Econazol

Econazole

Ovules, 50 mg and 150 mg

Each ovule contains econazole nitrate 50 mg or 150 mg.

Excipients: semi-synthetic solid glycerides.

An antifungal medicine for the local treatment of vaginitis caused by Candida albicans or other susceptible fungi.

Econazole nitrate is a broad-spectrum antifungal of the imidazole class. It acts locally by disrupting the cell membrane of fungi (particularly Candida), which stops their growth and leads to their death. Systemic absorption through the vaginal mucosa is limited.

Administer deep into the vagina while lying down. Econazole 50 mg: 1 ovule in the morning and 1 ovule in the evening at bedtime, for 7 days. Econazole 150 mg: 1 ovule in the evening at bedtime for 3 consecutive days; if the response is insufficient, the course may be extended for another 3 days and may be repeated after 10 days. For adults and adolescents aged 16 years and over.

Hypersensitivity to econazole nitrate, other imidazole derivatives or to any of the excipients. Not to be used in children under 16 years of age.

Important to know

For vaginal use only — do not take by mouth. During pregnancy, use only if absolutely necessary and after consulting your doctor; during breast-feeding, use with caution. Stop treatment if severe irritation or hypersensitivity reactions occur.

Econazole nitrate may damage the integrity of latex condoms and diaphragms, increasing the risk of rupture — use alternative contraception during treatment. It may also reduce the effectiveness of vaginal spermicides. Do not use concurrently with other vaginal treatments. In patients on oral anticoagulants (warfarin, acenocoumarol), more frequent monitoring is required as econazole may potentiate the anticoagulant effect.

Read the package leaflet carefully before use.

Possible side effects

Common: itching, burning sensation of the skin. Uncommon: skin rashes, vulvovaginal burning sensation.

Rare or with unknown frequency: erythema, hypersensitivity reactions, angioedema, urticaria, contact dermatitis, skin exfoliation, pain or irritation at the application site.

If side effects occur, stop using the product and consult a doctor or pharmacist.

Store below 25 °C in the original packaging. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.

Econazole 50 mg: 5 ovules per PVC/PE blister; 3 blisters together with the package leaflet in a carton box. Econazole 150 mg: 3 ovules per PVC/PE blister; 1 blister together with the package leaflet in a carton box.

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.