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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

finasteride

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Finasteride

Authorization status:

Registered

Patient Information leaflet

_Finasteride AN 5 mg tablets – Consumer Medicine Information _
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_Doc ID: 61.AN.M.1.0 _
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_Page 1 _
FINASTERIDE AN TABLETS
_Finasteride AN tablets 5 mg _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Finasteride AN 5 mg tablets.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
Finasteride
AN
5
mg
tablets
against the benefits they expect
it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST.
Keep
this
leaflet
with
your
medicine.
You may need to read it again.
WHAT FINASTERIDE AN
5 MG TABLETS ARE USED
FOR
Finasteride AN 5 mg tablets are
for use by men only.
Finasteride AN 5 mg tablets are
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
BHP 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- GA
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-GA
5 also helps reduce the risk of
developing a sudden inability to
pass
urine
(acute
urinary
retentio

Summary of Product characteristics

_Finasteride AN 5 mg tablets Product Information _
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_Amneal Pharma Australia Pty Ltd_
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Finasteride AN.PI v3.0
Page 1 of 13
FINASTERIDE AN
_ _
_(FINASTERIDE 5 MG FILM COATED TABLETS) _
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PRODUCT INFORMATION
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NAME OF THE MEDICINE
The name of the medicine is finasteride.
CHEMICAL NAME:
_N-_(1,1-dimethylethyl)-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide.
MOLECULAR FORMULA: C
23
H
36
N
2
O
2
MOLECULAR WEIGHT: 372.55
CAS REGISTRY NUMBER: _[98319-26-7] _
DESCRIPTION
Finasteride is a white, crystalline solid. It is freely soluble in
chloroform and in lower alcohol
solvents, but is practically insoluble in water.
Finasteride tablets contain the following inactive ingredients:
Lactose, microcrystalline cellulose,
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
_Finasteride AN 5 mg tablets Product Information _
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_Amneal Pharma Australia Pty Ltd_
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Finasteride AN.PI v3.0
Page 2 of 13
gland 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