GRANPIDAM Film-coated tablet Ref.[27693] Active ingredients: Sildenafil

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ยช planta, 08039 Barcelona, Spain

Product name and form

Granpidam 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

White to off white, round shaped, approximately 6.6 mm in diameter, biconvex, film-coated tablets, debossed with ‘20’ on one side and plain on other side.

Qualitative and quantitative composition

Each film-coated tablet contains 20 mg of sildenafil (as citrate).

Excipient(s) with known effect:

Each tablet also contains 0.2 mg of 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
Croscarmellose sodium
Hypromellose 2910 (E464)
Magnesium stearate

Film coat:

Hypromellose 2910 (E464)
Titanium dioxide (E171)
Lactose monohydrate
Triacetin

Pack sizes and marketing

PVC/Alu blisters packs containing 90 tablets and 300 tablets.

PVC/Alu perforated unit dose blister packs containing 15x1, 90x1 and 300x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ยช planta, 08039 Barcelona, Spain

Marketing authorization dates and numbers

EU/1/16/1137/001
EU/1/16/1137/002
EU/1/16/1137/003
EU/1/16/1137/004
EU/1/16/1137/005

Date of first authorisation: 14th November 2016

Drugs

Drug Countries
GRANPIDAM Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom

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