SILDENAFIL AMNEAL sildenafil (as citrate) 50mg film-coated tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sildenafil citrate

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Sildenafil citrate

Authorization status:

Registered

Patient Information leaflet

Sildenafil AMNEAL CMI v1.0
SILDENAFIL
AMNEAL
FILM COATED
TABLET_ _
CONTAINS SILDENAFIL
(AS CITRATE) _ _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Sildenafil AMNEAL
tablets. It does not
contain all the available
information. It does not
take the place of talking
to your doctor or
pharmacist.
All medicines have risks
and benefits. Your doctor
has weighed the risks of
you taking Sildenafil
AMNEAL against the
benefits they expect it
will have for you.
IT SHOULD BE USED ONLY
UNDER STRICT MEDICAL
SUPERVISION.
IF YOU HAVE ANY
CONCERNS ABOUT USING
THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH
THE MEDICINE.
You may need to read it
again.
WHAT
SILDENAFIL
AMNEAL IS USED
FOR
Sildenafil AMNEAL is
used to treat erectile
dysfunction, more
commonly known as
impotence, in men. This
is when a man cannot get,
or keep, a hard erect penis
suitable for sexual
activity.
Sildenafil AMNEAL
belongs to a group of
medicines called
phosphodiesterase type 5
inhibitors. It works by
relaxing the blood vessels
in your penis when you
are sexually excited. This
allows blood to flow into
your penis, allowing you
to get an erection in the
natural way.
Sildenafil AMNEAL will
work only if you are
sexually excited.
Sildenafil AMNEAL will
not increase your sex
drive.
Sildenafil AMNEAL is
not for use in women.
This medicine is available
only with a doctor's
prescription.
BEFORE YOU
TAKE
SILDENAFIL
AMNEAL
YOU MUST NOT
TAKE SILDENAFIL
AMNEAL IF YOU ARE
TAKING ANY
NITRATE
MEDICATION. IT
MAY LEAD TO A
SEVERE DROP IN
YOUR BLOOD
PRESSURE, WHICH
MAY BE DIFFICULT
TO TREAT.
BECAUSE SEXUAL
ACTIVITY MAY
PLACE A STRAIN ON
YOUR HEART, YOUR
DOCTOR WILL NEED
TO CHECK
WHETHER YOU ARE
FIT ENOUGH TO
TAKE SILDENAFIL
AMNEAL.
_WHEN YOU MUST NOT TAKE _
_IT _
Do not take Sildenafil
AMNEAL if:
1.
you are being treated
for angina (chest pain)
or other heart
conditions with
certain medicines
called nitrates.
Nitrate medicines
include glyceryl
trinitrate (also called
nitroglycerin).
Common tradenam

Summary of Product characteristics

Sildenafil AMNEAL PI v1.0
_ _
_ _
_ _
1
_ _
PRODUCT INFORMATION
SILDENAFIL AMNEAL SILDENAFIL (AS CITRATE) 25, 50 AND 100 MG TABLETS
NAME OF THE MEDICINE
Sildenafil
citrate
is
an
orally
active
selective
inhibitor
of
cGMP
-
specific
PDE5
(phosphodiesterase type 5) which is the predominant PDE isoenzyme in
human corpora
cavernosa.
Sildenafil citrate is
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-
propyl-1,6-dihydro-7
_H_
-pyrazolo[4,3-
_d_
]pyrimidin-7-one
dihydrogen
2-hydroxypropane-
1,2,3-tricarboxylate. CAS number 171599-83-0.
The empirical formula for sildenafil citrate is C
28
H
38
N
6
O
11
S.
Sildenafil citrate has the following structural formula:-
DESCRIPTION
Sildenafil citrate is white or almost white, slightly hygroscopic
crystalline powder
with a molecular weight of 666.7 and a partition coefficient of 0.30.
It is slightly
soluble
in
water
and
in
methanol,
practically
insoluble
in
hexane.
Its
aqueous
solubility is equivalent to 2.6 mg sildenafil per mL at 25
°
C.
In addition to sildenafil citrate, each sildenafil tablet contains the
following inactive
ingredients: lactose, maize starch, sodium starch glycollate Type A,
povidone,
colloidal anhydrous silica, hypromellose, macrogol 400, magnesium
stearate, and
Opadry complete film coating system 06B580001 white (Proprietary
Ingredient No.
109249) and Opadry AMB complete film coating system OY-S-29019 clear
(Proprietary Ingredient No. 4024).
PHARMACOLOGY
Pharmacodynamics
Sildenafil is an oral therapy for erectile dysfunction which restores
impaired erectile
function by increasing blood flow to the penis, resulting in a natural
response to
sexual stimulation.
The physiological mechanism responsible for erection of the penis
involves the
release of nitric oxide (NO) in the corpus cavernosum during sexual
stimulation.
Sildenafil AMNEAL PI v1.0
_ _
_ _
_ _
2
_ _
Nitric oxide then activates the enzyme, guanylate cyclase, which
results in increased
levels
of
cyclic
guanosine
monophosphate
(cGMP),
producing
smooth
muscle
relaxation in the cor