Package leaflet: Information for the patient

OTOMIDONE 25 mg/ml + 28.8 mg/ml ear drops

Phenazone + hydrochloride procaine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 1–2 days.

Contents of this leaflet:

What OTOMIDONE is and what it is used for
What you need to know before using OTOMIDONE
How to use OTOMIDONE
Possible side effects
How to store OTOMIDONE
Contents of the pack and other information

1. What OTOMIDONE is and what it is used for

OTOMIDONE contains two active substances: phenazone, an analgesic, and procaine, a local anaesthetic.
This medicinal product is used to relieve pain in ear inflammations (otitis).
Consult your doctor if you do not feel better or feel worse after 1-2 days.

2. What you need to know before using OTOMIDONE

Do not use OTOMIDONE

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you are particularly sensitive to the active substances (idiosyncrasy to procaine or phenazone);
if you suffer from severe myasthenia gravis (a condition causing muscle weakness and fatigue);
if you have a tympanic membrane damaged by infection or trauma (perforated eardrum).

Warnings and precautions
Consult your doctor or pharmacist before using OTOMIDONE if you suspect you have ear injuries (damage to the eardrum membrane). In case of ear injury, this medicine could cause effects affecting the entire body (systemic effects).
Do not use for more than 10 days; if after 1–2 days of treatment no noticeable improvement occurs, consult your doctor.
The use of topical (local) products may lead to sensitization (excessive immune response to foreign substances contacted) or irritation. In such cases, discontinue treatment and consult your doctor.

Other medicines and OTOMIDONE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only if your doctor considers it necessary and under medical supervision.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

OTOMIDONE container contains latex rubber
The container of this medicine contains latex rubber. It may cause severe allergic reactions.

3. How to use OTOMIDONE

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
The recommended dose is 3–4 drops in each ear.
If you are elderly, limit yourself to the lower doses.

Instructions for application

Clean the ear carefully with dry cotton;
Tilt your head to one side so that the ear (auricle) is in a horizontal position;
Instill 3–4 drops of the medicine;
Keep your head tilted for at least 5 minutes;
Plug the ear with a strip of bordered gauze or a cotton ball.
The medicine may also be used slightly warmed by warming the container in a water bath before use.

Duration of treatment
Repeat the application every hour until the pain subsides.
Thereafter, for 1–2 days, treat the ear every 2–3 hours.
Do not use the medicine for more than 10 days; if after 1–2 days of treatment there are no noticeable improvements, consult your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Allergic reactions may occur in individuals sensitive to the active substances contained in this medicine.
If the eardrum is perforated, this medicine may cause side effects affecting the whole body (systemic effects), such as:

reduction in certain blood cells (agranulocytosis);
severe allergic reactions (anaphylactic reactions).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OTOMIDONE

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OTOMIDONE contains

The active substances are phenazone, procaine hydrochloride. Each 1 ml of ear drops contains 25 mg of phenazone and 28.8 mg of procaine hydrochloride.
The other component is glycerol.

Description of the appearance of OTOMIDONE and contents of the pack
OTOMIDONE 25 mg/ml + 28.8 mg/ml ear drops is available in a 10 ml glass bottle.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)