APO-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: sodium starch glycollate type A; microcrystalline cellulose; lactose monohydrate; pregelatinised maize starch; lauroyl macrogolglycerides; magnesium stearate; 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:

APO-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. APO-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

APO-Finasteride 1
1
APO-FINASTERIDE 1
_Finasteride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about finasteride. 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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
FINASTERIDE IS FOR USE BY MEN ONLY.
Finasteride 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 (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 IT WORKS _
Finasteride specifically lowers the
levels of DHT in the scalp, helping to
reverse the balding process.
Finasteride 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.
In women who were studied,
finasteride 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,

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-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
APO-Finasteride 1 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
THERAPEUTIC INDICATIONS
APO-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.
APO-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
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dosage is one 1mg tablet daily. APO-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
CONTRAINDICATIONS
APO-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
APO-Finasteride 1 is not indicated for use in women or children.
2
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 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 l