Leaflet AMIODARONA HAMELN 50mg / ml concentrate for solution for injection / infusion

Indicated for: cardiac arrhythmias

Route of administration: injectable / infusion

Substance: amiodarone (antiarrhythmic)

ATC: C01BD01 (Cardiovascular system | Antiarrhythmics, class I and III | Antiarrhythmics, class III)

Precautions:
Photosensitivity
Photosensitivity

Avoid excessive exposure to sunlight or UV radiation.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Amiodarone is an antiarrhythmic medication used for the treatment and prevention of various types of cardiac arrhythmias, including atrial fibrillation, ventricular tachycardia, and ventricular fibrillation. It works by prolonging the action potential duration of cardiac cells and slowing the conduction of electrical impulses, helping to restore normal heart rhythm.

Amiodarone can be administered orally in tablet form or intravenously in acute cases. The initial dose is usually higher and is gradually reduced to maintain the therapeutic effect.

Common side effects include nausea, vomiting, photosensitivity, skin pigmentation, and thyroid dysfunction (hypothyroidism or hyperthyroidism). In rare cases, severe adverse reactions such as pulmonary toxicity, liver damage, or proarrhythmic effects may occur.

Patients taking amiodarone should undergo regular monitoring for thyroid, liver, and lung function. Additionally, the medication may interact with other drugs, such as anticoagulants or digoxin, requiring dose adjustments. Amiodarone is an effective option for managing severe arrhythmias, but its use requires careful medical supervision.

General data about AMIODARONA HAMELN 50mg / ml

  • Substance: amiodarone
  • Date of latest medicines list: 01-06-2026
  • Product code: W68521002
  • Concentration: 50mg / ml
  • Pharmaceutical form: concentrate for solution for injection / infusion
  • Quantity: 10
  • Product type: Generic medicine
  • Price: 52.37 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: HBM PHARMA S.R.O - SLOVACIA
  • Holder: HAMELN PHARMA GMBH - GERMANIA
  • Number: 10587/2018/02
  • Shelf life: 2 years-after packing for marketing;dupa diluare-it is used immediately

Concentrations available for amiodarone

  • 150mg/3ml
  • 200mg
  • 30mg/ml
  • 50mg/ml