SILDENAFIL-DRLA Sildenafil (as citrate) 50 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sildenafil citrate

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Sildenafil citrate

Authorization status:

Registered

Patient Information leaflet

Sildenafil‐DRLA CMI v2
Page 1 of 5
CONSUMER MEDICINE INFORMATION
SILDENAFIL‐DRLA
_(sildenafil citrate) _
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
sildenafil.
It does not contain all the
available information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
this medicine 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
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT SILDENAFIL‐DRLA IS
USED FOR
The name of your medicine is
Sildenafil generichealth. It
contains the active ingredient
sildenafil citrate.
Sildenafil belongs to a group of
medicines called
phosphodiesterase type 5
inhibitors.
Sildenafil 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 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 will only work if you
are sexually excited.
It will not increase your sex
drive.
Sildenafil is not for use in
women.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE SILDENAFIL ‐
DRLA
YOU MUST NOT TAKE
SILDENAFIL IF YOU ARE TAKING
NITRATES OR NITRITE
MEDICATIONS.
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 THIS
MEDICINE.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SILDENAFIL 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

Summary of Product characteristics

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SILDENAFIL-DRLA _25, 50 & 100MG FILM COATED TABLETS_PI_V5_ PAGE 1 OF
15
PRODUCT INFORMATION
SILDENAFIL-DRLA FILM COATED TABLET
(sildenafil citrate)
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
.
Molecular weight is
666.7.
Sildenafil citrate has the following structural formula:-
DESCRIPTION
Sildenafil citrate is white to off-white crystalline powder. Its
aqueous solubility is equivalent to 2.6
mg sildenafil per mL at 25°C.
In addition to sildenafil citrate, each Sildenafil-DRLA 25mg, 50mg and
100mg tablet contains the
following
inactive
ingredients:
cellulose-microcrystalline,
calcium
hydrogen
phosphate,
croscarmellose sodium,
hydroxypropylcellulose and
magnesium stearate. The components of coating
system are hypromellose, lactose, glycerol triacetate, titanium
dioxide and indigo carmine CI 73015.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
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.
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SILDENAFIL-DRLA _25, 50 & 100MG FILM COATED TABLETS_PI_V5_ PAGE 2 OF
15
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