Otinum

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Otinum (Otinum 200 mg/g)
0.2 g/g, ear drops, solution
Choline salicylate
Otinum and Otinum 200 mg/g are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by the physician.
• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if you feel worse, you should contact your doctor.

Leaflet contents:

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

1. What Otinum is and what it is used for

Otinum is a medicine indicated for short-term use in inflammatory conditions of the external
auditory canal associated with pain, itching, and redness.
It is also recommended for softening earwax prior to irrigation of the external auditory canal.
The active substance in Otinum ear drops, solution, is a derivative of salicylic acid:

• choline salicylate. When applied topically, choline salicylate has analgesic and anti-inflammatory properties. Thus, it reduces pain and inflammation associated with external otitis. Glycerol contained in the medicine softens earwax, facilitating its removal. When administered locally into the ear, the medicine does not produce systemic effects.

2. Important information before using Otinum

When not to use Otinum

• if the patient is allergic to choline salicylate, other salicylates (e.g. acetylsalicylic acid / aspirin) or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has bleeding or discharge from the ear;
• if the patient experiences severe ear pain accompanied by hearing loss;
• if the patient has previously been diagnosed with tympanic membrane damage (perforation or disruption of continuity);
• in individuals under 18 years of age.

Signs suggestive of tympanic membrane perforation include: acute ear pain (gradually decreasing), tinnitus (which may indicate damage to deeper ear structures), hearing loss, dizziness, and/or ear discharge. Causes of tympanic membrane damage (perforation) include infections, injuries (e.g. due to improper ear cleaning with cotton swabs), and medical procedures (e.g. improper ear irrigation due to cerumen impaction).

Warnings and precautions

Before starting to use Otinum, consult a doctor or pharmacist.
Any ear pain should prompt consultation with a doctor.
Self-treatment of local symptoms of external auditory canal inflammation should not last longer than 3 days. Contact a doctor immediately if there is no improvement after 3 days or if symptoms worsen within the first 3 days of using Otinum.
If additional symptoms appear, indicating a developing illness (e.g. fever, malaise, weakness, dizziness, ear discharge), contact a doctor.
In case of recurrent illness, the decision on using Otinum should be made by a doctor.
Otinum may mask symptoms of other ear diseases and may hinder or delay their proper diagnosis.
Inform the doctor about using this medicine.
Do not use Otinum contrary to the indications listed in the leaflet or by another route of administration (e.g. orally, on open wounds, especially within the auricle, or into the eyes).

Otinum and other medicines

Inform the doctor or pharmacist about all medicines currently or recently used, as well as any medicines the patient plans to use. This also includes medicines available without a prescription.
The medicine is applied locally and does not exhibit systemic effects.
Concomitant use with non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen) may enhance local effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Otinum does not affect the ability to drive motor vehicles or operate machinery.

Otinum contains chlorobutanol hemihydrate
(a preservative).

3. How to use Otinum

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Otinum is for topical use in the ear only.
Otinum is intended for use in adults.
If you feel that the effect of Otinum is too strong or too weak, consult your doctor.

Recommended dosage:

• For short-term treatment of local symptoms of acute external otitis: usually 3 to 4 drops into the external auditory canal every 6 to 8 hours, for no longer than 3 days.
• To soften hardened cerumen prior to its removal from the ear: usually 3 to 4 drops into the external auditory canal every 12 hours, for no longer than 3 days.

Elderly patients:
No dosage adjustment is necessary.
Patients with hepatic and/or renal impairment:
No dosage adjustment is necessary.

Instructions for administering Otinum:

1. Wash your hands and then unscrew the cap from the bottle.
2. Tilt your head or lie on your side so that the affected ear faces upward.
3. Gently pull the earlobe (lower part of the auricle) away from the neck.
4. Invert the opened Otinum bottle upside down and, by gently squeezing it, administer 3–4 drops of the medicine into the affected ear.
5. Keep your head tilted for several minutes to allow the drops to flow into the ear canal.
6. Wipe away excess liquid with a clean tissue.
7. Screw the cap back onto the Otinum bottle.

Additional tips for administering Otinum:

1. Having another person assist with instilling the ear drops or using a mirror may facilitate administration.
2. Take care to avoid getting water into the ear that has already received the medicine.
3. Do not share Otinum with other people.

Use of a higher than recommended dose of Otinum
Overdose is not possible when the medicine is administered into the ear.
Symptoms of overdose that may occur after accidental oral ingestion include:
disorientation, dizziness, excessive sweating, vomiting, tinnitus, and abnormally rapid breathing (hyperventilation). Ingestion of very large oral doses may lead to central nervous system disturbances, resulting in respiratory and circulatory disorders.
In case of accidental oral ingestion, seek immediate medical advice.

Missed dose of Otinum
If a dose is missed at the scheduled time, administer it as soon as possible.
However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this product may cause side effects, although not everybody experiences them.
The frequency of occurrence of the side effects listed below is unknown (cannot be estimated from the available data).
Local hypersensitivity reactions (redness and itching of the skin).
In individuals with a perforated eardrum, use of the medicine may result in hearing damage.

Reporting of side effects
If any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Otinum

Do not store above 25°C.
Keep in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What Otinum contains

• The active substance is choline salicylate. 1 g of drops contains 0.2 g of choline salicylate.
• Other ingredients are: glycerol, ethanol 96%, chlorobutanol hemihydrate, purified water.

What Otinum looks like and contents of the pack
A clear, yellowish liquid with a characteristic odour.
The medicine is packaged in an LDPE bottle with a dropper and a screw cap, placed in a cardboard box.
The pack contains 10 g of medicine.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Lithuania, the country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Dublin
Ireland

Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-959 Rzeszów
Poland

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Marketing Authorisation number in Lithuania, the country of export: LT/1/94/1929/001
Parallel Import Licence number: 282/20