PROPECIA Finasteride 1.0mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

finasteride, Quantity: 1 mg

Tilgjengelig fra:

ORGANON PHARMA PTY LTD

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; pregelatinised maize starch; docusate sodium; titanium dioxide; hypromellose; hyprolose; purified talc; iron oxide yellow; iron oxide red

Administreringsrute:

Oral

Enheter i pakken:

28 tablets (Al/Al), 7 tablets (Al/Al), 84 tablets (Al/Al)

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

PROPECIA 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.

Produkt oppsummering:

Visual Identification: Tan, octagonal, film coated convex tablet 'P' logo on one side and "PROPECIA" on the other side (not scored).; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

1998-06-26

Informasjon til brukeren

PROPECIA
®
_Finasteride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROPECIA. 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 PROPECIA
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 PROPECIA IS
USED FOR
PROPECIA is for use by men only.
PROPECIA 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 PROPECIA WORKS_
PROPECIA specifically lowers the
levels of DHT in the scalp, thus
helping to reverse the balding
process.
PROPECIA 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 PROPECIA.
In women who were studied,
PROPECIA 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 taking PROPECIA.
PROPECIA is not addictive.
BEFORE YOU TAKE
PROPEC

Preparatomtale

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AUSTRALIAN PRODUCT INFORMATION
PROPECIA
®
(FINASTERIDE) TABLETS
NAME OF THE MEDICINE
Finasteride
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of PROPECIA 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.
PHARMACEUTICAL FORM
PROPECIA 1 mg: A tan, octagonal, film-coated convex tablet embossed
“P” logo on one side
and “PROPECIA” on the other side.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROPECIA 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.
PROPECIA is NOT indicated for use in women (see SECTION 4.6 FERTILITY,
PREGNANCY AND
LACTATION, USE IN PREGNANCY; SECTION 5.1 PHARMACODYNAMIC PROPERTIES,
CLINICAL TRIALS)
or children.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage is one 1-mg tablet daily. PROPECIA 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
PROPECIA 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
PROPECIA is not indicated for use in women or children.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In clinical studies with PROPECIA 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 PROPECIA is used for treatment of male pattern hair loss in
older men who also
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have benign prostatic hyperplasia (BPH), consideration should be given
to the fact that, i