NEWMEZOLE
Metronidazole 300 mg
Miconazole nitrate 100 mg
Neomycin sulfate 48,80 mg
Gotu Kola 15 mg
Polymyxin sulfate 4,40 mg
Vaginal suppositories
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. Inactive ingredients: mix for suppositories (Witepsol H15) as need to 2 g.
Therapeutical action:
In Newmezole, it is combined a healing, regenerative and protective tissues actions of Gotu Kola, with the anti-infective ecacy from the other active components on vulvovaginal membranes. Gotu Kola stimulates granulation process and promotes an adequate epithelization, neomycin and polymixin cover a broad bacterial spectrum, on Gram positive and negative germs, miconazole brings antifungal action and metronidazole germicide actions against trichomones, giardias and amebas.
Indications:
For local treatment of speci‑c and non-speci‑c vulvovaginitis, particularly when they are associated to vaginal damage; vulvitis, vaginitis, bacterial or irritative cervicovaginitis, candidiasis, thricomoniasis, leucorrheas of any kind of etiology.
Posology 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 during 5 to 10 days, at least.
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 eect. The risk increases in patients with renal insuciency.
Contraindications: – Hypersensitivity to any ingredients of this product or imidazolic derivatives. – During the ‑rst trimester of pregnancy. – Nursing mothers. – Patients with hematology diseases. – Active diseases of Central nervous System.
Warning:
Newmezole should be administered with caution to patients with severe hepatic disease. Do not use before coitus.Its use dicults fecundation. The use of this product does 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, warfarine, coumarine and disul‑ram.
Overdose: There is no overdose risk if the product is properly administered. In case of overdose, see medical assistance at the nearest hospital.
Storage and stability: Store at room temperature 15 to 30 °C (59 to 86 °F), avoid heat (over 30 °C or 86 °F).
How supplied:
Package with 6 vaginal suppositories.
Keep this and all drugs out of the reach of children. Sale under prescription. Laboratorio Elea Phoenix S.A. Legal Address: Av. del Libertador N° 6550, ‑oor 3, (Zip Code C1428ARV), CABA, República Argentin
