FINASTERIDE RBX 5 finasteride 5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

finasteride

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Finasteride

Authorization status:

Registered

Patient Information leaflet

FINASTERIDE RBX 5
CONSUMER MEDICINE INFORMATION
Version 2
- 1 -
FINASTERIDE RBX 5
Finasteride Tablets 5 mg
CONSUMER MEDICINE INFORMATION
_WHAT IS IN THIS _
_LEAFLET _
This
leaflet
answers
some
common
questions
about
Finasteride RBX 5. It does not
contain
all
the
available
information.
It does not take the place of
talking
to
your
doctor
or
pharmacist.
All medicines have risks and
benefits.
Your
doctor
has
weighed
the
risks
of
you
taking
Finasteride
RBX
5
against
the
benefits
they
expect it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
_WHAT FINASTERIDE RBX _
_5 IS USED FOR _
Finasteride RBX 5 is for use
by men only.
Finasteride RBX 5 is used to
treat
a
medical
condition
in
men
called
benign
prostatic
hyperplasia or BPH. BPH is a
condition where your 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
•
A delay before you start to
pass urine
•
Needing to pass urine often,
especially at night
•
Feeling that you must pass
urine right away
BPH occurs only in men and is
common over the age of 50
years. In some men, BPH can
lead
to
serious
problems,
including
urinary
tract
infections
and
the
sudden
inability to pass urine at all.
BPH can also lead to the need
for
surgery
such
as
procedures
to
improve
the
flow of urine.
The
prostate
gland
takes
years to grow. Therefore, the
symptoms of BPH take a long
time
to
develop.
Finasteride
RBX
5
works
by
slowly
reducing
the
size
of
your
prostate gland. This may lead
to
gradual
improvement
in
your
urine
flow
and
other
symptoms
over
several
months.
Finasteride
RBX
5
also helps reduce the risk of
developing a sudden inability
to
pass
urine
(acute
urinary
retention)
and
the
need
for
surgery.
This
may
happen
whether or not you notice any
improvement
or
change
in
your s

Summary of Product characteristics

Product Information:
Finasteride RBX 5 (Finasteride Film-coated Tablets 5 mg) Ver 2
2011
- 1 -
PRODUCT INFORMATION
FINASTERIDE RBX 5
(FINASTERIDE FILM-COATED TABLETS 5 MG)
NAME OF THE MEDICINE
Finasteride
is
described
chemically
as:
_N-_(1,1-dimethylethyl)-3-oxo-4-aza-5α-androst-1-ene-17β-
carboxamide.
The CAS No. is 98319-26-7.
The empirical formula is C
23
H
36
N
2
O
2
and the molecular weight is 372.55. The structural formula is:
DESCRIPTION
Finasteride is a white, crystalline solid. It is freely soluble in
chloroform and in lower alcohol solvents,
but is practically insoluble in water.
COMPOSITION
ACTIVE: Finasteride
INACTIVES:
Lactose,
cellulose
microcrystalline,
pregelatinised
starch,
lauroyl
macrogolglycerides,
sodium starch glycollate, magnesium stearate and Opadry 03F20404 Blue.
PHARMACOLOGY
MECHANISM OF ACTION
Finasteride is a synthetic 4-azasteroid compound, is a specific
inhibitor of Type II 5α-reductase, an
intracellular
enzyme
which
metabolises
testosterone
into
the
more
potent
androgen
dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH),
enlargement of the prostate gland
is dependent upon the conversion of testosterone to DHT within the
prostate. Finasteride is highly
effective in reducing circulating and intraprostatic DHT. Finasteride
has no affinity for the androgen
receptor.
CLINICAL PHARMACOLOGY
Benign prostatic hyperplasia (BPH) occurs in the majority of men over
the age of 50 and its
prevalence increases with age. Epidemiologic studies suggest that
enlargement of the prostate gland
Product Information:
Finasteride RBX 5 (Finasteride Film-coated Tablets 5 mg) Ver 2
2011
- 2 -
is associated with a 3-fold increase in the risk of acute urinary
retention and prostate surgery. Men
with enlarged prostates are also 3 times more likely to have moderate
to severe urinary symptoms or a
decrease in urinary flow than men with smaller prostates.
The development and enlargement of the prostate gland and subsequent
BPH is dependent upon the
conversion of testosterone to the potent androgen,