MICOTEF*ORAL GEL 40G 2%

MICOTEF 2% oral gel
Miconazole

What it is and what it is used for
MICOTEF oral gel is an anti-infective medicine and belongs to the category of stomatological drugs.
It is indicated for the treatment of oropharyngeal candidiasis (Candida infection in the mouth and pharynx): stomatitis and thrush.

What you need to know before taking the medicine
Do not take MICOTEF oral gel:
• If you are allergic to the active substance or other similar antifungal medicines or to any of the other ingredients of this medicine (listed in paragraph 6).
• In infants under 6 months of age or whose swallowing is not yet sufficiently developed.
• In patients with liver disease.
• In patients concomitantly receiving other drugs metabolized through the same pathway, in particular:
- Mizolastine, pimozide, quinidine, sertindole
- Ergot alkaloids
- HMG-CoA reductase inhibitors such as simvastatin and lovastatin
- Triazolam and midazolam.

Warnings and precautions
In case of concomitant use of MICOTEF oral gel and oral anticoagulants, such as warfarin, the anticoagulant effect should be carefully monitored.
Particular attention should be paid when administering MICOTEF oral gel to infants over 6 months of age and children to prevent the gel from obstructing the throat. For this reason, 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.

Possible side effects
Like all medicines, Micotef oral gel can cause side effects, although not everybody gets them.
If ingested, diarrheal episodes may occur during long-term treatment. Rare occurrence of nausea, headache, and skin rashes.
If you experience any of the following side effects, do not use Micotef and contact your doctor immediately:
• Swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing (angioedema, anaphylactic reaction).
Tell your doctor or pharmacist if you notice any of the following side effects:
not known:
• Skin rash with pus-filled blisters (acute generalized exanthematous pustulosis).
Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.