CAVERTA TABLETS 100 mg

Country: Malaysia

Language: English

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

Active ingredient:

SILDENAFIL CITRATE

Available from:

RANBAXY (MALAYSIA) SDN. BHD.

INN (International Name):

SILDENAFIL CITRATE

Units in package:

10Tablet Tablets; 60Tablet Tablets; 30Tablet Tablets; 100Tablet Tablets

Manufactured by:

RANBAXY (MALAYSIA) SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CAVERTA TABLETS
Sildenafil (100 mg)
page. 1
WHAT IS IN THIS LEAFLET
1.
What
CAVERTA
is used for
2.
How
CAVERTA
works
3.
Before you take
CAVERTA
4.
How to take
CAVERTA
5.
While you are taking it
6.
Side Effects
7.
Storage
and
Disposal
of
CAVERTA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT CAVERTA IS USED FOR
CAVERTA
is used for the treatment
for
adult
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 CAVERTA WORK
CAVERTA
contains
the
active
substance sildenafil, which belongs to
a
group
of
medicines
called
phosphodiesterase type 5 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.
CAVERTA
will
only help you to get an erection if you
are sexually stimulated.
BEFORE YOU TAKE CAVERTA
_ _
_When you must not take it _

If you are allergic (hypersensitive)
to sildenafil or any of the other
ingredients of
CAVERTA
.

If you are suffering with severe
cardiovascular disorders such as
unstable angina or severe cardiac
failure

If
you
are
taking
medicines
containing
nitrates,
nitrites
or
nitric oxide donors.

If you are taking riociguat. This
medicine
is
used
to
treat
pulmonary
arterial
hypertension
(i.e., high blood pressure in the
lungs)
and
chronic
thromboembolic
pulmonary
hypertension
(i.e.,
high
blood
pressure in the lungs caused by
blood clots).

If you have or ever had a sudden
decrease or loss of vision because
of a problem with blood flow to
the nerve in the eye called non-
arteritic anterior ischaemic optic
neuropathy (NAION).

If you have a severe liver problem.

If you have recently had a stroke
or a heart attack, or if you have
low blood pressure.

If you have certain rare inherited
eye
diseases
(such
as
retinitis
pigmentosa).
_Before you start to take it _
Tell your doctor

If you have sick

Summary of Product characteristics

_For the use only of a Registered Medical Practitioner _
CAVERTA TABLETS 50/100 MG
(Sildenafil Tablets)
COMPOSITION
CAVERTA TABLETS 50 MG
Each film-coated tablet contains:
Sildenafil Citrate 70.24 mg equivalent to
Sildenafil....................... 50 mg.
CAVERTA TABLETS 100 MG
Each film-coated tablet contains:
Sildenafil Citrate 140.48 mg equivalent to
Sildenafil....................... 100 mg.
PRODUCT DESCRIPTION
CAVERTA TABLETS 50 MG
Red coloured, rounded triangular shaped, film-coated tablet, with
‘S22’ engraved on one side and
break line on the other side
CAVERTA TABLETS 100 MG
Red coloured, rounded triangular shaped, film-coated tablet, with
‘S23’ engraved on one side and
break line on the other side
DESCRIPTION
CAVERTA TABLETS contain citrate salt of sildenafil, which is a
selective inhibitor of cyclic
guanosine monophosphate (cGMP)-specific phosphodiesterase type 5
(PDE5).
Sildenafil
citrate
is
chemically
designated
as
1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1_H_-_ _
pyrazolo[4,3-_d_]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine
citrate.
Its
molecular
weight is 666.7. Its empirical formula is C
22
H
30
N
6
O
4
S.C
6
H
8
O
7
. It has the following structural
formula:
SILDENAFIL CITRATE
PHARMACOLOGY
•
MECHANISM OF ACTION
The physiologic mechanism of erection of the penis involves release of
nitric oxide (NO) in the
corpus cavernosum during sexual stimulation. NO 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 has no direct
relaxant effect on isolated human corpus cavernosum, but enhances the
effect of nitric oxide (NO)
by inhibiting phosphodiesterase type 5 (PDE5), which is responsible
for degradation of cGMP in
the corpus cavernosum. When sexual stimulation causes local release of
NO, inhibition of PDE5 by
sildenafil causes increased levels of cGMP in the corpus cavernosum,
resulting in smooth muscle
relaxation