Micotef*os Gel 40g 2%

NAME
MICOTEF 2% ORAL GEL

PHARMACOTHERAPEUTIC CATEGORY
Stomatological.

ACTIVE PRINCIPLES
Miconazole (DCI) 20 mg.

EXCIPIENTS
Pregelatinised starch, saccharin sodium salt, polysorbate 20, purified water, orange tetraroma, cocoa flavor, alcohol, glycerin.

INDICATIONS
Treatment of candidiasis of the oropharynx (stomatitis and thrush).

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; in infants less than 6 months of age or in whom swallowing is not yet sufficiently developed; in patients with hepatic dysfunction; in patients receiving concomitantly drugs metabolised by the CYP3A4 enzyme system, ie: substances that prolong the QT interval (mizolastine, pimozide, quinidine, sertindole); ergot alkaloids; HMG-CoA reductase inhibitors such as simvastatin and lovastatin; oral triazolam and midazolam.

DOSAGE
Infants: a quarter of a measuring spoon 4 times a day after meals. Children and Adults: half a measuring spoon 3-4 times a day after meals. Spread the gel on the mucosa in order to allow the contact of the miconazole with the infected areas of the oral cavity, taking care to keep the gel in the mouth as long as possible. Continue the treatment for at least one week after the symptoms disappear.

STORAGE
Store at a temperature not exceeding 25 degrees C.

WARNINGS
In case of concomitant use of the medicinal product and oral anticoagulant drugs, such as warfarin, the anticoagulant effect should be carefully monitored and titrated. It is advisable to check the levels of miconazole and phenytoin, in case of concomitant intake of the two drugs. In patients being treated with certain oral hypoglycemic agents, such as sulfonylureas, an increased therapeutic effect may occur which can lead to hypoglycaemia if taken concomitantly with miconazole. Therefore, appropriate precautions must be taken. Particular care should be taken when administering the drug to infants over 6 months of age and children to prevent the gel from blocking the throat. For this, the gel should not be applied in the throat and it is advisable to divide each dose into smaller portions and monitor the patient to avoid possible choking.

INTERACTIONS
Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and CYP2C9 enzymatic system, therefore it can cause an increase and / or prolongation of their therapeutic and undesirable effects. For this reason, the use of oral miconazole is contraindicated in the co-administration of the following drugs, subject to metabolism through the CYP3A4 enzyme system: substances that prolong the QT interval (mizolastine, pimozide, quinidine, sertindole); ergot alkaloids; HMG-CoA reductase inhibitors such as simvastatin and elovastatin; oral triazolam and midazolam. Particular precaution should be used when co-administering oral miconazole and the following drugs due to the possible increase or prolongation of both therapeutic and undesirable effects. If necessary, their dosage should be reduced and, if necessary, their plasma levels monitored: drugs metabolized by the CYP2C9 enzyme system; oral anticoagulants such as warfarin; oral hypoglycemic agents such as sulfonylureas; phenytoin. Other drugs metabolised by the CYP3A4 enzyme system: HIV protease inhibitors such as saquinavir; some antineoplastic agents such as vinca alkaloids, busulfan and docetaxel; some calcium channel blockers such as dihydropyridines and verapamil; some immunosuppressive agents: cyclosporine, tacrolimus, sirolimus (rapamycin). Others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostazol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil and trimetrexate.

SIDE EFFECTS
If ingested, diarrheal episodes may occur during long-term treatment. Rare the onset of nausea, headache and skin rashes.

PREGNANCY AND BREASTFEEDING
Although there is no evidence that miconazole has teratogenic embryotoxic effects in animals, the potential risks of prescribing the drug during pregnancy need to be weighed against the potential therapeutic benefits. There are no data available on the excretion of miconazole in breast milk, therefore caution should be used when prescribing the product during lactation.