OTOMIDONE*EAR DROPS 10ML

OTOMIDONE 25 mg/ml + 28.8 mg/ml ear drops
Phenazone + procaine hydrochloride

What it is and what it is used for
OTOMIDONE contains two active ingredients: phenazone, a painkiller, and procaine, a local anaesthetic.
This medicine is used to relieve pain in ear inflammations (otitis).

Consult your doctor if you do not feel better or if you feel worse after 1-2 days.

What you need to know before taking the medicine
Do not use OTOMIDONE
- if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6);
- if you are particularly sensitive to the active ingredients (idiosyncrasy to procaine or phenazone);
- if you suffer from myasthenia gravis (which causes muscle weakness and fatigue);
- if you have a damaged eardrum due to infection or trauma (eardrum perforation).

Warnings and precautions
Consult your doctor or pharmacist before using OTOMIDONE if you think you have ear injuries (eardrum membrane injuries). In the case of ear injuries, this medicine could cause effects that extend throughout the body (systemic effects).

Do not use for more than 10 days; after 1-2 days of treatment without noticeable results, consult your doctor. The use of topical (local) products can give rise to sensitisation phenomena (excessive reaction of the body to foreign substances with which it has come into contact) or irritation.
In this case, stop the treatment and consult your doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions may occur in people sensitive to the active ingredients contained in this medicine.
In case of eardrum perforation, this medicine can cause side effects that extend throughout the body (systemic effects), such as:
• decrease in certain blood cells (agranulocytosis);
• severe allergic reactions (anaphylactic manifestations).

Reporting of side effects
If you get 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.