PROPECIA TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

FINASTERIDE

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

FINASTERIDE

Unit dalam pakej:

28Tablet Tablets; 28 Tablet Tablets

Dikeluarkan oleh:

AIAC International Pharma, LLC

Risalah maklumat

PROPECIA
® TABLET
Finasteride 1 mg
_Consumer Medication Information Leaflet (RiMUP) _
1
Copyright 2023 Organon group of companies. All rights reserved.
_PROPECIA _
8.
Product description
9.
Product Manufacturer and
Product Registration Holder
10.
Date of Revision
Please read this leaflet carefully
before you start to take your
medicine, even if you have just
refilled your prescription. Some
of the information in the
previous leaflet may have
changed.
Remember that this medicine is
only for you. Only a doctor can
prescribe it for you. Never give
it to anyone else.
WHAT _PROPECIA _IS USED FOR
_PROPECIA _IS FOR USE BY MEN
ONLY.
Your doctor has prescribed
_PROPECIA _
because you have
male pattern hair loss (also
known as androgenetic
alopecia).
_PROPECIA _
increases
hair growth on the scalp and
prevents further hair loss in
men.
_PROPECIA _
is for use in men
only and should
NOT
be used by
women or children.
HOW _PROPECIA _WORKS
_PROPECIA _
blocks an important
enzyme (Type II 5-alpha
reductase) involved in the
regulation of the hair follicle. In
the scalp,
_PROPECIA _
specifically lowers the levels of
DHT, a major cause of male
pattern hair loss. In this way,
_PROPECIA _
helps to reverse the
balding process, leading to
increased hair growth and
prevention of further hair loss.
IN WHOM IS _PROPECIA _
EXPECTED TO WORK?
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).
BEFORE YOU TAKE _PROPECIA _
_ _
_- When you must not take it _
Do not take
_PROPECIA _
if:
•
you are a woman who are or
may potentially be pregnant
(see
USE IN PREGNANCY
).
•
you think you are allergic to
any of its ingredients.
•
you are a woman or child
•
the packaging is torn and
shows signs of tampering
•
the expiry date on the pack
has passed.
WHAT IS IN THIS LEAFLET
What
_PROPECIA _
is used for
How
_PROPECIA _
works
Before you take
_PROPECIA _
How to take
_PROPECIA _
While y

Ciri produk

Copyright 2023 Organon group of companies. All rights reserved.
I. THERAPEUTIC CLASS
II. INDICATIONS
III.
CLINICAL PHARMACOLOGY
IIIA. PHARMACODYNAMIC PROPERTIES
LPC-OG0906-PPC-1T-072023-Malaysia
LOCAL PRODUCT CIRCULAR
PROPECIA
®
(FINASTERIDE)
PROPECIA
®
(finasteride) is a synthetic 4-azasteroid compound that is a specific
inhibitor of Type
II 5α -reductase, an intracellular enzyme that metabolizes the
androgen testosterone into
dihydrotestosterone (DHT).
PROPECIA is indicated for the treatment of men with male pattern hair
loss (androgenetic
alopecia) to increase hair growth and prevent further hair loss.
Safety and efficacy were
demonstrated in men between 18 to 41 years of age with mild to
moderate hair loss of the vertex
and anterior mid-scalp area. Efficacy in bitemporal recession has not
been established.
PROPECIA is
NOT
indicated for use in women (see PREGNANCY) or children. PROPECIA is
not
effective in postmenopausal women with androgenetic alopecia.
Finasteride is a competitive and specific inhibitor of Type II 5α
-reductase. Finasteride has no
affinity
for
the
androgen
receptor
and
has
no
androgenic,
antiandrogenic,
estrogenic,
antiestrogenic, or progestational effects. Inhibition of this enzyme
blocks the peripheral conversion
of testosterone to the androgen dihydrotestosterone (DHT), resulting
in significant decreases in
serum and tissue DHT concentrations. Circulating levels of
testosterone were increased by
approximately 10-15% compared with placebo, yet remained within the
physiologic range.
Copyright 2023 Organon group of companies. All rights reserved.
Finasteride
produces
a
rapid
reduction
in
serum
DHT
concentration,
reaching
significant
suppression within 24 hours of dosing.
Hair follicles contain Type II 5α -reductase. In men with male
pattern hair loss, the balding scalp
contains miniaturized hair follicles and increased amounts of DHT.
Administration of finasteride
decreases scalp and serum DHT concentrations in these men. Men with a
genetic deficiency of
Type II 5α -reductase do not su