TALIS 20 (TADALAFIL TABLETS 20MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TADALAFIL

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

TADALAFIL

Unit dalam pakej:

4 Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

TALIS 20 (TADALAFIL TABLETS 20MG)
Page 1
TALIS 20
(Tadalafil Tablets 20mg)_ _
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1. What TALIS 20 are used for
2. How TALIS 20 work
3. Before you use TALIS 20
4. How to use TALIS 20
5. While you are using it
6. Side effects
7. Storage and Disposal of TALIS 20
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TALIS 20 ARE USED FOR
TALIS 20 contain the active ingredient
tadalafil.
Tadalafil
is
used
to
treat
adult
men
with:

erectile dysfunction, also known as
impotence, in men. This is when a
man cannot get, or maintain, a hard
erect
penis
suitable
for
sexual
activity.
HOW TALIS 20 WORK
ERECTILE DYSFUNCTION
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 tadalafil 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 TALIS 20
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE TALIS 20:

if you are allergic to tadalafil or any
of
the
other
ingredients
of
this
medicine (see product description at
the end of this leaflet). An allergic
reaction
may
include
skin
rash,
itching,
swelling
of
the
face,
lips,
tongue
and
throat
or
difficulty
in
breathing.

if
you
are
currently
taking
any
nitrates
or
amyl
nitrite
(medicines
used to treat chest pain).

if you have serious heart disease or
recently had a heart attack within the
last 90 days.

if you recently had a stroke within
the last 6 months

if you have low blood pressure or
unco

Ciri produk

_For the use of a Registered Medical Practitioner only _
PRESCRIBING INFORMATION
TALIS 20
(TADALAFIL TABLETS USP 20 MG)
COMPOSITION
Each TALIS 20 mg tablet contains 20 mg Tadalafil.
_List of excipients _
Poloxamer (188) (Lutrol F 68), Hydroxy Propyl cellulose, Lactose
Monohydrate, Crosspovidone,
Microcrystalline cellulose, Crosspovidone, Microcrystalline cellulose,
Colloidal Anhydrous Silica,
Magnesium Stearate
DESCRIPTION
1
TALIS 20 is a Yellow colored, oval shaped, biconvex, film coated
tablets plain on both the sides.
TALIS
20
contains
tadalafil
which
is
a
selective,
reversible
inhibitor
of
cyclic
guanosine
monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
1
PHARMACODYNAMICS
_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 (ED) in the absence of
sexual stimulation.
_PHARMACODYNAMIC EFFECTS _
Tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in
the smooth muscle of the
corpus cavernosum, prostate and bladder as well as in vascular and
visceral smooth muscle,
skeletal muscle, platelets, kidney, lung, cerebellum and pancreas. The
effect of tadalafil is more
potent on PDE5 than on other phosphodiesterases.
PHARMACOKINETICS
Tadalafil is readily absorbed after oral administration and the mean
maximum observed plasma
concentration (Cmax) is reported to be achieved at a median time of 2
hours after dosing. Absolute
bioavailability of tadalafil following oral dosing has not been
determined. The rate and extent of
absorption of tadalafil are not influenced by food, thus tadalafil may
be taken with or wit