Leaflet EXOTERFYN 78.22mg / ml medicated nail lacquer

Product code:
W69952001
Quantity:
1
Indicated for:
fungal infections
Route of administration:
cutaneous
Substance:
terbinafine (antifungal)
ATC
D01AE15 — Dermatologicals | Antifungals for topical use | Other antifungals for topical use

Precautions:

Dose adjustment in hepatic impairment

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Terbinafine is an antifungal medicine used for dermatophyte infections of the skin, nails or scalp, depending on the form. It may be used locally as a gel, cream or spray for skin fungal infections, while tablets are mainly used for nail infections or more extensive disease. It works by blocking ergosterol synthesis, which fungi need for their cell membranes.

Topical forms are applied to clean, dry skin for the recommended duration, even if symptoms improve quickly. Tablets are taken by mouth only when prescribed, because treatment may last weeks or months. In nail infections, improvement is slow because the healthy nail must grow out. Oral treatment should not be used without a correct diagnosis.

Side effects may include local irritation, itching or stinging with skin forms. Tablets may cause nausea, diarrhoea, abdominal pain, headache, rash, muscle pain, changes in taste or smell and, rarely, serious liver injury. The doctor may recommend liver tests before and during treatment.

Stop treatment and contact a doctor urgently if jaundice, dark urine, persistent nausea, severe tiredness, abdominal pain, widespread rash, fever or allergic reactions occur. Tell the doctor about liver disease, kidney disease, pregnancy, breastfeeding and all medicines used. Local hygiene, keeping skin dry and changing footwear can help prevent recurrence.

General data about EXOTERFYN 78.22mg / ml

Substance:
terbinafine
Date of latest medicines list:
01-03-2024
Product code:
W69952001
Concentration:
78.22mg / ml
Pharmaceutical form:
medicated nail lacquer
Quantity:
1
Product type:
Original
Prescription status:
OTC — Over the Counter = medicine that does not require a medical prescription.

Marketing authorisation

Manufacturer:
ALFASIGMA, S.P.A. - GERMANIA
Holder:
SANDOZ PHARMACEUTICALS S.R.L. - ROMANIA
Number:
13685/2021/01
Shelf life:
3 years-after packing for marketing;after the first opening-6 months

Concentrations available for terbinafine

  • 1%
  • 10.1mg/ml
  • 10mg/g
  • 125mg
  • 250mg
  • 78.22mg/ml