SILDANIL 25 sildenafil (as citrate) 25 mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sildenafil citrate, Quantity: 35.125 mg (Equivalent: sildenafil, Qty 25 mg)

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Sildenafil citrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; hypromellose; calcium hydrogen phosphate; microcrystalline cellulose; magnesium stearate; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

12 Tablets in blister pack, 4 Tablets in blister pack, 8 Tablets in blister pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for the treatment of erectile dysfunction in adult males. Sildenafil Citrate 25 mg tablets is not indicated for use by women.

Product summary:

Visual Identification: Blue, almond shaped, biconvex, film-coated tablets, debossed with '25' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-09-10

Patient Information leaflet

SILDANIL 25, 50, 100
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2012- Page 1 of 4
SILDANIL 25, 50, 100
(SILDENAFIL (AS CITRATE) 25 MG, 50 MG, 100 MG FILM-COATED TABLETS)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sildanil.
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 your taking Sildanil
tablets 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 SILDANIL IS USED FOR
Sildanil tablet 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.
Sildanil tablet 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.
Sildanil tablet will work only if you
are sexually excited.
Sildanil tablet will not increase your
sex drive.
Sildanil tablet is not for use in
women.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE SILDANIL
YOU MUST NOT TAKE
SILDANIL TABLET 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 SILDANIL
TABLET.
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE SILDANIL TABLET 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).
Com

Summary of Product characteristics

Sildanil 25/50/100 (Sildenafil (as citrate) 25 mg, 50 mg, 100 mg
film-coated Tablets) Version 1.0
-2012- Page 1 of 16
PRODUCT INFORMATION
SILDANIL 25, 50, 100
(SILDENAFIL (AS CITRATE) 25 MG, 50 MG, 100 MG FILM-COATED TABLETS)
NAME OF THE MEDICINE
Sildenafil (as citrate)
DESCRIPTION
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
1-[4-ethoxy-3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-
pyrazolo[4,3-d]pyrimidin-5-yl)phenylsulphonyl]-4-methylpiperazine
citrate.
CAS number 171,599-83-0.
The empirical formula for sildenafil citrate is C
22
H
30
N
6
O
4
S.C
6
H
8
0
7
Sildenafil citrate has the following structural formula:-
Sildenafil citrate is an off-white, crystalline powder with a
molecular weight of 666.7. 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:
microcrystalline
cellulose,
calcium
hydrogen
phosphate
anhydrous,
croscarmellose sodium, hypromellose, magnesium stearate. The
film-coating contains
opadry II complete film coating system 31K80865 Blue (ARTG No.107653),
which
consists of hypromellose, titanium dioxide, lactose, glycerol
triacetate and indigo carmine
aluminium lake (E132).
Sildanil 25/50/100 (Sildenafil (as citrate) 25 mg, 50 mg, 100 mg
film-coated Tablets) Version 1.0
-2012- Page 2 of 16
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.
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 musc