Micotef 2% - oral gel for the treatment of oropharynx candidiasis 40 g

Product Description

Oral Gel

Composition:

1 gram of oral gel contains: Active ingredient: miconazole (D.C.I.) 20 mg. For the full list of excipients, see section 6.1.

Excipients

Pregelatinized starch, saccharin sodium salt, polysorbate 20, purified water, orange tetraflavour, cocoa flavouring, alcohol, glycerin.

Therapeutic indications

Treatment of oropharyngeal candidiasis (stomatitis and thrush).

Contraindications

Micotef oral gel is contraindicated in the following cases: – Hypersensitivity to the active ingredient 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 liver dysfunction – In patients concomitantly receiving drugs metabolized by the CYP3A4 enzyme system, i.e.: a. Substances that prolong the QT interval (mizolastine, pimozide, quinidine, sertindole) b. Ergot alkaloids c. HMG-CoA reductase inhibitors such as simvastatin and lovastatin d. Oral triazolam and midazolam.

Dosage

Infant: ¼ measuring spoon 4 times a day after meals. Children and Adults: ½ measuring spoon 3–4 times a day after meals. Spread the gel on the mucosa so as to allow the miconazole to come into contact with the infected areas of the oral cavity, taking care to retain the gel in the mouth for as long as possible. Continue treatment for at least one week after the symptoms have disappeared.

Warnings and precautions

If Micotef Oral Gel is used concomitantly with oral anticoagulants, such as warfarin, the anticoagulant effect should be carefully monitored and titrated. It is advisable to monitor miconazole and phenytoin levels if the two drugs are taken concomitantly. Patients being treated with certain oral hypoglycemic agents, such as sulfonylureas, may experience an increased therapeutic effect, which can lead to hypoglycemia, if they take miconazole concomitantly. Therefore, appropriate precautions must be taken (see section 4.5 Interactions with other medicinal products and other forms of interaction). Particular care must be taken when administering Micotef gel to infants over 6 months of age and children to prevent the gel from obstructing the throat. Therefore, the gel should not be applied to the throat and it is advisable to divide each dose into smaller portions and monitor the patient to avoid possible choking. Keep out of reach of children.

Interactions

Other forms of interaction Miconazole can inhibit the metabolism of drugs metabolized by the CYP3A4 and CYP2C9 enzyme systems, thus causing an increase and/or prolongation of their therapeutic and adverse effects. For this reason, the use of oral miconazole is contraindicated in the co-administration of the following drugs, subject to metabolism via the CYP3A4 enzyme system (see section 4.3 Contraindications): • 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 Particular caution should be used in the co-administration of oral miconazole and the drugs listed below due to the possible increase or prolongation of both therapeutic and adverse effects. If necessary, their dosage should be reduced and, if necessary, their plasma levels monitored: 1. Drugs metabolised by the CYP2C9 enzyme system (see section 4.4 Special warnings and special precautions for use) • Oral anticoagulants such as warfarin • Oral hypoglycaemics such as sulfonylureas • Phenytoin 2. 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: ciclosporin, tacrolimus, sirolimus (rapamycin) • Others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostazol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil, and trimetrexate.

Undesirable effects

If ingested, diarrhea may occur during long-term treatment. Nausea, headache, and skin rashes may occur rarely.

Pregnancy and breastfeeding

Although there is no evidence that miconazole has embryotoxic or teratogenic effects in animals, the potential risks of prescribing Micotef oral gel during pregnancy must be weighed against the potential therapeutic benefits. There are no data available on the excretion of miconazole in breast milk, therefore caution should be exercised when prescribing Micotef oral gel during breastfeeding.