APO-SILDENAFIL sildenafil (as citrate) 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sildenafil citrate, Quantity: 140.48 mg (Equivalent: sildenafil, Qty 100 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Sildenafil citrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

1, 4, 12, 8

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 "SIL100" 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:

Registered

Authorization date:

2011-01-12

Patient Information leaflet

APO-SILDENAFIL
_(sildenafil citrate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor.
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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Sildenafil. 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 THIS
MEDICINE
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 THIS MEDICINE IF:
•
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). Comm

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-SILDENAFIL (
SILDENAFIL CITRATE
) FILM COATED
TABLETS
1
NAME OF THE MEDICINE
Sildenafil citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg, 50 mg or 100 mg sildenafil as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
25 MG TABLETS
White to off-white diamond shaped, biconvex, film coated tablets,
engraved “APO” on one side
and “SIL25” on the other side.
50 MG TABLETS
White to off-white diamond shaped, biconvex, film coated tablets,
engraved “APO” on one side
and “SIL50” on the other side.
100 MG TABLETS
White to off-white diamond shaped, biconvex, film coated tablets,
engraved “APO” on one side
and “SIL100” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil is indicated for the treatment of erectile dysfunction in
adult males.
Sildenafil is not indicated for use by women.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Sildenafil tablets are intended for oral administration.
DOSAGE
USE IN ADULTS
The recommended dose is 50 mg taken as needed approximately one hour
before sexual
activity. Based on the efficacy and toleration, the dose may be
increased to 100 mg or
decreased
to
25
mg.
The
maximum
recommended
dose
is
100
mg.
The
maximum
recommended dosing frequency is once per day.
USE IN THE ELDERLY
Since sildenafil clearance is reduced in elderly patients, a first
dose of 25 mg should be
considered. Based on efficacy and toleration, the dose may be
increased to 50 mg and 100
mg.
DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT
The dosing recommendations for USE IN ADULTS should be followed for
patients with mild to
moderate renal impairment (Cl
cr
= 30-80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (Cl
cr
< 30
mL/min) a 25 mg starting dose should be considered. Based on efficacy
and toleration, the
dose may be increased to 50 mg and 100 mg.
DOSAGE ADJUSTMENT IN HEPATIC IMPAIRMENT
Since sildenafil clearance is