Leaflet OMICRAL 100mg capsules

Indicated for: fungal infections

Route of administration: oral

Substance: itraconazole (azole antifungal)

ATC: J02AC02 (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.

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.

Itraconazole is an antifungal medication used for the treatment of systemic and superficial fungal infections, such as aspergillosis, candidiasis, and dermatophytosis. It works by inhibiting the synthesis of ergosterol, an essential component of the fungal cell membrane.

The medication is taken orally, usually once or twice daily, as directed by a doctor. It is important to complete the treatment duration to prevent relapses.

Side effects may include nausea, abdominal pain, headache, or skin rashes. In rare cases, hepatotoxicity or severe allergic reactions may occur.

Itraconazole is not recommended for patients with severe hepatic impairment, congestive heart failure, or hypersensitivity to this medication.

General data about OMICRAL 100mg

  • Substance: itraconazole
  • Date of latest medicines list: 01-06-2026
  • Product code: W67015006
  • Concentration: 100mg
  • Pharmaceutical form: capsules
  • Quantity: 15
  • Product type: Generic medicine
  • Price: 40.70 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: LICONSA S.A. - SPANIA
  • Holder: BAUSCH HEALTH IRELAND LIMITED - IRLANDA
  • Number: 13514/2020/01
  • Shelf life: 2 years

Pharmaceutical forms available for itraconazole

Concentrations available for itraconazole

  • 100mg
  • 10mg/ml

Compensation lists for OMICRAL 100mg Bausch Health

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

40.70 RON

20.35 RON

20.35 RON

G10 (C1) - Leukemias, lymphomas and bone marrow aplasia, tumors

Price

Copayment

Patient

40.70 RON

40.70 RON

0.00 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price

Copayment

Patient

40.70 RON

40.70 RON

0.00 RON

NHP 1.A (C2) - People with HIV/AIDS and post-exposure treatment

Price

Copayment

Patient

40.70 RON

40.70 RON

0.00 RON

NHP 9.4 (C2) - Kidney transplant, combined kidney and pancreas transplant

Price

Copayment

Patient

40.70 RON

40.70 RON

0.00 RON