LEVITRA Film-coated tablet Ref.[50801] Active ingredients: Vardenafil

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Bayer AG, 51368 Leverkusen, Germany

Product name and form

Levitra 5 mg film-coated tablets.

Levitra10 mg film-coated tablets.

Levitra 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Levitra 5 mg film-coated tablets: Orange round tablets marked with the BAYER-cross on one side and “5” on the other side.

Levitra 10 mg film-coated tablets: Orange round tablets marked with the BAYER-cross on one side and “10” on the other side.

Levitra 20 mg film-coated tablets: Orange round tablets marked with the BAYER-cross on one side and “20” on the other side.

Qualitative and quantitative composition

Each tablet of 5 mg film-coated tablets contains 5 mg of vardenafil (as hydrochloride).

Each tablet of 10 mg film-coated tablets contains 10 mg of vardenafil (as hydrochloride).

Each tablet of 20 mg film-coated tablets contains 20 mg of vardenafil (as hydrochloride).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Vardenafil

Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum. Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. In the natural setting, i.e. with sexual stimulation it restores impaired erectile function by increasing blood flow to the penis.

List of Excipients

Tablet core:

Crospovidone
Magnesium stearate
Microcrystalline cellulose
Silica, colloidal anhydrous

Film coat:

Macrogol 400
Hypromellose
Titanium dioxide (E171)
Ferric oxide yellow (E172)
Ferric oxide red (E172)

Pack sizes and marketing

PP/Aluminium foil blisters in cartons of 2, 4, 8, 12 and 20 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

Marketing authorization dates and numbers

EU/1/03/248/001-004, 021
EU/1/03/248/005-008, 022
EU/1/03/248/009-012, 023

Date of first authorisation: 6 March 2003
Date of latest renewal: 6 March 2008

Drugs

Drug Countries
LEVITRA Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Hong Kong, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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