FINASTERIDE MYLAN 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:

Accord Healthcare Pty Ltd

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:

FINASTERIDE MYLAN 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 MYLAN 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:

Registered

Authorization date:

2020-05-04

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
FINASTERIDE MYLAN 1
(finasteride) film-coated tablet
What is in this leaflet
This leaflet answers some
common questions about
Finasteride Mylan 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
Finasteride Mylan 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 Finasteride Mylan 1
is used for
Finasteride Mylan 1 is for use by
men only.
Finasteride Mylan 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 Finasteride Mylan 1
works
Finasteride Mylan 1 specifically
lowers the levels of DHT in the
scalp, thus helping to reverse
the balding process.
Finasteride Mylan 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
Finasteride Mylan 1.
In women who were studied,
Finasteride Mylan 1 was not
effective in the treatment of hair
loss (androgenetic alopecia).
There should be no need to
change your usual hai

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – FINASTERIDE MYLAN 1
(finasteride) film-coated tablet
1
NAME OF THE MEDICINE
Finasteride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Finasteride Mylan 1 film-coated tablets contain 1 mg of finasteride.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Finasteride Mylan 1 film-coated tablets are reddish-brown, round,
biconvex, film-coated tablet, marked
‘F1’ on one side and plain on the other.
4
CLINICAL PARTICULARS
4.1 Therapeutic Indications
Finasteride Mylan 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.
Finasteride Mylan 1 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) or children.
4.2 Dose and Method of Administration
The recommended dosage is one 1 mg tablet daily. Finasteride Mylan 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
Finasteride Mylan 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.
Finasteride Mylan 1 v0.2
Page 2 of 15
(finasteride) film-coated tablet
Finasteride Mylan 1 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 is used
for treatmen