Tadacip 20 (Tadalafil Tablets 20mg)

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
22-09-2022
Ciri produk Ciri produk (SPC)
15-06-2021

Bahan aktif:

Tadalafil

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

Tadalafil

Unit dalam pakej:

4 Tablets; 2 x 4 Tablets

Dikeluarkan oleh:

CIPLA LTD

Risalah maklumat

                                TADACIP 20 (TADALAFIL TABLETS 20MG)
Tadalafil 20 mg
CONSUMER MEDICATION INFORMATION (RIMUP)
____________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What TADACIP is used for
2.
How TADACIP works
3.
Before you use TADACIP
4.
How to use TADACIP
5.
While you are using TADACIP
6.
Side effects
7.
Storage and Disposal of TADACIP
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
WHAT TADACIP IS USED FOR
TADACIP 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.
TADACIP
has
been
shown
to
significantly
improve
the
ability
of
obtaining a hard erect penis suitable for
sexual activity.
HOW TADACIP WORKS
TADACIP contains the active substance
tadalafil which belongs to a group of
medicines called phosphodiesterase type
5 inhibitors.
Following sexual stimulation TADACIP
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. TADACIP
will not help you if you do not have
erectile dysfunction. It is important to
note that TADACIP 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 TADACIP
-
_When you must not take it _
Do not take TADACIP 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”).
TADACIP 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

                                
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Ciri produk

                                1
_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for _
_Specialist Use only _
_ _
TADACIP 20
Tadalafil Tablets 20 mg
COMPOSITION
Each film-coated tablet contains:
Tadalafil Ph.Eur. …….20 mg
Colour: Titanium dioxide & Yellow oxide of iron
DOSAGE FORM
Film coated tablets
PRODUCT DESCRIPTION
Yellow coloured, capsule shaped, biconvex film coated tablet with “T
20” debossing on one
side and plain on other side.
PHARMACOLOGY
_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).
_ _
_Erectile dysfunction_
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.
2
_Pulmonary arterial hypertension_
Pulmonary arterial hypertension is associated with impaired release of
nitric oxide by the
vascular endothelium and consequent reduction of cGMP concentrations
within the pulmonary
vascular smooth muscle. PDE5 is the predominant phosphodiesterase in
the pulmonary
vasculature. Inhibition of PDE5 by tadalafil increases the
concentrations of cGMP resulting in
relaxation of the pulmonary vascular smooth muscle cell and
vasodilation of the pulmonary
vascular bed.
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, an
                                
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