OTALGAN*EAR DROPS FL 6G

OTALGAN 10 mg/ml + 50 mg/ml ear drops, solution
Procaine hydrochloride + phenazone

What it is and what it is used for
OTALGAN contains the active ingredients procaine hydrochloride (a local anesthetic) and phenazone (an anti-inflammatory and pain reliever) and is used in adults and children for the treatment of earaches.

What you need to know before taking the medicine
Do not use OTALGAN:
- if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6);
- if you have a perforated eardrum.

Warnings and precautions
Talk to your doctor or pharmacist before using OTALGAN.

As a precaution, before administering the product, ensure that the eardrum membrane is intact.
Do not extend the administration of the medicine beyond 10 days; in any case, after a short period of treatment (1-2 days) without appreciable results, consult your doctor.

Children
In very young children, the product should be administered under the direct supervision of a doctor and only when strictly necessary.

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

Stop treatment and consult your doctor if sensitization or irritation occurs. Products for local application can cause these types of phenomena.

The use of phenazone has been associated with a high risk of agranulocytosis (severe reduction in the number of circulating white blood cells). Phenazone, like procaine, can cause allergic reactions in sensitized individuals and anaphylactic manifestations (severe, rapidly appearing allergic reactions) following the application of OTALGAN.
In case of eardrum perforation, the product, when in contact with the structure of the middle ear, can cause undesirable effects at that level (see Do not use OTALGAN).

Following the instructions in the package leaflet reduces the risk of side effects, which are generally temporary.

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.