Leaflet ACENOCUMAROL AUROBINDO 4mg tablets

Indicated for: prevention and treatment of thromboembolism

Route of administration: oral

Substance: acenocoumarol (anticoagulant)

ATC: B01AA07 (Blood and blood forming organs | Antithrombotic agents | Vitamin K antagonists)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Narrow therapeutic index
Narrow therapeutic index

The dose must be followed strictly.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Acenocoumarol is an anticoagulant medication from the coumarin class, used for the prevention and treatment of thrombosis and embolism. It is indicated for conditions such as deep vein thrombosis, pulmonary embolism, atrial fibrillation, and the prevention of thromboembolic complications in patients with prosthetic heart valves.

Acenocoumarol works by inhibiting the synthesis of vitamin K-dependent clotting factors (factors II, VII, IX, and X), thereby reducing the blood's ability to form clots.

The dosage is individually adjusted based on regular monitoring of the INR (International Normalized Ratio) to maintain a balance between preventing clot formation and minimizing the risk of bleeding.

Common side effects include an increased risk of bleeding (e.g., nosebleeds, gum bleeding, or gastrointestinal bleeding), easy bruising, and, in rare cases, skin necrosis. Patients should avoid excessive consumption of foods rich in vitamin K (such as spinach, broccoli, or cabbage), as these can reduce the medication's effectiveness.

Acenocoumarol requires careful monitoring and frequent dose adjustments. Patients should inform their doctor about any other medications or supplements they are taking, as interactions can affect blood clotting.

General data about ACENOCUMAROL AUROBINDO 4mg

  • Substance: acenocoumarol
  • Date of latest medicines list: 01-01-2023
  • Product code: W69283001
  • Concentration: 4mg
  • Pharmaceutical form: tablets
  • Quantity: 20
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: APL SWIFT SERVICES (MALTA) LTD. - MALTA
  • Holder: AUROBINDO PHARMA ROMANIA S.R.L. - ROMANIA
  • Number: 14757/2022/01
  • Shelf life: 3 years

Concentrations available for acenocoumarol

  • 2mg
  • 4mg