Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France
Tadalafil Mylan 2.5 mg film-coated tablets.
Pharmaceutical Form |
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Film-coated tablet. A light yellow, film-coated, round, biconvex tablet (5.1 ± 0.3 mm) debossed with ‘M’ on one side of the tablet and ‘TL over 1’ on the other side. |
Each tablet contains 2.5 mg tadalafil.
Excipient with known effect: Each coated tablet contains 29.74 mg of lactose.
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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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 |
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Tablet core: Lactose, anhydrous Film-coat: Lactose monohydrate |
PVC/PE/PVdC-Alu blisters.
Pack sizes of 28 and 56 tablets.
Not all pack sizes may be marketed.
Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France
EU/1/14/961/008
EU/1/14/961/009
Date of first authorisation: 21 November 2014
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