FINASTERIDE-1MG finasteride 1 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

finasteride

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

Finasteride

Authorization status:

Registered

Patient Information leaflet

FINASTERIDE-1MG
®
_Finasteride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
FINASTERIDE-1MG. 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-1MG 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-1MG IS
USED FOR
FINASTERIDE-1MG is for use by
men only.
FINASTERIDE-1MG 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 FINASTERIDE-1MG_
_WORKS_
FINASTERIDE-1MG specifically
lowers the levels of DHT in the
scalp, thus helping to reverse the
balding process.
FINASTERIDE-1MG 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
FINASTERIDE-1MG. In women
who were studied,
FINASTERIDE-1MG 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)
bec

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
FINASTERIDE-1MG (FINASTERIDE) TABLET
1
NAME OF THE MEDICINE
Finasteride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of FINASTERIDE-1MG contains 1 mg of
finasteride.
List of excipients with known effect: lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
FINASTERIDE-1MG: A tan, octagonal, film-coated convex tablet embossed
with “71” on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FINASTERIDE-1MG 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.
FINASTERIDE-1MG is not indicated for use in women (see SECTION 4.6
FERTILITY, PREGNANCY
AND LACTATION, USE IN PREGNANCY and SECTION 5.1 PHARMACODYNAMIC
PROPERTIES, CLINICAL
TRIALS, STUDIES IN WOMEN) or children.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage is one 1-mg tablet daily. FINASTERIDE-1MG 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
CONTRAINDICATIONS
FINASTERIDE-1MG 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
FINASTERIDE-1MG is not indicated for use in women or children.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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-1MG is used for treatment of male pattern hair
loss in older men
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Page 2 of 13
who also have benign prostatic hyperplasi