Leaflet MEDSAMIC 500mg film-coated tablets


Indicated for: bleeding; coagulation disorders

Route of administration: oral

Substance: tranexamic acid (antifibrinolytic)

ATC: B02AA02 (Blood and blood forming organs | Antifibrinolytics | Amino acids)

Tranexamic acid is an antifibrinolytic agent used to prevent and treat excessive bleeding caused by increased fibrinolysis, a process in which blood clots dissolve too quickly. It works by inhibiting plasminogen, thereby reducing fibrin degradation and helping to stabilize blood clots.

It is used for the treatment of heavy menstrual bleeding (menorrhagia), postoperative hemorrhages, severe trauma, and hemophilia. It is also administered in postpartum hemorrhage to reduce the risk of severe complications.

Tranexamic acid can be given orally, intravenously, or topically, depending on the medical indication. It is preferred for its relatively high safety profile and effectiveness in reducing blood loss without significantly increasing the risk of thrombosis.

Side effects include nausea, diarrhea, headache, and, in rare cases, severe allergic reactions or thrombotic events. It is not recommended for patients with a history of thromboembolism without close medical supervision.

General data about MEDSAMIC 500mg

  • Substance: tranexamic acid
  • Date of last drug list: 01-05-2026
  • Commercial code: W71316002
  • Concentration: 500mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 20
  • Product type: generic
  • Price: 228.59 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: MEDOCHEMIE LTD. (FACTORY AZ) - CIPRU
  • Holder: MEDOCHEMIE LTD. - CIPRU
  • Number: 16185/2025/02
  • Shelf life: 2 years

Concentrations available for tranexamic acid

  • 0.5g/5ml
  • 1000mg
  • 100mg/ml
  • 10mg/ml
  • 500mg
  • 500mg/5ml

Compensation lists for MEDSAMIC 500mg Medochemie

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