MICOTEF "2% ORAL GEL" 1 TUBE OF 40 G"

Name
MICOTEF 2% oral gel
Miconazole


What is it and what is it used for?
MICOTEF oral gel is an anti-infective medicine and belongs to the category of dental drugs.
It is indicated for the treatment of oropharyngeal candidiasis (Candida infection of 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 section 6).
• In infants less than 6 months of age or in whom swallowing is not yet sufficiently developed
• In patients with liver disease
• In patients concomitantly receiving other drugs metabolised by 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 anticoagulant drugs, such as warfarin, the anticoagulant effect should be carefully monitored.
Particular care should be taken when administering MICOTEF oral gel to infants over 6 months of age and children to prevent the gel from blocking the throat. Therefore, the gel should not be applied to the throat. It is advisable to divide each dose into smaller portions and monitor the patient closely to avoid possible choking.


Possible side effects
Like all medicines, Micotef oral gel can cause side effects, although not everybody gets them.
If ingested, diarrhea may occur during long-term treatment. Nausea, headache, and skin rashes may occur rarely.
If any of the following side effects occur, 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 generalised exanthematous pustulosis).
Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effects, including any 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.