin
hydrochloride
as
active
ingredient,
which
is
a
selective
peripherally
acting
antagonist of post-synaptic alpha1-adrerenoreceptors. Alfuzosin
hydrochloride is
chemically
described
as
(R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)
methylamino]
propyl]
tetrahydro-2-furancarboxamide
hydrochloride.
The
empirical formula of alfuzosin hydrochloride is C
19
H
27
N
5
O
4
•HCl. The molecular
weight of alfuzosin hydrochloride is 425.9.
ALFUZOSIN
PHARMACODYNAMICS & PHARMACOKINETICS
PHARMACODYNAMICS_ _
Alfuzosin is an orally active quinazoline derivative. It is a
selective peripherally
acting antagonist of post-synaptic alpha1-adrerenoreceptors.
Selectivity of alfuzosin for the alpha-1-adrenoreceptors located in
the prostate,
bladder base and prostatic urethra have reported _in vitro_.
Clinical manifestations of Benign Prostatic Hypertrophy (BPH) are
associated
with infra vesical obstruction which is triggered by both anatomical
(static) and
functional (dynamic) factors. The functional component of obstruction
arises from
the
tension
of
prostatic
smooth
muscle
which
is
mediated
by
alpha-
adrenoceptors. Activation of alpha-1-adrenoceptors stimulates smooth
muscle
contraction,
thereby
increasing
the
tone
of
the
prostate,
prostatic
capsule,
prostatic urethra and bladder base, and, consequently, increasing the
resistance
to
bladder
outflow.
This
in
turn
leads
to
outflow
obstruction
and
possible
secondary bladder instability.
Alpha-blockade
decreases
infra
vesic