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Elea S.A.C.I.y A. - Argentina

LEFLUMAX
OVUMIX

Forms and presentation
Vaginal suppositories: Box of 6.

Composition
Each vaginal suppository contains: Metronidazole: 300 mg, Miconazole nitrate: 100 mg, Neomycin sulfate: 48.80 mg, Gotu Kola: 15 mg, Polymyxin sulfate: 4.40 mg.

Properties
In Ovumix, it is combined a healing, regenerative and protective tissues actions of Gotu Kola, with the anti-infective efficacy from the other active components on vulvovaginal membranes. Gotu Kola stimulates granulation process and promotes an adequate epithelization, Neomycin and Polymyxine cover a broad bacterial spectrum, on Gram+ and negative germs, Miconazole brings antifungal action and Metronidazole germicide actions against trichomones, giardias and amebas.

Indications
For local treatment of specific and non-specific vulvovaginitis, particularly when they are associated to vaginal damage; vulvitis, vaginitis, bacterial or irritative cervicovaginitis, candidiasis, thricomoniasis, leucorrheas of any kind of ethiology.

Contraindications
Hypersensitivity to any ingredients of this product or imidazolic derivatives. During the first trimester of pregnancy. Nursing mothers. Patients with hematology diseases. Active diseases of CNS.

Precautions
Ovumix should be administered with caution to patients with severe hepatic disease.
Do not use before coitus. Its use difficults fecundation.
The use of this product do not prevent the sexual diseases transmission.
Ingredients of vaginal suppositories may weaken latex of condoms and diaphragms.

Drug interactions
Avoid vaginal douches with alkaline substances.
Due to a low drug absorption by local application, systemic interactions cannot be excluded. It is not advisable the association with: alcohol (antubuse effect), warfarine, coumarine (anticoagulant potenciation) and disulfiram.

Side effects
Rarely could appear: burning, itching and vulvovaginal irritation. Keeping in mind that it’s not known how much the active ingredients could be absorbed across vaginal membranes, it cannot exclude systemic effects. The risk increases in patients with renal insufficiency.

Dosage and administration
Treatment should begin with 1-2 vaginal suppositories daily. When symptoms improve, continue with 1 suppository daily, at bedtime, until complete cure. Gently and deeply insert into the vagina. Apply at least during 5-10 days.

Overdosage
There is no overdose risk if the product is properly administered. In case of overdose seek medical assistance at the nearest hospital.

Storage conditions
Store at room temperature 15-30°C, avoid heat (over 30°C).

Origin: Argentina
Laboratories: Laboratorio Elea
Distributor: Droguerie Phenicia
Number & Year of Registration: 23730/2006