Ketoconazole
Overview
Ketoconazole
Ovules, 400 mg
COMPOSITION
Each ovule contains: ketoconazole 400 mg.
Excipient with known effect: butylated hydroxyanisole (E320) 0.5 mg.
Other excipients: semi-synthetic solid glycerides.
WHAT IT IS USED FOR
An antifungal medicine for the local treatment of acute and chronic recurrent vaginal candidiasis. It is also used to prevent vaginal candidiasis in cases of reduced body resistance and during treatment with antibiotics or other medicines that disturb the vaginal flora.
HOW IT WORKS
Ketoconazole is a synthetic broad-spectrum antifungal of the imidazole group for local use. It inhibits the synthesis of ergosterol — a key component of fungal cell membranes — which disrupts the membrane and leads to fungal cell death. It is active against yeast-like fungi of the Candida genus and other pathogens.
HOW TO USE
Administered intravaginally (insert deep into the vagina) in the evening at bedtime, in a lying position.
Recommended regimen:
one ovule per day for 3–5 days, depending on the course of the disease;
for chronic recurrent candidiasis — one ovule per day for 10 days.
Treatment should be started on the first day after the end of the menstrual cycle. In chronic recurrent forms, local treatment may be combined with an oral antifungal medicine, as prescribed by the doctor.
WHEN IT SHOULD NOT BE USED
hypersensitivity to ketoconazole, to other imidazole derivatives or to any of the excipients;
first trimester of pregnancy.
Important to know
Do not use during menstruation — the ovule may be washed out with menstrual flow. Sexual intercourse is not recommended during treatment. The medicine may damage latex products (condoms, diaphragms) and reduce their reliability. To reduce the risk of recurrence, simultaneous treatment of the sexual partner is recommended. During the second and third trimesters of pregnancy and during breast-feeding, use only as directed by a doctor, when the expected benefit to the mother outweighs the potential risk. Avoid contact with the eyes. The medicine has no or negligible influence on the ability to drive and use machines.
Possible side effects
Local (frequency not known): redness and irritation of the vaginal mucosa, burning sensation, itching. Rare: allergic reactions — urticaria, anaphylactic reactions. Rarely, local allergic reactions may occur in the sexual partner (redness of the penis). If side effects or irritation occur, stop using the product and consult a doctor.
STORAGE
Store below 25 °C. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.
QUESTIONS AND CONTACTS
For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.
Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.