Meclon 20% + 4% 30 g vaginal cream with 6 applicators

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Vaginal cream: Cervico-vaginitis and vulvo-vaginitis caused by Trichomonas vaginalis even if associated with Candida albicans, Gardnerella vaginalis and other sensitive bacterial flora. MECLON vaginal cream can also be used on the partner for prophylactic purposes. Vaginal solution: Adjuvant in the therapy of cervico-vaginitis, vulvo-vaginitis caused by Trichomonas vaginalis even if associated with Candida albicans, Gardnerella vaginalis and other sensitive bacterial flora. MECLON vaginal solution can also be used after other topical or oral therapy, in order to reduce the risk of relapses.

CONTRAINDICATIONS

Hypersensitivity to the active ingredients or any of the excipients.

WARNINGS AND PRECAUTIONS FOR USE

Inform the patient to avoid contact with eyes. The simultaneous use of oral Metronidazole is subject to the contraindications, side effects and warnings described for the aforementioned product. Avoid treatment with Meclon during the menstrual period. Cases of severe hepatotoxicity/acute liver failure, including cases with fatal outcome, with very rapid onset after starting treatment in patients suffering from Cockayne syndrome, have been reported with metronidazole-containing medicinal products for systemic use. Therefore, in this population metronidazole should be used after a careful evaluation of the risk-benefit ratio and only in the absence of alternative treatments. Liver function tests should be performed just before the start of therapy, during and after the end of treatment, until liver function parameters have returned to normal or baseline values ​​have been reached. If liver function test values ​​increase significantly during treatment, the drug should be discontinued. Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their doctor and to discontinue treatment with metronidazole.

INTERACTIONS

None.

SIDE EFFECTS

Given the poor absorption by local application of the active ingredients Metronidazole and Clotrimazole, the adverse reactions found with topical formulations are limited to: Immune system disorders. Not known (frequency cannot be estimated from the available data): hypersensitivity reactions. Pathologies of the skin and subcutaneous tissue. Very rare (frequency <1/10,000): local irritative phenomena such as itching, allergic contact dermatitis, skin rashes. The possible occurrence of side effects leads to the interruption of treatment. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.