SILDACCORD TABLETS 100 mg sildenafil (as citrate) 100 mg film-coated tablets blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

sildenafil citrate, Quantity: 140.5 mg (Equivalent: sildenafil, Qty 100 mg)

MAH:

Accord Healthcare Pty Ltd

INN:

Sildenafil citrate

pharmaceutical_form:

Tablet, film coated

composition:

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

administration_route:

Oral

units_in_package:

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

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

Indicated for the treatment of erectile dysfunction in adult males. Sildenafil Citrate 100 mg tablets is not indicated for use by women.

leaflet_short:

Visual Identification: Blue, almond shaped, biconvex, film-coated tablets, debossed with '100' 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:

Licence status A

authorization_date:

2012-09-10

PIL

SILDACCORD TABLETS
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2012- Page 1 of 4
SILDACCORD TABLETS 25 MG, 50 MG, 100 MG
(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 Sildaccord 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 your taking Sildaccord
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 SILDACCORD TABLETS
IS USED FOR
Sildaccord 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.
Sildaccord 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.
Sildaccord tablet will work only if
you are sexually excited.
Sildaccord tablet will not increase
your sex drive.
Sildaccord tablet is not for use in
women.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
SILDACCORD TABLETS
YOU MUST NOT TAKE
SILDACCORD 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
SILDACCORD TABLET.
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE SILDACCORD TABLET IF:
1. YOU ARE BEING TREATED FOR
ANGINA (CHEST PAIN), OR OTHER
HEART CONDITIONS, WITH CERTAIN
MEDICINES CALLED NITRATES
Nitrate medic

SPC

Sildaccord Tablets (Sildenafil (as citrate) 25 mg, 50 mg, 100 mg
film-coated Tablets)
Version 1.0
-2012- Page 1 of 16
PRODUCT INFORMATION
SILDACCORD TABLETS 25 MG, 50 MG, 100 MG
(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).
Sildaccord Tablets (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), pr