Tadalafil STELLA 10mg film-coated tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Tadalafil

Boleh didapati daripada:

STADPHARM SDN. BHD.

INN (Nama Antarabangsa):

Tadalafil

Unit dalam pakej:

2 Tablets

Dikeluarkan oleh:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Risalah maklumat

TADALAFIL STELLA
_Consumer Medication Information Leaflet (RiMUP)_
Active Ingredient/generic name (Strength): Tadalafil (10 mg, 20 mg)
Page 1 of 3
WHAT IS IN THIS LEAFLET
1.
What Tadalafil STELLA is used for
2.
How Tadalafil STELLA works
3.
Before you use Tadalafil STELLA
4.
How to use Tadalafil STELLA
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Tadalafil
STELLA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TADALAFIL STELLA IS USED FOR
Tadalafil STELLA contains the active
substance tadalafil which belongs to a
group
of
medicines
called
phosphodiesterase type 5 inhibitors.
Tadalafil
STELLA
is
a
treatment
of
erectile dysfunction in adult males. In
order
for
tadalafil
to
be
effective,
sexual
stimulation
is
required.
Tadalafil is not indicated for use by
women.
HOW TADALAFIL STELLA WORKS
Following sexual stimulation Tadalafil
STELLA 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
STELLA
will
not
help you if you do not have erectile
dysfunction.
It
is
important
to
note
that
Tadalafil
STELLA 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 TADALAFIL STELLA
_WHEN YOU MUST NOT USE IT _
Do not take the medicine if you:

are allergic to tadalafil or any of
the
other
ingredients
of
this
medicine.

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”). Tadalafil 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 last 90 days.

recently
had a stroke
within the
last 6 months.

have
low
blood
pressure
o

Ciri produk

TADALAFIL STELLA
COMPOSITION
_Each TADALAFIL STELLA 10 MG film-coated tablet contains _10 mg of
tadalafil.
_Each TADALAFIL STELLA 20 MG film-coated tablet contains _20 mg of
tadalafil.
DESCRIPTION
_TADALAFIL STELLA_
_10 MG:_
Yellow, almond-shaped, film - coated tablet, biconvex, engraved with
“T10” on one
side and plain on the other side.
Dimension: About 6.1 mm x 9.6 mm.
Thickness: About 3.75 mm.
_TADALAFIL STELLA 20 MG:_
Yellow, almond-shaped, film - coated tablet, biconvex, engraved with
“T20” on one
side and plain on the other side.
Dimension: About 7.8 mm x 12.6 mm.
Thickness: About 4.80 mm.
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 treatment of erectile
dysfunction 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
th