Meclon 10 Vaginal Ovules 100+500 Mg

Meclon 10 Vaginal Ovules 100+500 mg 

PHARMACOTHERAPEUTIC CATEGORY:
Gynaecological anti-infectives and antiseptics/associations of imidazole derivatives.

ACTIVE INGREDIENTS:
Metronidazole; clotrimazole.

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

INDICATIONS:
Cervicitis, cervico-vaginitis, vaginitis and vulvo-vaginitis due to Trichomonas vaginalis even if associated with Candida or with bacterial component.

CONTRAINDICATIONS/SECONDARY EFFECTS:
Hypersensitivity to the active ingredients or any of the excipients.

POSOLOGY:
The optimal therapeutic schedule results in the following: 1 ovule in the vagina, 1 time per day.

STORAGE:
This medication does not require any special storage conditions.

WARNINGS:
Avoid contact with the eyes.
Concurrent use of oral Metronidazole is subject to the contraindications, side effects and warnings described for the above product.
Avoid treatment with the drug during the menstrual period.
The ova product should be used in early childhood only in cases of actual need.
Cases of severe hepatotoxicity/acute liver failure, including cases with fatal outcome, have been reported with metronidazole-containing medications for systemic use, with very sparse onset after initiation of treatment in patients with Cockayne syndrome.
Therefore, metronidazole should be used in this population after careful evaluation of the risk-benefit ratio and so 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 values at baseline are reached.
If liver function test values increase significantly during treatment, the drug should be discontinued.
Patients with Cockayne syndrome should be advised of the need to immediately report any symptoms of potential liver injury and discontinue treatment with metronidazole.

INTERACTIONS:
None.

UNDESIRABLE EFFECTS:
Given the poor absorption by local application of the active ingredients Metronidazole and Clotrimazole, adverse reactions seen with the topical formulations are limited to.
Immune system disorders o.
Not known: hypersensitivity reactions.
Skin and subcutaneous tissue disorders.
Very rare (frequency <1/10,000): local irritative phenomena such as itching, allergic contact dermatitis, rashes.
Any occurrence of undesirable effects results in discontinuation of treatment.

PREGNANCY AND LACTATION:
In pregnancy, the product should be used only when actually needed.