CIALIS 2.5 mg Film-coated tablet Ref.[50767] Active ingredients: Tadalafil

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Product name and form

CIALIS 2.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Light orange-yellow and almond shaped tablets, marked “C 2 ½” on one side.

Qualitative and quantitative composition

Each tablet contains 2.5 mg tadalafil.

Excipient with known effect: Each coated tablet contains 87 mg of lactose (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:<//u>

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 blisters in cartons of 28 film-coated tablets.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/02/237/006

Date of first authorisation: 12 November 2002
Date of last renewal: 12 November 2012

Drugs

Drug Countries
CIALIS Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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