TADALAFIL MYLAN Film-coated tablet Ref.[7110] Active ingredients: Tadalafil

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France

Product name and form

Tadalafil Mylan 2.5 mg film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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
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. Tadalafil has no effect in the absence of sexual stimulation.

List of Excipients

Tablet core:

Lactose, anhydrous
Poloxamer 188
Cellulose, microcrystalline (pH101)
Povidone (K-25)
Croscarmellose sodium
Magnesium stearate
Sodium laurilsulfate
Silica, colloidal anhydrous

Film-coat:

Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Iron oxide yellow (E172)
Triacetin

Pack sizes and marketing

PVC/PE/PVdC-Alu blisters.

Pack sizes of 28 and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France

Marketing authorization dates and numbers

EU/1/14/961/008
EU/1/14/961/009

Date of first authorisation: 21 November 2014

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