Meclon 100 mg + 500 mg 10 ovules

INDICATIONS

Cervicitis, cervico-vaginitis, vaginitis and vulvo-vaginitis from Trichomonas vaginalis even if associated with Candida or with a bacterial component.

ACTIVE INGREDIENTS

A 2.4 g egg contains: Active ingredients: Metronidazole 500 mg; Clotrimazole 100 mg. For the full list of excipients, see section 6.1

EXCIPIENTS

Excipients: Hydrophilic mixture of mono, di, tri-glycerides of saturated fatty acids.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active ingredients or any of the excipients.

DOSAGE

The optimal therapeutic scheme is as follows: 1 MECLON ovule in the vagina, 1 time per day.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

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. MECLON ovali should be used in early childhood under the direct supervision of a doctor and only in cases of actual need. 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.

OVERDOSE

No symptoms of overdose have been described.

PREGNANCY AND BREASTFEEDING

During pregnancy, the product must be used only in case of actual need and under the direct supervision of a doctor.

EFFECTS ON DRIVING ABILITY

Meclon does not affect the ability to drive or use machines.