ADCIRCA Film-coated tablet Ref.[116194] Active ingredients: Tadalafil

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands

Product name and form

ADCIRCA 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Orange and almond shaped film-coated tablets of 12.09 mm x 7.37 mm, marked "4467" on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 20 mg tadalafil.

Excipient with known effect:

Each film-coated tablet contains 233 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient

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:

Lactose monohydrate
Croscarmellose sodium
Hydroxypropylcellulose
Microcrystalline cellulose
Sodium laurilsulfate
Magnesium stearate

Film-coat:

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

Pack sizes and marketing

Aluminium/PVC/PE/PCTFE blisters in cartons of 28 and 56 film-coated tablets.

Not all packs sizes may be marketed.

Marketing authorization holder

Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/08/476/005-006

Date of first authorisation: 1 October 2008
Date of latest renewal: 22 May 2013

Drugs

Drug Countries
ADCIRCA Austria, Australia, Canada, Germany, Estonia, Spain, France, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, United Kingdom, United States

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