ANDROZ TABLET 100 MG

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

SILDENAFIL CITRATE

MAH:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN:

SILDENAFIL CITRATE

units_in_package:

4 Tablets; 8 Tablets; 12 Tablets

manufactured_by:

TORRENT PHARMACEUTICAL LIMITED

PIL

ANDROZ TABLET
_ _
Sildenafil Citrate (50 mg, 100 mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Androz used for
2.
How Androz works
3.
Before you use Androz
4.
How to use Androz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Androz
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ANDROZ IS USED FOR
Androz is indicated for the treatment of
erectile
dysfunction,
which
is
the
inability to achieve or maintain a penile
erection
sufficient
for
satisfactory
sexual performance.
In
order
for
Androz
to
be
effective,
sexual stimulation is required.
HOW ANDROZ WORKS
Sidenafil
belongs
to
a
group
of
medicines
called
phosphodiesterase
type 5 inhibitors.
Sildenafil is an oral therapy for erectile
dysfunction. In the natural setting, i.e.
with
sexual
stimulation,
sildenafil
restores impaired erectile function by
increasing blood flow to the penis. It
works by helping to relax
the blood
vessels in your penis, allowing blood to
flow
into
your
penis
when
you
get
sexually excited.
Sildenafil will only help you to get an
erection if you are sexually stimulated.
BEFORE YOU USE ANDROZ
-
_When you must not use it _
Androz
is
contraindicated
in
patients
with a known hypersensitivity to any
component of the tablet.
Androz
was
shown
to
potentiate
the
hypotensive
effects
of
acute
and
chronic nitrates. Do not take Androz if
you
are
using
nitric
oxide
donors,
organic nitrates or organic nitrites in
any
form
either
regularly
or
intermittently.
_ _
_Pregnancy and lactation_
_ _
Androz
is
not
indicated
for
use
by
women. Thus, do not use this medicine
if you are a woman.
-
_Before you start use it _
Talk
to
your
doctor,
pharmacist
or
nurse before taking Androz if any of the
following applies to you:

If you have sickle cell anaemia (an
abnormality
of
red
blood
cells),
leukemia (cancer of blood cells),
multiple myeloma (cancer of bone
marrow).

If
you
have
an
anatomical
deformation of the penis (such as
angulation,
cavern

SPC

FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR HOSPITAL OR A
LABORATORY ONLY
ANDROZ TABLET 50 MG
ANDROZ TABLET 100 MG
(Sildenafil Tablets 50 mg/100 mg)
COMPOSITION
Androz Tablet 50 mg
Each film coated tablet contains:
Sildenafil citrate Ph.Eur. equivalent to Sildenafil
........................... 50 mg
Colours: Lake of Indigo Carmine and Titanium dioxide
Excipients ................ q.s
Androz Tablet 100 mg
Each film coated tablet contains:
Sildenafil citrate Ph.Eur: equivalent to
Sildinafil.......................... 100 mg
Colours: Lake of Indigo Carmine and Titanium dioxide
Excipients ................ q.s.
PHARMACEUTICAL FORM
Film coated Tablets
PRODUCT DESCRIPTION
Androz Tablet 50 mg:
Blue, round biconvex, film coated tablets, debossed with ‘8’
bisect ‘7’ on one side and plain on other
side.
Androz Tablet 100 mg:
Blue, round biconvex, film coated tablets, debossed with ‘8’
bisect ‘8’ on one side and plain on
other side.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Pharmacotherapeutic group: Urologicals; Drugs used in erectile
dysfunction.
ATC Code: G04B E03.
Mechanism of action
The Physiologic mechanism of erection of the penis involves release of
nitric oxide (NO) in the
corpus carvernosum during sexual stimulation.
Nitric oxide then activates the enzyme guanylate cyclase, which
results in increased level of
cyclic guanosine monophophate (cGMP), producing smooth muscle
relaxation in the corpus
carvenosum and allowing inflow of blood.
Sildenafil has no direct relaxant effect on isolated human corpus
carvenosum, but enhances the
effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5
(PDE5), which is responsible
for degradation of cGMP in the corpus carvenosum.
When sexual stimulation causes local release of NO, inhibition of PDE5
by sildenafil causes
increased levels of cGMP in the corpus carvenosum, resulting in smooth
muscle relaxation and
inflow of blood to the carvenosum, Sildenafil at recommended doses has
no effect in the absence
of sexual stimulation.
Sildenafil invitro have sho