Leaflet SEBODERM MED 20mg / ml shampoo

Product code:
W69817001
Quantity:
1
Indicated for:
fungal infections
Route of administration:
cutaneous
Substance:
ketoconazole (azole antifungal)
ATC
D01AC08 — Dermatologicals | Antifungals for topical use | Imidazole and 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.

Ketoconazole is an antifungal medication used to treat infections caused by fungi and yeasts. It is available as a cream, shampoo, or tablets and is used for conditions such as seborrheic dermatitis, dandruff, tinea versicolor (a fungal skin infection), and other fungal infections of the skin or scalp.

In oral form, ketoconazole is used less frequently due to the risk of serious side effects, such as liver damage. It is reserved for severe fungal infections that do not respond to other treatments. Ketoconazole works by inhibiting the synthesis of ergosterol, an essential component of the fungal cell membrane, leading to the destruction of the fungi.

Side effects may include local irritation (for topical use), nausea, abdominal pain, or, in rare cases, liver toxicity (for oral use). It is important to use the medication as directed by a doctor, especially for oral treatment.

General data about SEBODERM MED 20mg / ml

Substance:
ketoconazole
Date of latest medicines list:
01-11-2023
Product code:
W69817001
Concentration:
20mg / ml
Pharmaceutical form:
shampoo
Quantity:
1
Product type:
Generic medicine
Prescription status:
OTC — Over the Counter = medicine that does not require a medical prescription.

Marketing authorisation

Manufacturer:
SLAVIA PHARM S.R.L. - ROMANIA
Holder:
SLAVIA PHARM S.R.L. - ROMANIA
Number:
14625/2022/01
Shelf life:
2 years-after packing for marketing;after the first opening of the bottle-3 months

Pharmaceutical forms available for ketoconazole

Concentrations available for ketoconazole

  • 1g/20g
  • 2%
  • 200mg
  • 20mg/g
  • 20mg/ml
  • 2mg/100mg
  • 400mg