Otinum

Package Leaflet: Information for the User

Otinum

0.2 g/g, Ear Drops

Choline Salicylate

Read the 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 leaflet for the patient or as directed by the doctor.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Otinum and what is it used for
• 2. Important information 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 is Otinum and what is it used for

Otinum is a medicine indicated for short-term use in inflammatory conditions of the external auditory canal characterized by pain, itching, and redness.
The medicine is also recommended for softening earwax before rinsing the external auditory canal.
The active substance of Otinum ear drops is a derivative of salicylic acid - choline salicylate.
Choline salicylate used topically has analgesic and anti-inflammatory properties. This reduces pain and inflammation in the course of external auditory canal inflammation.
Glycerol contained in the medicine softens earwax in the ear, making it easier to remove.
After local administration to the ear, the medicine does not have a systemic effect.

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 with worsening hearing;
• if the patient has previously been diagnosed with eardrum damage (perforation or rupture);
• in individuals under 18 years of age.

Signs of eardrum perforation may include: sharp ear pain (gradually decreasing), ringing in the ears (which may indicate damage to deeper ear structures), hearing loss, dizziness, and/or discharge from the ear. The causes of eardrum damage (perforation) include infections, injuries (e.g., after improper ear cleaning with earbuds), and medical reasons (e.g., improper ear rinsing due to earwax).

Warnings and precautions

Before starting to use Otinum, the patient should discuss it with their doctor or pharmacist.
Any ear pain is a reason to consult a doctor.
Self-treatment of local symptoms of external auditory canal inflammation should not last longer than 3 days. The patient should contact their doctor immediately if there is no improvement after 3 days or if the symptoms worsen within 3 days of starting Otinum.
If additional symptoms appear, indicating a developing disease process (e.g., fever, malaise, weakness, dizziness, discharge from the ear), the patient should contact their doctor.
In the event of recurrence of the disease, the use of Otinum should be decided by the doctor.
Otinum may mask the symptoms of other ear diseases and make their proper diagnosis difficult or delayed.
The patient should inform their doctor about the use of Otinum.
Otinum should not be used contrary to the indications listed in the leaflet or with a different route of administration (e.g., orally, on open wounds, especially in the ear canal or in the eyes).

Otinum and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This also applies to over-the-counter medicines.
The medicine is used topically and does not have a systemic effect.
Concomitant use with non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen) may enhance the local effect.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

The medicine does not affect the ability to drive 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 the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Otinum is for topical use in the ear only.
Otinum is intended for use in adults.
If the patient feels that the effect of Otinum is too strong or too weak, they should consult their doctor.

Recommended dosage:

• For short-term treatment of local symptoms of acute external auditory canal inflammation: usually 3 to 4 drops into the external auditory canal every 6 to 8 hours, for a period not exceeding 3 days.
• For softening hardened earwax before its removal from the ear:

usually 3 to 4 drops into the external auditory canal every 12 hours, for a period not exceeding 3 days.
Elderly patients:
No dose adjustment is necessary.
Patients with liver or kidney function disorders:
No dose 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 treated ear is facing upwards.
• 3. Gently pull the earlobe (the lower part of the auricle) away from the neck.
• 4. With the bottle upside down, press it on both sides to administer 3-4 drops of the medicine into the treated ear.
• 5. For a few minutes, keep your head tilted so that the drops can flow into the auditory canal.
• 6. Wipe off any excess liquid with a clean cloth.
• 7. Close the Otinum bottle.

Additional tips for administering Otinum:

• 1. Having someone assist you with dropping the medicine into your ear or using a mirror can make it easier to administer the medicine.
• 2. Be careful not to get water into the ear after administering the medicine.
• 3. Do not share Otinum with other people.

Using a higher dose of Otinum than recommended

It is not possible to overdose on the medicine by administering it into the ear.
Symptoms of overdose that may occur after accidental oral ingestion of the medicine include: disorientation, dizziness, excessive sweating, vomiting, ringing in the ears, and overly intense breathing (hyperventilation). In the event of taking very large doses of the medicine orally, there may be central nervous system disorders, including breathing and circulation disorders.
In the event of oral ingestion of the medicine, the patient should immediately consult their doctor.

Missing a dose of Otinum

If a dose of the medicine is missed at the scheduled time, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the following side effects is unknown (cannot be estimated from the available data).
Local hypersensitivity reactions (redness and itching of the skin).
In patients with eardrum perforation during the use of the medicine, there may be hearing damage.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Otinum

Store below 25°C.
Store 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. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Otinum contains

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

What Otinum looks like and contents of the pack

The packaging of the medicine is a 10 ml polyethylene bottle with a dropper, closed with a screw cap with a tamper-evident ring, in a cardboard box. The packaging contains 10 g of the medicine.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-105 Rzeszów

Date of last revision of the leaflet: 30.04.2025