Leaflet ORUNGAL 100mg capsules

Product code:
W03837002
Quantity:
15
Indicated for:
fungal infections
Route of administration:
oral
Substance:
itraconazole (azole antifungal)
ATC
J02AC02 — Antiinfectives for systemic use | Antimycotics for systemic use | Antimycotics for systemic use | Triazole derivatives

Precautions:

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

This medicine may have important interactions with other medicines.

Pregnancy warning

Use during pregnancy only on medical advice.

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 ORUNGAL 100mg

Substance:
itraconazole
Date of latest medicines list:
01-06-2026
Product code:
W03837002
Concentration:
100mg
Pharmaceutical form:
capsules
Quantity:
15
Product type:
Original
Price:
42.18 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
JANSSEN-CILAG SPA - ITALIA
Holder:
JANSSEN PHARMACEUTICA N.V. - BELGIA
Number:
11593/2019/02
Shelf life:
3 years

Pharmaceutical forms available for itraconazole

Concentrations available for itraconazole

  • 100mg
  • 10mg/ml

Compensation lists for ORUNGAL 100mg Janssen

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

Price
42.18 RON
Copayment
21.09 RON
Patient
21.09 RON

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

Price
42.18 RON
Copayment
42.18 RON
Patient
0.00 RON

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

Price
42.18 RON
Copayment
42.18 RON
Patient
0.00 RON

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

Price
42.18 RON
Copayment
42.18 RON
Patient
0.00 RON

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

Price
42.18 RON
Copayment
42.18 RON
Patient
0.00 RON