PROSCAR 5MG TABLET

Riik: Malaisia

keel: inglise

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

Toimeaine:

FINASTERIDE

Saadav alates:

ORGANON MALAYSIA SDN. BHD.

INN (Rahvusvaheline Nimetus):

FINASTERIDE

Ühikuid pakis:

30Tablet Tablets; 15 Tablet Tablets

Valmistatud:

AIAC International Pharma, LLC

Infovoldik

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PROSCAR
® TABLET
Finasteride (5 mg)
1
Copyright 2023 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What Proscar is taken for
2.
How Proscar works
3.
Before you take Proscar
4.
How to take Proscar
5.
While you are taking Proscar
6.
Side effects
7.
Storage and Disposal of
Proscar
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT PROSCAR IS TAKEN FOR
Why your doctor prescribed
Proscar?
Your doctor has prescribed Proscar
because you have a benign
prostatic hyperplasia or BPH.
Your prostate gland, which is near
your bladder, has become bigger
and is making it more difficult for
you to pass urine.
What is the prostate?
The prostate is a walnut-sized
gland found only in men. It is
located below the bladder and it
surrounds the urethra, a tube that
carries urine from the bladder out
through the tip of the penis (see
diagram). The prostate's main
function is to produce fluid for
semen, the fluid that carries sperm.
HOW PROSCAR WORKS
Proscar is a 5-alpha reductase
inhibitor. It shrinks the enlarged
prostate gland and relieves urinary
symptoms. Proscar will help
reduce the risk of developing a
sudden inability to pass urine
(acute urinary retention) and the
need for surgery.
BEFORE YOU TAKE PROSCAR
What is BPH?
BPH is a benign enlargement of
the prostate gland which is
common in men over 50 years old.
Because the prostate is close to the
bladder and surrounds part of the
urethra, its enlargement may affect
your ability to urinate. You may
experience symptoms such as a
need to urinate often, especially at
night, a feeling that you must
urinate right away, difficulty in
starting to urinate, a weak or
interrupted urinary stream, or a
feeling that you cannot empty your
bladder completely.
In some men, BPH can lead to
serious problems, including urinary
tract infections, a sudden inability
to pass urine, as well as the need
for surgery. For this reason, a man
with symptoms of BPH should see
his physici

Toote omadused

Copyright 2023 Organon group of companies. All rights reserved.
PROSCAR LPC-OG0906-5T-072023-Malaysia
(finasteride)
LOCAL PRODUCT CIRCULAR
TABLETS
PROSCAR
®
(FINASTERIDE)
PROSCAR
®
(finasteride), a synthetic 4-azasteroid compound is a specific
inhibitor of Type II 5
α
-
reductase, an intracellular enzyme which metabolizes testosterone into
the more potent androgen
dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH),
enlargement of the prostate
gland is dependent upon the conversion of testosterone to DHT within
the prostate. PROSCAR is
highly effective in reducing circulating and intraprostatic DHT.
Finasteride has no affinity for the
androgen receptor.
In the PROSCAR Long-Term Efficacy and Safety Study (PLESS), the effect
of therapy with
PROSCAR on BPH-related urologic events (surgical intervention [e.g.,
transurethal resection of
the prostate and prostatectomy] or acute urinary retention requiring
catheterization) was assessed
over a 4-year period in 3016 patients with moderate to severe symptoms
of BPH. In this double-
blind, randomized, placebo-controlled multicenter study, treatment
with PROSCAR reduced the
risk of total urologic events by 51% and was also associated with a
marked and sustained
regression in prostate volume, and a sustained increase in maximum
urinary flow rate and
improvement in symptoms.
INDICATIONS
•
PROSCAR is indicated for the treatment and control of benign prostatic
hyperplasia (BPH) and
for the prevention of urologic events to:
-
Reduce the risk of acute urinary retention.
-
Reduce the risk of surgery including transurethral resection of the
prostate (TURP) and
prostatectomy.
•
PROSCAR causes regression of the enlarged prostate, improves urinary
flow and improves
the symptoms associated with BPH.
Copyright 2023 Organon group of companies. All rights reserved.
Patients with an enlarged prostate are the appropriate candidates for
therapy with PROSCAR.
PROSCAR administered in combination with the alpha-blocker doxazosin
is indicated to reduce
the risk of symptomatic