MEDSAMIC 500mg film-coated tablets medication leaflet

B02AA02 tranexamic acid • 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: W71316001

Concentration: 500mg

Pharmaceutical form: film-coated tablets

Quantity: 10

Product type: generic

Price: 170.09 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: 16185/2025/01

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

NHP 9.1 (C2) - Spinal cord transplant

Price

Copayment

Patient

170.09 RON

137.15 RON

32.94 RON

NHP 9.3 (C2) - Liver Transplant

Price

Copayment

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170.09 RON

137.15 RON

32.94 RON

NHP 9.6 (C2) - Lung transplant

Price

Copayment

Patient

170.09 RON

137.15 RON

32.94 RON