Leaflet VORAMOL 50mg film-coated tablets

Indicated for: fungal infections

Route of administration: oral

Substance: voriconazole (azole antifungal)

ATC: J02AC03 (Antiinfectives for systemic use | Antimycotics for systemic use | Triazole derivatives)

Precautions:
Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Photosensitivity
Photosensitivity

Avoid excessive exposure to sunlight or UV radiation.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

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

This medicine may increase the risk of heart rhythm disturbances.

Voriconazole is an antifungal medication used to treat severe fungal infections, such as invasive aspergillosis, esophageal candidiasis, and other fungal infections caused by Candida or Fusarium species. It belongs to the triazole class and works by inhibiting the synthesis of ergosterol, an essential component of the fungal cell membrane, leading to fungal destruction.

Voriconazole is particularly indicated for immunocompromised patients, such as those with organ transplants, cancer, or other conditions that weaken the immune system. It is available in tablet form, oral suspension, or intravenous injection, and the dosage is adjusted based on the patient’s weight and the severity of the infection.

Common side effects include nausea, vomiting, abdominal pain, skin rashes, visual disturbances (such as blurred vision or light sensitivity), and elevated liver enzymes. Rarely, more serious reactions such as severe hepatotoxicity, allergic reactions, or cardiac arrhythmias may occur.

Treatment with voriconazole requires careful monitoring, including regular liver and kidney function tests. Patients should avoid prolonged sun exposure, as voriconazole can increase skin sensitivity to UV radiation. The medication should be taken as prescribed by a doctor, and dose adjustments should be made cautiously.

General data about VORAMOL 50mg

  • Substance: voriconazole
  • Date of latest medicines list: 01-01-2016
  • Product code: W62032008
  • Concentration: 50mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 56
  • 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: PHARMATHEN INTERNATIONAL S.A. - GRECIA
  • Holder: ALVOGEN IPCO S.AR.L. - LUXEMBURG
  • Number: 8024/2015/08
  • Shelf life: 30 months

Concentrations available for voriconazole

  • 200mg
  • 40mg/ml
  • 50mg