Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France
Talmanco 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. A white, film-coated, round, biconvex, bevelled edge tablet (approximately 10.7 mm diameter) debossed with ‘M’ on one side of the tablet and ‘TA20’ on the other side. |
Each film-coated tablet contains 20 mg tadalafil.
Excipient with known effect: Each film-coated tablet contains 237.9 mg lactose (234.5 mg as anhydrous and 3.4 mg as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tadalafil |
Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The resulting vascular relaxation increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia are reduced. |
| List of Excipients |
|---|
|
Tablet core: Povidone (K-25) Film-coating: Lactose monohydrate |
PVC/PE/PVdC-Alu blisters in carton containing 28 and 56 film-coated tablets.
PVC/PE/PVdC-Alu perforated unit dose blisters in carton containing 28 × 1 and 56 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France
EU/1/16/1153/001
EU/1/16/1153/002
EU/1/16/1153/003
EU/1/16/1153/004
Date of first authorisation: 09 January 2017
| Drug | Countries | |
|---|---|---|
| TALMANCO | Austria, Germany, Estonia, France, Croatia, Italy, Lithuania, Netherlands, Poland, United Kingdom |
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