OTALGAN "1% + 5% EAR DROPS, SOLUTION" 6G BOTTLE

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


What is it and what is it for?
OTALGAN contains the active ingredients procaine hydrochloride (local anesthetic) and phenazone (anti-inflammatory and pain reliever) and is used in adults and children to treat earache.


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


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

Before administering the product, as a precaution, make sure that the eardrum is intact.
Do not continue taking the medicine for more than 10 days; in any case, after a short period of treatment (1-2 days) without appreciable results, consult your doctor.

Children
In early childhood, the product must be administered under the direct supervision of a doctor and only in cases of real need.


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

Discontinue treatment and consult your doctor if you experience any sensitization or irritation. Topical products may cause this type of reaction.

The use of phenazone has been associated with a high risk of agranulocytosis (a severe reduction in the number of white blood cells circulating in the blood). Phenazone, like procaine, can cause allergic reactions in sensitized individuals and anaphylactic reactions (severe, rapid-onset allergic reactions) following the application of OTALGAN.
In case of perforation of the eardrum, the product, in contact with the structure of the middle ear, may cause unwanted 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 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.