VIAGRA Film-coated tablet Ref.[7448] Active ingredients: Sildenafil

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Product name and form

VIAGRA 25 mg film-coated tablets.

VIAGRA 50 mg film-coated tablets.

VIAGRA 100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

VIAGRA 25 mg tablets: Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 25” on the other.

VIAGRA 50 mg tablets: Blue, rounded, diamond-shaped tablets, marked “PFIZER” on one side and “VGR 50” on the other.

VIAGRA 100 mg tablets: Blue, rounded diamond-shaped tablets, marked “PFIZER” on one side and “VGR 100” on the other.

Qualitative and quantitative composition

Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil.

Excipient with known effect:

VIAGRA 25 mg tablets: Each tablet contains 0.9 mg lactose (as monohydrate).

VIAGRA 50 mg tablets: Each tablet contains 1.7 mg lactose (as monohydrate).

VIAGRA 100 mg tablets: Each tablet contains 3.5 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sildenafil

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

Tablet core:

Microcrystalline cellulose
Calcium hydrogen phosphate (anhydrous)
Croscarmellose sodium
Magnesium stearate

Film coat:

Hypromellose
Titanium dioxide (E171)
Lactose monohydrate
Triacetin
Indigo carmine aluminium lake (E132)

Pack sizes and marketing

VIAGRA 25 mg film-coated tablets: PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.

VIAGRA 50 mg film-coated tablets: PVC/Aluminium blisters in cartons or secondary heat sealed card packaging of 2, 4, 8, 12 or 24 tablets.

VIAGRA 100 mg film-coated tablets: PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Marketing authorization dates and numbers

VIAGRA 25 mg film-coated tablets:

EU/1/98/077/002-004
EU/1/98/077/013

VIAGRA 50 mg film-coated tablets:

EU/1/98/077/006-008
EU/1/98/077/014
EU/1/98/077/016-019
EU/1/98/077/024

VIAGRA 100 mg film-coated tablets:

EU/1/98/077/010-012
EU/1/98/077/015
EU/1/98/077/025

Date of first authorisation: 14 September 1998
Date of latest renewal: 14 September 2008

Drugs

Drug Countries
VIAGRA Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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