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

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Azeptil 500 mg capsules.

Pharmaceutical Form

Capsule, hard.

Maroon-white hard gelatin capsules filled with a white powder.

Qualitative and quantitative composition

Each capsule contains 500mg tranexamic acid.

Excipient(s) with known effect: Carmoisine (E122).

For the full list of excipients, see section 6.1.

Active Ingredient

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

Povidone
Croscarmellose sodium
Talc
Magnesium stearate

Capsule shell is gelatin with colorants:

Erythrosine (E127)
Brilliant blue (E133)
Titanium dioxide (E171)
Carmoisine (E122)

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

13426

Date of first authorization: 25.06.1991
Date of latest renewal: 30.07.2013

Drugs

Drug Countries
AZEPTIL Cyprus, Hong Kong
 
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