Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Mysildecard 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet. A white, round, biconvex film-coated tablet (approximately 6.5 mm diameter), debossed with M on one side of the tablet and SL over 20 on the other side. |
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
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 (PH 102) Film coat: Hypromellose 6 mPas |
PVC-Al blister packs containing 90 or 300 film-coated tablets.
PVC-Al blisters unit dose perforated blister pack containing 90 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
EU/1/16/1134/001
EU/1/16/1134/002
EU/1/16/1134/003
Date of first authorisation: 15 September 2016
Date of latest renewal: 16 July 2021
| Drug | Countries | |
|---|---|---|
| MYSILDECARD | Austria, Germany, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania |
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