LIFANED Film-coated tablet Ref.[115341] Active ingredients: Sildenafil

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: Unichem SA (Pty) Ltd, San Domenico, Ground Floor, Unit G4, 10 Church Street, Durbanville, 7551 Cape Town, Tel: 021 531 0436

Product name and form

LIFANED 25 mg film-coated tablets.

LIFANED 50 mg film-coated tablets.

LIFANED 100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

LIFANED 25: Blue coloured, diamond shaped, biconvex, film-coated tablets with “U” debossed on one side and “25” debossed on other side.

LIFANED 50: Blue coloured, diamond shaped, biconvex, film-coated tablets with “U” debossed on one side and “50” debossed on other side.

LIFANED 100: Blue coloured, diamond shaped, biconvex, film-coated tablets with “U” debossed on one side and “100” debossed on other side.

Qualitative and quantitative composition

LIFANED 25: Each film-coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.

LIFANED 50: Each film-coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.

LIFANED 100: Each film-coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.

Excipients with known effect:

Contains sugar.

LIFANED 25: Each tablet contains 67,2 mg lactose monohydrate.

LIFANED 50: Each tablet contains 134,5 mg lactose monohydrate.

LIFANED 100: Each tablet contains 269 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient

Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP. Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.

List of Excipients

Core tablet:

Colloidal silica, anhydrous
Lactose monohydrate
Magnesium stearate (E572)
Maize starch
Povidone
Sodium starch glycolate

Film-coating:

Hypromellose (E464)
Macrogol 400

Opadry 06B50566 blue:

FD&C Blue indigo carmine (colourant) (E132)
Hypromellose (E464)
Macrogol 400
Sodium laurilsulfate
Titanium dioxide (E171)

Opadry OY-S-29019:

Hypromellose (E464)
Macrogol 6 000

Pack sizes and marketing

Clear PVC/Aluminium blister strips placed in an outer carton.

Pack size: 2, 4, 8 or 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Unichem SA (Pty) Ltd, San Domenico, Ground Floor, Unit G4, 10 Church Street, Durbanville, 7551 Cape Town, Tel: 021 531 0436

Marketing authorization dates and numbers

LIFANED 25: 50/7.1.5/0061
LIFANED 50: 50/7.1.5/0062
LIFANED 100: 50/7.1.5/0063

28 February 2022

Drugs

Drug Countries
LIFANED South Africa

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