Biopharma Sildenafil 50 sildenafil citrate 50 mg sublingual wafers 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:

Wafer

Composition:

Excipient Ingredients: carmellose sodium; mannitol; lactose monohydrate; potato starch; glycine; macrogol 1500; citric acid; quinoline yellow; microcrystalline cellulose; neotame; Flavour

Administration route:

Sublingual

Units in package:

12, 8, 4

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Light yellow to yellow oval disc; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-06-14

Summary of Product characteristics

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1
AUSTRALIAN PRODUCT INFORMATION
BIOPHARMA SILDENAFIL (SILDENAFIL CITRATE) SUBLINGUAL
WAFERS
1
NAME OF THE MEDICINE
Sildenafil (as citrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual wafer contains either 25 or 50mg of sildenafil (as
citrate).
Sildenafil citrate is a white to almost white, crystalline powder. Its
aqueous solubility is equivalent to
2.6 mg sildenafil per mL at 25
°
C.
Excipient with known effect
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Biopharma Sildenafil 25 mg sublingual wafers are light pink to pink
oval discs
Biopharma Sildenafil 50 mg sublingual wafers are light yellow to
yellow oval discs.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Biopharma Sildenafil is indicated for the treatment of erectile
dysfunction in adult males.
Biopharma Sildenafil is not indicated for use by women.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Biopharma Sildenafil wafers are for sublingual administration.
DOSE
_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 _
Biopharma Sildenafil is not indicated for use in children.
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2
METHOD OF ADMINISTRATION
The wafer should only be removed from the blister immediately prior to
administration. The wafer
should be removed from the blister by carefully peeling off the
blister backing and tapping or
pushing the wafer out into dry hands. To prevent crushing, the wafer
must not be removed by
pushing through the blister foil.
To ensure optimal absorption, the mouth should be moist. The patient
should be instructed to rinse
their mouth with a little water prior to administration.
25 mg or 50 mg dose (one wafer): Place the wafer as far back under the
tongue as possible. The
wafer should be kept under the to