Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
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. |
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 Film coat: Hypromellose 2910 (E464) |
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.
Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
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
| Drug | Countries | |
|---|---|---|
| GRANPIDAM | Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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