Clomezol
Overview
Clomezol
Ovules, 500 mg/200 mg/150 mg
COMPOSITION
Each ovule contains: metronidazole 500 mg, neomycin sulfate 200 mg, clotrimazole 150 mg.
Excipients: semi-synthetic solid glycerides.
WHAT IT IS USED FOR
A combination medicine for the local treatment of vaginal candidiasis (caused by Candida albicans), bacterial vaginosis (caused by anaerobic flora), Trichomonas vaginitis and mixed vaginal infections. It is also used to prevent vaginal superinfection before and after gynaecological procedures (abortion, cervical diathermocoagulation, endometrial biopsy, IUD insertion) and in patients receiving corticosteroids, immunosuppressants, cytostatics or antibiotics.
HOW IT WORKS
The components act together locally: metronidazole targets anaerobic bacteria and protozoa (including Trichomonas vaginalis), neomycin provides broad-spectrum antibacterial action against aerobic flora, and clotrimazole acts against fungi (including Candida albicans).
HOW TO USE
Administer deep into the vagina, one ovule twice daily (morning and evening) for 7 days. For recurrent infections or those resistant to other treatments — one ovule twice daily for 14 days. For prophylaxis before/after gynaecological procedures — one ovule in the evening. Do not use during menstruation. To prevent reinfection, simultaneous treatment of the sexual partner is recommended. For adults aged 18 years and over only.
WHEN IT SHOULD NOT BE USED
hypersensitivity to metronidazole, neomycin sulfate, clotrimazole, other imidazole derivatives or to any of the excipients;
first trimester of pregnancy;
breast-feeding;
children and adolescents under 18 years of age.
Important to know
Use with caution if you have a history of blood disorders or severe or progressive neurological conditions; regular blood tests and monitoring may be required. Stop treatment if you experience irregular vaginal bleeding, ulcerations or persistent burning.
Avoid alcohol during treatment and for at least 72 hours afterwards (risk of disulfiram-like reactions). The ovules may reduce the effectiveness of latex or rubber condoms and diaphragms and of vaginal spermicides — use alternative contraception during treatment and for a further 5 days. Sexual intercourse, tampons, vaginal douches and other vaginal products should be avoided during treatment. Do not drive or operate machinery if you experience dizziness, drowsiness, confusion, seizures or visual disturbances.
Read the package leaflet carefully before use.
Possible side effects
Local: burning, irritation, itching, redness or erosions in the vaginal or vulvar area.
Very rare or with unknown frequency: allergic reactions (including anaphylactic shock), blood disorders (leukopenia, neutropenia), headache, dizziness, drowsiness, seizures, psychiatric disturbances, vision or hearing disturbances, metallic taste, nausea, abdominal pain, increased liver enzymes, severe skin reactions, darkening of urine.
If side effects occur, stop using the product and consult a doctor or pharmacist.
STORAGE
Store below 25 °C in the original packaging. Do not freeze. Keep out of the reach of children. Shelf life: 24 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.