PHARMACOR FINASTERIDE 1 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:

Pharmacor Pty Ltd

INN (International Name):

Finasteride

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

126, 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pharmacor Finasteride 1 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. Pharmacor Finasteride 1 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: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-03-26

Patient Information leaflet

Version 4.0
1
PHARMACOR FINASTERIDE 1
Finasteride Tablets 1 mg
CONSUMER MEDICINE INFORMATION
_WHAT IS IN THIS _
_LEAFLET _
This leaflet answers some common
questions
about
Pharmacor
Finasteride 1. 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
Pharmacor
Finasteride
1
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 _
_PHARMACOR _
_FINASTERIDE 1 IS USED FOR _
Pharmacor Finasteride 1 is for use
by men only.
Pharmacor Finasteride 1 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 _
_PHARMACOR _
_FINASTERIDE 1 WORKS _
Pharmacor
Finasteride
1
specifically
lowers
the
levels
of
DHT in the scalp, thus helping to
reverse the balding process.
Pharmacor Finasteride 1 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 Pharmacor
Finasteride 1.
In
women
who
were
studied,
Pharmacor Finasteride 1 was not
effective in the treatment of hair
loss

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – PHARMACOR
FINASTERIDE 1 (FINASTERIDE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Finasteride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Finasteride 1 mg
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pharmacor Finasteride 1 are 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
Pharmacor Finasteride 1 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.
Pharmacor Finasteride 1 is not indicated for use in women (see
sections 4.6 FERTILITY, PREGNANCY AND
LACTATION – USE IN PREGNANCY and 5.1 PHARMACODYNAMIC PROPERTIES –
CLINICAL STUDIES) or
children.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dosage is one 1-mg tablet daily. Pharmacor Finasteride
1 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
Pharmacor Finasteride 1 is contraindicated in the following:
•
Use in women when they are or may potentially be pregnant (see section
4.6 FERTILITY,
PREGNANCY AND LACTATION – USE IN PREGNANCY)
•
Hypersensitivity to any component of this product
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
2
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 prostatic
hyperplasia (BPH), consideration should be given to the fact that, in
older men with BPH, PSA levels
are decreased by appr