SILDENAFIL-ISPL 50 sildenafil (as citrate) 50 mg capsule 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:

iX Biopharma Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; tartrazine; sunset yellow FCF; Gelatin; silicon dioxide; sodium lauryl sulfate

Administration route:

Oral

Units in package:

8, 4, 12

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: SILDENAFIL-ISPL 50 mg capsules are yellow opaque/yellow opaque size 2 hard gelatin capsules with no markings.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-07-31

Summary of Product characteristics

_Sildenafil (as citrate) 25 mg and 50 mg capsules _
_Product Information _
_iX Biopharma Pty Ltd _
Sildenafil capsule PI v2.0 260221
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
SILDENAFIL-ISPL (SILDENAFIL) CAPSULES
1
NAME OF THE MEDICINE
Sildenafil (as citrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Sildenafil-ISPL 25 mg capsules are clear/clear size 2 hard gelatin
capsules with no markings.
Sildenafil-ISPL 50 mg capsules are yellow opaque/yellow opaque size 2
hard gelatin capsules
with no markings.
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 capsules 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
= 30-80 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 reduced in patients with hepatic
impairment (e.g., cirrhosis) a
25 mg starting dose should be considered. Based on efficacy and
toleration, the dose may be
increased to 50 mg and 100 mg.
_Sildenafil (as citrate) 25 mg and 50 mg capsules _
_Product Information _
_iX Biopharma Pty Ltd _
Silde