HOVID ERETAF ORODISPERSIBLE FILMS 20MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TADALAFIL

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

TADALAFIL

Unit dalam pakej:

4 x 1 Film Sachets

Dikeluarkan oleh:

ZIM Laboratories Limited

Risalah maklumat

HOVID ERETAF
ORODISPERSIBLE FILMS (ODF)
Tadalafil (10mg, 20mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Hovid Eretaf Orodispersible
Films (ODF) is used for
2.
How Hovid Ereaf ODF works
3.
Before you use Hovid Eretaf ODF
4.
How to use Hovid Eretaf ODF
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Hovid
Eretaf ODF
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HOVID ERETAF ORODISPERSIBLE
FILMS (ODF)
IS USED FOR
Hovid
Eretaf
ODF
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.
Tadalafil has been shown to significantly
improve the ability of obtaining a hard
erect penis suitable for sexual activity.
HOW HOVID ERETAF ODF WORKS
Hovid Eretaf ODF contains the active
ingredient tadalafil which belongs to a
group
of
medicines
called
phosphodiesterase type 5 inhibitors (PDE
5 inhibitors).
Following
sexual
stimulation
tadalafil
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. Tadalafil
will not help you if you do not have
erectile dysfunction. It is important to
note that treatment for the treatment of
erectile
dysfunction
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 HOVID ERETAF ODF
-
_When you must not use it _
Do not take Hovid Eretaf ODF 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”). Hovid Eretaf ODF has been
shown
to
increase
the
effects
of
these medicines. If you are taking
any

Ciri produk

VIERE06-0 (MY)
DESCRIPTION
HOVID ERETAF ORODISPERSIBLE FILMS 10MG
Yellow
colored,
rectangular,
opaque,
non-sticky,
orally
disintegrating strip.
HOVID ERETAF ORODISPERSIBLE FILMS 20MG
Yellow
colored,
rectangular,
opaque,
non-sticky,
orally
disintegrating strip.
COMPOSITION
HOVID ERETAF ORODISPERSIBLE FILMS 10MG
Each orodispersible film contains Tadalafil Ph. Eur. 10mg.
HOVID ERETAF ORODISPERSIBLE FILMS 20MG
Each orodispersible film contains Tadalafil Ph. Eur. 20mg.
PHARMACODYNAMICS
PHARMACOTHERAPEUTIC GROUP: Urologicals, Drugs used in
erectile dysfunction
ATC CODE: G04BE08
MECHANISM OF ACTION
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 muscle relaxation and inflow of blood into
the penile tissues, thereby producing an erection. Tadalafil
has no effect in the absence of sexual stimulation.
PHARMACODYNAMIC EFFECTS
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 EF