CIALIS 5 mg film-coated tablet Ref.[50768] Active ingredients: Tadalafil

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Product name and form

CIALIS 5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Light yellow and almond shaped tablets, marked “C 5” on one side.

Qualitative and quantitative composition

Each tablet contains 5 mg tadalafil.

Excipient with known effect: Each coated tablet contains 121 mg 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. Tadalafil has no effect in the absence of sexual stimulation.
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),
talc.

Pack sizes and marketing

Aluminium/PVC blisters in cartons of 14, 28 or 84 film-coated tablets.

Not all packs sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/02/237/007-008, 010

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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