FINASTERIDE AN 1 mg finasteride 1 mg film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
finasteride
Available from:
Amneal Pharma Australia Pty Ltd
INN (International Name):
Finasteride
Authorization status:
Registered
Patient Information leaflet
_Finasteride AN 1mg tablets – Consumer Medicine Information _
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_Finasteride AN CMI v2.0 _
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_Page 1 _
FINASTERIDE AN TABLETS
_Finasteride AN tablets 1 mg _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Finasteride AN 1 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
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
1 MG TABLETS ARE USED
FOR
Finasteride AN 1 mg tablets are
for use by men only.
It is used to treat men with male
pattern hair loss to increase hair
growth
on
the
scalp
and
to
prevent further hair loss.
Male
pattern
hair
loss
(also
known as androgenetic alopecia)
is a common condition in which
men experience thinning of the
hair on the scalp.
This often results in a receding
hair line and/or balding on the
top of the head. These changes
typically start to occur in some
men in their 20’s and become
more common with age.
Once
hair
loss
has
occurred
over a long period of time, the
hair may be permanently lost.
Male pattern hair loss is thought
to be caused by a combination
of family history (hereditary) and
production of a particular male
hormone,
called
dihydrotestosterone (DHT). Men
with male pattern hair loss have
more DHT in the balding part of
their scalp than in other parts,
resulting in increased hair loss.
HOW FINASTERIDE AN
WORKS
Finasteride AN 1 m g t a b l e t s
specifically
lowers the levels of
DHT in the scalp, thus helping
to reverse the balding process.
It does not affect hair on other
parts of the body.
Men with mild to moderate, but
not
complete,
hair
loss
can
expect to benefit from the use
of this medicine.
In
women
who
were
studied,
Finasteride
AN
was
not
Read the complete document
Summary of Product characteristics
_Finasteride AN 1 mg tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Finasteride AN PI v3.0
Page 1 of 12
FINASTERIDE AN
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_(FINASTERIDE 1 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 also contain the following inactive ingredients:
Lactose, microcrystalline
cellulose, pregelatinised starch, lauroyl macrogolglycerides, sodium
starch glycollate, magnesium
stearate and Opadry 03F34739 Pink
COMPOSITION
ACTIVE: Finasteride
INACTIVES: Lactose, microcrystalline cellulose, pregelatinised starch,
lauroyl macrogolglycerides,
sodium starch glycollate, magnesium stearate and Opadry 03F34739 Pink.
PHARMACOLOGY
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Finasteride is a competitive and specific inhibitor of Type II
5α-reductase with which it slowly
forms a stable enzyme complex. Turnover from this complex is extremely
slow (t½ ~ 30 days).
Finasteride has no affinity for the androgen receptor and has no
androgenic, antiandrogenic,
oestrogenic, antioestrogenic, or progestational effects. Inhibition of
this enzyme blocks the
_Finasteride AN 1 mg tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Finasteride AN PI v3.0
Page 2 of 12
peripheral conversion of testosterone to the androgen
dihydrotestosterone (DHT), resulting in
significant decreases in serum and tissue DHT concentrations.
Finasteride produces a rapid
reduction in serum DHT concentration, reaching significant suppression
within 24 hours of dosing.
Hair follicles contain Type II 5α-reductase. In men with male pattern
hair loss, the balding scalp
contains miniaturised hair follicles
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