Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Otinum
0.2 g/g (200 mg/g), ear drops, solution
Choline salicylate
Please read the entire 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, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of contents of the leaflet:

What Otinum is and what it is used for
Important information before using Otinum
How to use Otinum
Possible side effects
How to store Otinum
Contents of the pack and other information

1. What Otinum is and what it is used for

Otinum is a medicine indicated for immediate use in inflammatory conditions of the external auditory canal associated with pain, itching and redness.
The medicine is also recommended for softening earwax prior to irrigation of the external auditory canal.
The active substance in Otinum ear drops is choline salicylate, a derivative of salicylic acid.
When applied locally, choline salicylate has analgesic and anti-inflammatory properties. Therefore, it reduces pain and inflammation associated with external otitis.
The glycerol contained in the medicine softens earwax, facilitating its removal.
When administered locally into the ear, the medicine does not exert systemic effects.

2. Important information before using Otinum

When not to use Otinum?

if the patient is allergic (hypersensitive) to the active substance (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 a perforated eardrum (rupture or discontinuity of the membrane);
in individuals under 18 years of age.

Signs suggestive of eardrum 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 eardrum damage (perforation) include: infections, trauma (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

Any ear pain should prompt consultation with a physician.
This medicine, used for the treatment of inflammation of the external auditory canal without prior medical consultation, should only be used temporarily and not for longer than 3 days. If there is no improvement or if symptoms worsen despite using Otinum as directed for 3 days, medical advice should be sought.
If additional symptoms appear, indicating a developing illness (e.g. fever, malaise, weakness, dizziness, ear discharge), the patient should contact a physician.
In case of recurrent episodes, the decision to use Otinum should be made by a physician.
Otinum may mask symptoms of other ear diseases and may complicate or delay their correct diagnosis.
The physician should be informed about the use of this medicine.
Otinum contains a preservative – chlorobutanol hemihydrate.
Otinum must not be used in a manner inconsistent with the indications listed in this leaflet or by alternative routes of administration (e.g. orally, on open wounds, particularly within the auricle, or into the eyes).

Otinum and other medicines

Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those available without a prescription.
Otinum is applied topically 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Otinum has no influence on the ability to drive motor vehicles or operate machinery.

3. How to use Otinum?

This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your 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. Do not use Otinum for longer than 3 days without medical advice.
To soften hardened earwax prior to its removal: usually 3 to 4 drops into the external auditory canal every 12 hours for 4 days.
Elderly patients: No dosage adjustment is necessary.

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

Instructions for administering Otinum:

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

Additional tips for administering Otinum:

Assistance from another person when instilling the drops or the use of a mirror may make administration easier.
Take care to avoid getting water into the ear that has already received the medicine.
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). After accidental ingestion of very large doses, disturbances of the central nervous system may occur, leading, among others, to respiratory and circulatory disorders.
In case of accidental oral ingestion, seek immediate medical advice.

Missed dose of Otinum
If you miss a dose 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the adverse reactions listed below is unknown (cannot be determined from available data).
Local hypersensitivity reactions (skin redness and itching).
In individuals with perforation of the eardrum, hearing damage may occur during treatment with this medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions 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 adverse reactions enables better assessment of the safety of the medicine.

5. How to store Otinum

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Store in the original packaging.
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 the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Otinum contains

The active substance is choline salicylate. 1 g of drops contains 0.2 g (200 mg) of choline salicylate.
The other ingredients are: glycerol, ethanol 96%, chlorobutanol hemihydrate, purified water.

What Otinum looks like and contents of the pack
The medicine is packed in a 10 ml PE bottle with a dropper and a cap with a tamper-evident ring,
together with a cardboard box. The pack contains 10 g of medicine.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Lithuania, the exporting country:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15, Dublin, Ireland
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
Poland
Parallel importer:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Lithuania, the exporting country: LT/1/94/1929/001
Parallel import authorization number: 153/15