SILDENAFIL GENERICHEALTH Sildenafil (as citrate) 100 mg film coated 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:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Sildenafil citrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

4 Tablet, 12 Tablets, 8 Tablet, 1 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 100 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:

Licence status A

Authorization date:

2012-09-24

Patient Information leaflet

Sildenafil generichealth CMI v2
Page 1 of 5
CONSUMER MEDICINE INFORMATION
SILDENAFIL GENERICHEALTH
_(sildenafil citrate) _
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
sildenafil.
It does not contain all the
available information.
It does not take the place of
talking to your doctor and
pharmacist.
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 SILDENAFIL
GENERICHEALTH IS USED FOR
The name of your medicine is
Sildenafil generichealth. 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 SILDENAFIL
GENERICHEALTH
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 SILDENAFIL IF:
1. YOU ARE BEING TREATED FOR
ANGINA (CHEST PAIN) OR OTHER
HEART CONDITIONS WITH CERTAIN
MEDICINES CALLED NITRATES.
Nitrate medicines include
glycery

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SILDENAFIL GENERICHEALTH
(SILDENAFIL CITRATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Sildenafil citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sildenafil generichealth film-coated tablets contain 25 mg, 50 mg or
100 mg sildenafil (as citrate) per
tablet. Sildenafil citrate is white to off-white crystalline powder.
Its aqueous solubility is equivalent to
2.6 mg sildenafil per mL at 25°C.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 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.
The 50 mg tablets are blue coloured, round film-coated tablet debossed
with ‘SC’ on one side and ‘50’
on other side.
The 100 mg tablets are blue coloured, round film-coated tablet
debossed with ‘SC’ on one side and ‘100’
on 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.
4.2 DOSE 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 (Cl
cr
= 30 to 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
Sin