AZEPTIL Capsule Ref.[28139] Active ingredients: Tranexamic acid

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Azeptil 250mg capsules.

Azeptil 500mg capsules.

Pharmaceutical Form

Capsule, hard.

250mg: Brown-Orange hard gelatin capsules filled with a white powder.

500mg: Maroon-white hard gelatin capsules filled with a white powder.

For oral administration.

Qualitative and quantitative composition

Azeptil 250mg capsules: Each capsule contains 250mg tranexamic acid.

Azeptil 500mg capsules: Each capsule contains 500mg tranexamic acid.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tranexamic acid

Tranexamic acid is an antifibrinolytic that competitively inhibits the activation of plasminogen to plasmin. Tranexamic acid is a competitive inhibitor of plasminogen activation, and at much higher concentrations, a noncompetitive inhibitor of plasmin, i.e., actions similar to aminocaproic acid. Tranexamic acid is about 10 times more potent in vitro than aminocaproic acid. Tranexamic acid binds more strongly than aminocaproic acid to both the strong and weak receptor sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds.

List of Excipients

Azeptil 250mg capsules also contain povidone, croscarmellose sodium, talc, magnesium stearate. Capsule shell is gelatin with colorants erythrosine (E127), sunset yellow (E110), brilliant blue (E133), quinoline yellow (E104) and titanium dioxide (E171).

Azeptil 500mg capsules also contain povidone, croscarmellose sodium, talc, magnesium stearate. Capsule shell is gelatin with colorants erythrosine (E127), brilliant blue (E133), carmoisine (E122) and titanium dioxide (E171).

Pack sizes and marketing

Azeptil is packaged in combination blisters of polyvinylchloride film and aluminum foil. Blisters and leaflet are found in an outer carton.

Azeptil is available in packs of 20, or 50 capsules as well as hospital packs of 500 or 1000 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Azeptil 250mg capsules: 13414
Azeptil 500mg capsules: 13426

Azeptil 250mg capsules: 25.06.1991 / 26.03.2013
Azeptil 500mg capsules: 25.06.1991 / 30.07.2013

Drugs

Drug Countries
AZEPTIL Cyprus, Hong Kong

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