TADAFLO 20mg Tablets

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

Tadalafil

Saatavilla:

GENPHARMA SDN. BHD

INN (Kansainvälinen yleisnimi):

Tadalafil

Kpl paketissa:

8 Tablets; 8 Tablets; 4 Tablets; 4 Tablets

Valmistaja:

Alembic Pharmaceuticals Limited (Formulation Division)

Pakkausseloste

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

Valmisteyhteenveto

1.
NAME OF THE MEDICINAL PRODUCT
TADAFLO 20mg Tablets
2.
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Tadalafil 20mg
3.
PRODUCT DESCRIPTION
TADAFLO 20mg Tablets
Yellow to light yellow, oval shaped, beveled edge, coated tablets
debossed with ‘L339’ on one side and
plain on other side.
4.
DOSAGE FORM
Tablet
5.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Urologicals, Drugs used in erectile
dysfunction, ATC Code: G04BE08.
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.
6.
PHARMACOKINETIC PROPERTIES
Absorption
Tadalafil
is
readily
absorbed
after
oral
administration
and
the
mean
maximum
observed
plasma
concentration (Cmax) is 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 without food. The time of dosing (morning versus evening) had
no clinically relevant effects on
the rate and extent of absorption.
Distribution
The mean volume of distribution is approximately 63 l, indicating that
tadalafil is distributed into tissues.
At therapeutic concentrations, 94 % of tadalafil in plasma is bound to
proteins. Protein binding is not
affected by impaired renal function.
Less than 0.0005 % of the administered dose appeared in the semen of
healthy subjects.
Biotransformation
Tadalafil is predominantly metabolised by the cytochrome P450 (CYP)
3A4 isoform. The major circulating
metabolite is the methylcatechol glucuronide. This metabolite is at
least 13,000-fold less potent than
tadalafil for PDE5. Consequently, it is