CERULISINA DOLORE*EAR DROPS FL6G

CERULISINA DOLORE 1% + 5% ear drops, solution
Procaine hydrochloride and phenazone

What it is and what it is used for
CERULISINA DOLORE is a combination of two active ingredients: procaine hydrochloride and phenazone. Procaine hydrochloride belongs to a group of medicines called local anesthetics, which relieve pain in the area where they are applied, while phenazone, which belongs to a group of medicines called anti-inflammatory and analgesic drugs, reduces inflammation and pain.

This medicine is indicated for the treatment of ear pain (otalgia).

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 CERULISINA DOLORE
- if you are allergic or have previously experienced an allergy to procaine hydrochloride, phenazone, other chemically similar substances or any of the other ingredients of this medicine (listed in paragraph 6);
- if you have or have had a perforated eardrum, as side effects may occur in the middle ear.

Warnings and precautions
Consult your doctor or pharmacist before using CERULISINA DOLORE.

In particular, before using this medicine, consult your doctor, who will, as a precautionary measure, check for any damage to the eardrum.

CERULISINA DOLORE may cause allergic reactions and irritation at the application site. In such a case, discontinue treatment and inform your doctor who will establish appropriate therapy.
Do not use this medicine for prolonged treatments. If you do not notice appreciable results after a short period of treatment (1-2 days), consult your doctor.

Children
In very young children, CERULISINA DOLORE is recommended only if absolutely necessary and not for prolonged treatments.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following may occur with unknown frequency (frequency cannot be estimated from the available data):
- middle ear side effects, if a perforated eardrum is present;
- reduction in the number of a type of white blood cells (agranulocytosis) and allergic reactions, even severe (anaphylactic reactions), following the passage of this medicine into the blood (systemic absorption).

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.