Finasteride

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Finasteride 1mg

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

INN (International Name):

Finasteride 1 mg

Dosage:

1 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Finasteride 1mg Excipient: Docusate sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry brown 03A86790 Pregelatinised maize starch Purified water Sodium starch glycolate

Prescription type:

Prescription

Manufactured by:

Hetero Labs Limited

Therapeutic indications:

Pharmacare Finasteride 1 mg film coated tablets: Finasteride is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. Finasteride is not indicated for use in women (see Warnings and Precautions, Pregnancy) or children. Finasteride is not effective in postmenopausal women with androgenetic alopecia.

Product summary:

Package - Contents - Shelf Life: Blister pack, Alu-Alu/PVC/OPA - 30 tablets - 3 years from date of manufacture stored at or below 25°C

Authorization date:

2016-08-15

Patient Information leaflet

FINASTERIDE 1MG FILM-COATED TABLETS (PHARMACARE®)
_finasteride_
1 mg tablet
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Finasteride 1mg
film-coated tablets. 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 film-coated tablets 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 FILM-COATED TABLETS ARE USED FOR
Finasteride 1mg film-coated tablets are for use by men only.
Finasteride 1mg film-coated tablets are 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 FILM-COATED TABLETS WORK
Finasteride 1mg film-coated tablets specifically lower the levels of
DHT in the scalp, thus
helping to reverse the balding process.
Finasteride 1mg film-coated tablets do 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 film-coated tablets.
In women who were studied, Fina

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Finasteride 1mg film-coated tablets (Pharmacare®)
Page 1 of 8
NAME OF MEDICINE
FINASTERIDE 1MG FILM-COATED TABLETS (PHARMACARE®)
_finasteride_
1 mg tablet
PRESENTATION
Brown colour, round, film-coated tablet, debossed with ‘H’ on one
side and ‘36’ on
the other side.
THERAPEUTIC CLASS
Finasteride is a synthetic 4-azasteroid compound that is a specific
inhibitor of Type II
5α-reductase, an intracellular enzyme that metabolises the androgen
testosterone
into dihydrotestosterone (DHT).
INDICATIONS

Finasteride 1mg film-coated tablets are indicated for the treatment of
men with
male pattern hair loss (androgenetic alopecia) to increase hair growth
and
prevent further hair loss.

Finasteride 1mg film-coated tablets are NOT indicated for use in women
(see
Warnings and Precautions, _Pregnancy_) or children. Finasteride 1mg
film-coated
tablets are not effective in postmenopausal women with androgenetic
alopecia.
DOSAGE AND ADMINISTRATION
The recommended dosage is one 1 mg tablet daily. Finasteride 1mg
film-coated
tablets 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. Withdrawal from the treatment leads to
reversibility of effect
within 12 months.
CONTRAINDICATIONS
Finasteride 1mg film-coated tablets is contraindicated in the
following:

Use in women when they are or may potentially be pregnant (See
Warnings and
Precautions, Pregnancy).

Hypersensitivity to any component of this product.

Finasteride 1mg film-coated tablets are not indicated for use in women
or
children.
WARNINGS AND PRECAUTIONS
In clinical studies with Finasteride 1mg film-coated tablets 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
film-coated
tablets are used for treatment of male pattern hair loss in older m