CHEMMART SILDENAFIL sildenafil (as citrate) 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sildenafil citrate, Quantity: 35.12 mg (Equivalent: sildenafil, Qty 25 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Sildenafil citrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; hyprolose; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; macrogol 8000; magnesium stearate; hypromellose

Administration route:

Oral

Units in package:

4, 8, 12, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sildenafil is indicated for the treatment of erectile dysfunction in adult males. Sildenafil is not indicated for use by women.

Product summary:

Visual Identification: White diamond shaped biconvex, film coated tablets, engraved "APO" on one side and "SIL25" on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2011-01-12

Patient Information leaflet

CHEMMART SILDENAFIL
_Contains the active ingredient sildenafil (as sildenafil citrate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about sildenafil. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Sildenafil. It contains the
active ingredient sildenafil.
It 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.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Sildenafil 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 will work only if you are
sexually excited.
Sildenafil will not increase yo

Summary of Product characteristics

Product Information – Australia
Chemmart Sildenafil 25 mg, 50 mg, 100 mg Tablets
Page 1
CHEMMART SILDENAFIL 25 MG, 50 MG, 100 MG TABLETS
NAME OF THE MEDICINE
Sildenafil citrate
Chemical Name:
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
Structural Formula:
Molecular Formula:
C
22
H
30
N
6
O
4
S.C
6
H
8
0
7
Molecular weight:
666.7
CAS Registry Number:
171,599-83-0
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 an off-white, crystalline powder. Its aqueous
solubility is equivalent to 2.6 mg
sildenafil per mL at 25°C.
Each tablet contains sildenafil citrate as the active ingredient. In
addition, each tablet contains the following
inactive
ingredients:
microcrystalline
cellulose,
croscarmellose
sodium,
colloidal
anhydrous
silica,
magnesium stearate, hydroxypropylcellulose, hypromellose, macrogol
8000 and titanium dioxide.
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Sildenafil tablets are 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 muscle relaxation in the corpus cavernosum
and allowing inflow of
blood.
Sildenafil is a potent and selective inhibitor of cGMP specific
phosphodiesterase type 5 (PDE5) which
is responsible for degradation of cGMP in the corpus cavernosum.
Sildenafil has a peripheral site of
action on erections. Sildenafil has no direct relaxant effect on
isolated human corpus cavernosum but
potently enhance