TADACCORD 20 (TADALAFIL TABLETS USP 20 mg)

Land: Maleisië

Taal: Engels

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

Werkstoffen:

Tadalafil

Beschikbaar vanaf:

ACCORD HEALTHCARE SDN.BHD.

INN (Algemene Internationale Benaming):

Tadalafil

Eenheden in pakket:

4 Tablets

Geproduceerd door:

INTAS PHARMACEUTICALS LIMITED

Bijsluiter

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

Productkenmerken

FRONT SIDE
FILE NAME : 10 5241 1 6018654-TADACCORD 20(MALAYSIA)PIL
SIZE
: 160 X 500 (MM)
COLOUR
: PANTONE BLACK
DATE
: 28/07/22
PRESCRIBING INFORMATION: For the use of a Registered Medical
Practitioner or a Hospital or a Laboratory only.
TADACCORD 20
(Tadalafil Tablets USP 20 mg)
1. BRAND OR PRODUCT NAME:
TADACCORD 20
Tadalafil Tablets USP 20 mg
2. NAME AND STRENGTH OF ACTIVE SUBSTANCE(S):
Tadalafil; 20 mg
3. PRODUCT DESCRIPTION:
Yellow, capsule shaped, biconvex, beveled edged, film coated tablets,
debossed with “T 20” on one side and plain on the other side.
4. PHARMACOLOGICAL PROPERTIES:
_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). PDE5 is
an enzyme found in corpus cavernosum smooth muscle, vascular and
visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and
cerebellum.
_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.
_PHARMACOKINETICS PROPERTIES:_
_Absorption_
Tadalafil is readily absorbed after oral administration and the mean
maximum observed plasma concentration (C
max
) 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 TADACCORD 20 may be taken with or without food. The time
of dosing (morning versus evening after a single 10 mg administration)
had no clinically relevant effects on the rate and extent of
absorption.
_Distribution_
The mean volume of distribution is approxima