FINAPEN 1 mg finasteride 1 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

finasteride, Quantity: 1 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Finasteride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; sodium starch glycollate type A; magnesium stearate; lauroyl macrogolglycerides; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; iron oxide red

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FINAPEN is indicated for the treatment of male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss in men 18 years or older. Efficacy has not been demonstrated in men over the age of 41 years. FINAPEN is not indicated for use in women (see Use in Pregnancy and Clinical Studies) or children.

Product summary:

Visual Identification: Reddish brown, 7 mm, round, biconvex, film-coated tablet, marked 'F1' on one side and plain on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2012-10-17

Patient Information leaflet

FINAPEN CONSUMER MEDICINE INFORMATION
Version 2
-1-
FINAPEN
Finasteride Tablets 1 mg
CONSUMER MEDICINE INFORMATION
_ _
_WHAT IS IN THIS LEAFLET _
This
leaflet
answers
some
common
questions
about
Finapen. 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
Finapen
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 FINAPEN IS USED _
_FOR _
Finapen
is
for
use
by
men
only.
Finapen 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 20s
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
(heredity) 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 FINAPEN WORKS _
Finapen specifically lowers the
levels
of
DHT
in
the
scalp,
thus
helping
to
reverse
the
balding process.
Finapen 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 Finapen.
In women who were studied,
Finapen was not effective in
the
treatment
of
hair
loss
(androgenetic alopecia).
There should be no need to
change your usual hair care
routine
(for
example,
shampooing
or
haircuts)
because
you
are
tak

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – FINAPEN(FINASTERIDE)
FILM COATED TABLET
1
NAME OF THE MEDICINE
Finasteride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains finasteride 1mg
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Finapen comes as a reddish brown, round, biconvex, film-coated
tablets, marked ‘F1’ on one side
and plain on the other
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Finapen is indicated for the treatment of male pattern hair loss
(androgenetic alopecia) to increase
hair growth and prevent further hair loss in men 18 years or older.
Efficacy has not been
demonstrated in men over the age of 41 years.
Finapen is not indicated for use in women (see section 4.6 FERTILITY,
PREGANCY AND LACTATION-
Use in Pregnancy and Clinical Studies) or children.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dosage is one 1-mg tablet daily. Finapen may be taken
with or without food.
In general, daily use for 3 months or more is necessary before
increased hair growth and/or
prevention of further hair loss is observed. Continued use is
recommended to obtain maximum
benefit.
4.3
C
ONTRAINDICATIONS
Finapen is contraindicated in the following: section 4.6 FERTILITY,
PREGNANCY AND LACTATION-
•
Hypersensitivity to any component of this product
•
Finapen is not indicated for use in women or children.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
In clinical studies with finasteride in men 18-41 years of age, the
mean value of serum prostate-
specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5
ng/mL at Month 12. When
finasteride is used for treatment of male pattern hair loss in older
men who also have benign
2
prostatic hyperplasia (BPH), consideration should be given to the fact
that, in older men with BPH,
PSA levels are decreased by approximately 50%.
INCREASED RISK OF HIGH-GRADE PROSTATE CANCER
Men aged 55 and over with a normal digital rectal examination and PSA
≤ 3.0 ng/mL at baseline
taking finas