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SPEDRA Tablets (2018)

Active ingredients: Avanafil

Product Name and Form

Spedra 50 mg tablets.

Pharmaceutical form

Tablet.

Pale yellow oval tablets, debossed with “50” on one side.

Qualitative and Quantitative Composition

Each tablet contains 50 mg of avanafil.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Avanafil

Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5. When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection.

List of excipients

Mannitol
Fumaric acid
Hydroxypropylcellulose
Hydroxypropylcellulose, low substituted
Calcium carbonate
Magnesium stearate
Yellow iron oxide (E172)

Pack sizes and Marketing

PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Date of first authorisation: 21 June 2013

Marketing authorization number:

EU/1/13/841/001-003