EXTEMENT 100mg chewable tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SILDENAFIL CITRATE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

SILDENAFIL CITRATE

Unit dalam pakej:

4 Tablets

Dikeluarkan oleh:

GENEPHARM S.A

Risalah maklumat

EXTEMENT CHEWABLE TABLETS
Sildenafil citrate equivalent to sildenafil (50mg,100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_EXTEMENT chewable tablets _
is used for
2.
How
_EXTEMENT chewable tablets _
works
3.
Before you use
_EXTEMENT _
_chewable tablets _
4.
How to use
_EXTEMENT chewable _
_tablets _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_EXTEMENT chewable tablets_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ EXTEMENT CHEWABLE TABLETS _ IS
USED FOR
Treatment
for
men
with
erectile
dysfunction,
sometimes
known
as
impotence. This is when a man cannot
get, or keep a hard, erect penis suitable
for sexual activity.
HOW
_EXTEMENT _
_CHEWABLE _
_TABLETS _
WORKS
_EXTEMENT _
contains
the
active
substance sildenafil which belongs to a
group
of
medicines
called
phosphodiesterase
type
5
(PDE5)
inhibitors. It works by helping to relax
the blood vessels in your penis, allowing
blood to flow into your penis when you
get
sexually
excited.
_EXTEMENT _
will
only help you to get an erection if you
are sexually stimulated.
_ _
BEFORE YOU USE _ EXTEMENT CHEWABLE _
_TABLETS_
-
_When you must not use it _
•
Hypersensitivity
to
the
active
substance or to any of the excipients
•
Sexual activity is inadvisable.
•
Have
loss
of
vision
in
one
eye
because
of
Non-Arteritic
Anterior
Ischaemic
Optic
Neuropathy
(NAION).
•
Severe
hepatic
impairment,
hypotension, recent history of stroke
or myocardial infarction and known
hereditary
degenerative
retinal
disorders
-
_Before you start to use it _
Tell your healthcare provider about all
the
medicines
you
take,
including
prescription
and
over-the-counter
medicines,
vitamins,
and
herbal
supplements.
-
_Taking other medicines _
Tell your healthcare provider if you take
any of the following:
•
CYP3A4
inhibitor
such
as
Ketoconazole,
erythromycin
and
cimetidine.
•
Medicines
called
HIV
protease
inhibitors,
such
as
ritonavir,
saquinavir
•
Antacid
such
as
magnesium
hydro

Ciri produk

NAME OF THE MEDICINAL PRODUCT
EXTEMENT 50mg chewable tablets
EXTEMENT 100mg chewable tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sildenafil citrate equivalent to 50mg of
sildenafil.
Each tablet contains sildenafil citrate equivalent to 100mg of
sildenafil.
PHARMACEUTICAL FORM
EXTEMENT 50 mg: White, Triangular, biconvex tablets, embossed “50”
on one side
EXTEMENT 100 mg: White, Triangular, biconvex tablets, embossed
“100” on one side
PHARMACODYNAMICS
PHARMACOTHERAPEUTIC GROUP: DRUGS USED IN ERECTILE DYSFUNCTION
ATC-CODE: G04B E03
Sildenafil is an oral therapy for erectile dysfunction. In the natural
setting, i.e. with sexual
stimulation, it restores impaired erectile function by increasing
blood flow to the penis.
The physiological mechanism responsible for erection of the penis
involves the release of nitric oxide
(NO) in the corpus cavernosum during sexual stimulation. Nitric oxide
then activates the enzyme
guanylate cyclase, which results in increased levels of cyclic
guanosine monophosphate (cGMP),
producing smooth muscle relaxation in the corpus cavernosum and
allowing inflow of blood.
Sildenafil is a potent and selective inhibitor of cGMP specific
phosphodiesterase type 5 (PDE5) in the
corpus cavernosum, where PDE5 is responsible for degradation of cGMP.
Sildenafil has a peripheral
site of action on erections. Sildenafil has no direct relaxant effect
on isolated human corpus
cavernosum but potently enhances the relaxant effect of NO on this
tissue. When the NO/cGMP
pathway is activated, as occurs with sexual stimulation, inhibition of
PDE5 by sildenafil results in
increased corpus cavernosum levels of cGMP. Therefore, sexual
stimulation is required in order for
sildenafil to produce its intended beneficial pharmacological effects.
PHARMACOKINETICS
Absorption:
Sildenafil is rapidly absorbed. Maximum observed plasma concentrations
are reached within 30 to
120 minutes (median 60 minutes) of oral dosing in the fasted state.
The mean absolute oral
bioavailability is 41% (range 25