Propecia

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Finasteride 1mg

Διαθέσιμο από:

Organon (New Zealand) Limited

INN (Διεθνής Όνομα):

Finasteride 1 mg

Δοσολογία:

1 mg

Φαρμακοτεχνική μορφή:

Film coated tablet

Σύνθεση:

Active: Finasteride 1mg Excipient: Docusate sodium Hyprolose Hypromellose Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Microcrystalline cellulose Purified talc Sodium starch glycolate Starch Titanium dioxide

Μονάδες σε πακέτο:

Blister pack, cold-formed aluminium, 28 tablets

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

F.I.S. Fabbrica Italiana Sintetici SpA

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Blister pack, cold-formed aluminium - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, cold-formed aluminium - 84 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, -   - 36 months from date of manufacture stored at or below 30°C - Tablet container, medistick -   - 36 months from date of manufacture stored at or below 30°C

Ημερομηνία της άδειας:

1997-01-14

Φύλλο οδηγιών χρήσης

PROPECIA
®
_finasteride _
1 mg tablet
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 PROPECIA
WHEN YOU MUST NOT

Αρχείο Π.Χ.Π.

NEW ZEALAND DATA SHEET
Page 1
1 PRODUCT NAME
PROPECIA
®
finasteride
1 mg film coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of PROPECIA contains 1 mg of finasteride.
Excipients with known effect: lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
A tan octagonal convex film coated tablet embossed with a P logo on
one side and
PROPECIA on the other.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
PROPECIA is indicated for the treatment of men with male pattern hair
loss (androgenetic
alopecia) to increase hair growth and prevent further hair loss.
•
PROPECIA is NOT indicated for use in women (see section 4.6 Fertility,
pregnancy and
lactation, _Pregnancy_) or children. PROPECIA is not effective in
postmenopausal women
with androgenetic alopecia.
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. Withdrawal from the treatment leads to reversibility
of effect within 12
months.
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, _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
NEW ZEALAND DATA SHEET
Page 2
have benign prostatic hyperplasia (BPH), consideration should be given
to the fact that, in
older men with BPH, PSA levels are decreased by approximatel