OTOMIDONE 10 ML Ear drops, solution

Зміст інструкції

1. OTOMIDONE 25 mg/ml + 28.8 mg/ml ear drops
   1. What is OTOMIDONE and what is it used for
   2. What you need to know before using OTOMIDONE
   3. How to use OTOMIDONE
   4. Possible side effects
   5. How to store OTOMIDONE
   6. Contents of the pack and other information

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

Fenazone + procaine hydrochloride

Read this leaflet carefully before using this medicine as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 1-2 days.

Contents of this leaflet:

• 1. What OTOMIDONE is and what it is used for
• 2. What you need to know before using OTOMIDONE
• 3. How to use OTOMIDONE
• 4. Possible side effects
• 5. How to store OTOMIDONE
• 6. Contents of the pack and other information

1. What is OTOMIDONE and what is it used for

OTOMIDONE contains two active ingredients: phenazone, a pain reliever, and procaine, a local anesthetic.
This medicine is used to relieve pain in ear inflammations (otitis).
See your doctor if you do not feel better or if you 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 ingredients or to 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 your eardrum is damaged by an infection or trauma (eardrum perforation).

Warnings and precautions
Talk to your doctor or pharmacist before using OTOMIDONE if you think you have ear injuries
(damage to the eardrum). In case of ear injuries, this medicine may cause
effects that spread throughout the body (systemic).
Do not use for more than 10 days; after 1-2 days of treatment without appreciable results, consult your
doctor. The use of topical (local) products can give rise to sensitization
(excessive reaction of the body to foreign substances with which it has come into contact) or irritation. In
such cases stop the treatmentand consult your doctor.

Other medicines and OTOMIDONE
Tell 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 are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only if your doctor has deemed it necessary and under his
supervision.

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

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

3. How to use OTOMIDONE

Use this medicine following 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 using the lowest doses.
Instructions for application

• clean the ear thoroughly with dry cotton;
• tilt your head to the side so that the ear (pinna) is in a horizontal position;
• instill 3 - 4 drops of 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 can also be used lukewarm by warming the container in a water bath before use.

Duration of treatment
Repeat the application every hour until the pain disappears.
Subsequently, for 1 – 2 days, treat the ear every 2 – 3 hours.
Do not use the medicine for more than 10 days; after 1 – 2 days of treatment without appreciable results
consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions are possible in people sensitive to the active substances contained in this
medicine.
In case of a perforated eardrum, this medicine may cause side effects that extend
throughout the body (systemic), such as:

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Expiry”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OTOMIDONE contains

• The active ingredients are phenazone, procaine hydrochloride. 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 authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)