TRIPAN 5mg Film-coated tablet Ref.[50693] Active ingredients: Tadalafil

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Delorbis Pharmaceuticals ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Product name and form

Tripan 5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Light brown, oblong, biconvex, film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 5 mg tadalafil.

Excipient with known effect: Each coated tablet contains 77 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
Microcrystalline cellulose
Povidone K-30
Poloxamer type 188
Sodium lauryl sulfate
Croscarmellose sodium
Silica colloidal anhydrous
Magnesium stearate

Film-coat:

Polyvinyl alcohol
Macrogol
Talc
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)

Pack sizes and marketing

Aluminium/PVC/PVDC blisters in cartons of 14, 28, 30 and 84 film-coated tablets.

Not all packs sizes may be marketed.

Marketing authorization holder

Delorbis Pharmaceuticals ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Marketing authorization dates and numbers

M.L.: 023089

26/03/2020

Drugs

Drug Countries
TRIPAN Cyprus, Malta

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