CLOTRIMAZOL

Clotrimazole

Ovules, 100 mg and 500 mg

Each ovule contains clotrimazole 100 mg or 500 mg.

Excipients: semi-synthetic solid glycerides.

An antifungal medicine for the local treatment of vaginal candidiasis (vaginal infections caused by Candida).

Clotrimazole 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 minimal (3–10 % of the dose).

Administer deep into the vagina while lying down. Clotrimazole 100 mg: 1 ovule per day, in the evening, for 6 days, or 2 ovules per day (morning and evening) for 3 days. Clotrimazole 500 mg: 1 ovule as a single dose in the evening. If necessary, the treatment may be repeated. Do not use during menstruation. Sexual intercourse, tampons, vaginal douches, spermicides and other vaginal products should be avoided during treatment. For adults and adolescents aged 16 years and over.

Hypersensitivity to clotrimazole or to any of the excipients. Not to be used in children under 16 years of age.

Important to know

Consult your doctor before use if this is the first time you have had symptoms of candidiasis, if you have had more than 2 candidal infections in the past 6 months, if you are pregnant or suspect pregnancy, or if you have a history of sexually transmitted diseases.

Do not use the product if you have irregular vaginal bleeding, ulcerations or blisters, lower abdominal pain, fever (≥38 °C) or chills, nausea, vomiting, diarrhoea or foul-smelling vaginal discharge — in these cases consult a doctor. The ovules may reduce the effectiveness of latex condoms and diaphragms — use alternative contraception during treatment and for at least 5 days afterwards. During pregnancy and breast-feeding, use only under medical supervision. If symptoms do not improve after one week of treatment or the infection recurs more than twice in 6 months, consult a doctor.

Read the package leaflet carefully before use.

Possible side effects

Local: vulvovaginal discomfort, burning, itching, redness, peeling, vaginal pain or bleeding, discharge.

Rare or with unknown frequency: hypersensitivity reactions (including anaphylactic reactions, angioedema, urticaria, dyspnoea, hypotension, syncope), skin rashes, abdominal pain, nausea.

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

Store below 25 °C in the original packaging. Keep out of the reach of children. Shelf life: 36 months.

Clotrimazole 100 mg: 1 PVC/PE blister with 6 ovules, together with the package leaflet, in a carton box. Clotrimazole 500 mg: 1 PVC/PE blister with 1 ovule, 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.