MANFORM ODS-20 Tadalafil Orally Disintegrating Strips 20 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TADALAFIL

Boleh didapati daripada:

MEGA LIFESCIENCES SDN. BHD.

INN (Nama Antarabangsa):

TADALAFIL

Unit dalam pakej:

4 Pieces

Dikeluarkan oleh:

ZIM Laboratories Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
_ _
_ _
1
MANFORM ODS -20
Tadalafil Orally Disintegrating Strips 20mg
WHAT IS IN THIS LEAFLET
1.
What Manform ODS is used for
2.
How Manform ODS works
3.
Before you use Manform ODS
4.
How to use Manform ODS
5.
While
you
are
using
Manform
ODS
6.
Side effects
7.
Storage and disposal of Manform
ODS
8.
Product description
9.
Manufacturer
and
product
registration holder
10.
Date of revision
11.
Serial Number
WHAT MANFORM ODS IS USED FOR
Manform ODS is a treatment for adult
men with erectile dysfunction. This is
when a man cannot get, or keep a hard,
erect penis suitable for sexual activity.
Manform
ODS
has
been
shown
to
significantly
improve
the
ability
of
obtaining a hard erect penis suitable
for sexual activity.
HOW MANFORM ODS WORKS
Manform
ODS
contains
the
active
ingredient tadalafil which belongs to a
group
of
medicines
called
phosphodiesterase
type
5
inhibitors
(PDE 5 inhibitors).
Following
sexual
stimulation
Manform ODS works by helping the
blood vessels in your penis to relax,
allowing the flow of blood into your
penis. The result of this is improved
erectile function. Manform ODS will
not
help
you
if
you
do
not
have
erectile dysfunction.
It is important to note that Manform
ODS
does
not
work
if
there
is
no
sexual
stimulation.
You
and
your
partner will need to engage in foreplay,
just
as
you
would
if you were
not
taking
a
medicine
for
erectile
dysfunction.
BEFORE YOU USE MANFORM ODS
_- When you must not use it _
Do not take Manform ODS if you:
•
are allergic to tadalafil or any of the
other ingredients of this medicine
(see section Product Description).
•
are
taking
any
form
of
organic
nitrate or nitric oxide donors such as
amyl
nitrite.
This
is
a
group
of
medicines
(“nitrates”)
used
in
the
treatment of angina pectoris (“chest
pain”).
Manform
ODS
has
been
shown
to
increase
the
effects
of
these medicines. If you are taking
any form of nitrate or are unsure tell
your doctor.
•
have
serious
heart
disease
or
recently had a heart attack within
the las

Ciri produk

Studies in vitro have shown that tadalafil is a selective inhibitor
of PDE5. PDE5 is an
enzyme found in corpus cavernosum smooth muscle, vascular and visceral
smooth
muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. The
effect of tadalafil is
more potent on PDE5 than on other phosphodiesterases. Tadalafil is >
10,000-fold more
potent for PDE5 than for PDE1, PDE2, and PDE4, enzymes which are found
in the heart,
brain, blood vessels, liver, and other organs. Tadalafil is >
10,000-fold more potent for
PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
This selectivity
for PDE5 over PDE3 is important because PDE3 is an enzyme involved in
cardiac
contractility. Additionally, tadalafil is approximately 700-fold more
potent for PDE5 than
for PDE6, an enzyme which is found in the retina and is responsible
for
phototransduction. Tadalafil is also > 10,000-fold more potent for
PDE5 than for PDE7
through PDE10.
CLINICAL EFFICACY AND SAFETY
In a published study performed in 186 patients (142 tadalafil, 44
placebo) for 12 weeks
with erectile dysfunction secondary to spinal cord injury, tadalafil
significantly improved
the erectile function leading to a mean persubject proportion of
successful attempts in
Published studies conducted on 1054 patients in an at-home setting to
define the period
of responsiveness to tadalafil on demand. Tadalafil demonstrated
statistically significant
improvement in erectile function and the ability to have successful
sexual intercourse up
to 36 hours following dosing, as well as patients' ability to attain
and maintain erections
for successful intercourse compared to placebo as early as 16 minutes
following dosing.
_Erectile dysfunction _
Tadalafil is a selective, reversible inhibitor of cyclic guanosine
monophosphate (cGMP)
specific phosphodiesterase type 5 (PDE5). When sexual stimulation
causes the local
release of nitric oxide, inhibition of PDE5 by tadalafil produces
increased levels of cGMP
in the corpus cavernosum. This results in smooth musc