APX-SILDENAFIL 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, Quantity: 70.24 mg (Equivalent: sildenafil, Qty 50 mg)

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Sildenafil citrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

12 Tablets, 8 Tablet, 1 Tablet, 4 Tablet

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of erectile dysfunction in adult males. It is not indicated for use by women.

Product summary:

Visual Identification: Blue coloured, round film-coated tablet debossed with SC on one side and 50 on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-09-24

Patient Information leaflet

SILDENAFIL APOTEX
_(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
Sildenafil APOTEX. 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).

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SILDENAFIL APOTEX
(SILDENAFIL CITRATE)
1
NAME OF THE MEDICINE
Sildenafil citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg, 50 mg or 100 mg sildenafil (as citrate) per tablet. Sildenafil
citrate is a white to off-white
crystalline powder. Its aqueous solubility is equivalent to 2.6 mg
sildenafil per mL at 25°C.
Ingredients with known effects: lactose.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
The 25 mg tablets are blue coloured, round film-coated tablet debossed
with ‘SC’ on one side and
‘25’ on other side. AUST R 186300.
The 50 mg tablets are blue coloured, round film-coated tablet debossed
with ‘SC’ on one side and
‘50’ on other side. AUST R 186292.
The 100 mg tablets are blue coloured, round film-coated tablet
debossed with ‘SC’ on one side
and ‘100’ on other side. AUST R 186284.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sildenafil is indicated for the treatment of erectile dysfunction in
adult males.
Sildenafil is not indicated for use by women.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Sildenafil tablets are for oral administration.
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 CHILDREN
Sildenafil is not indicated for use in children.
DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT
The dosing recommendations for USE IN ADULTS should be followed for
patients with mild to
moderate renal impairment (Clcr = 30 to 80 mL/min).
1
Since sildenafil clearance is reduced in patients with severe renal
impairment (Clcr <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 reduced in patients with hepatic
impai