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 all of this leaflet carefully before using this medicine, because it contains important information for you.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor.
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, tell your doctor, pharmacist or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

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 short-term use in inflammatory conditions of the external auditory canal associated with pain, itching and redness.
The product 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 locally, choline salicylate has analgesic and anti-inflammatory properties. Thus, it reduces pain and inflammation associated with external otitis. The glycerol contained in the product softens earwax, facilitating its removal. After local administration into the ear, the medicine does not exert systemic effects.

2. Important information before using Otinum

When must Otinum not be used?

if the patient is allergic (hypersensitive) to the active substance (choline salicylate), to other salicylates (e.g. acetylsalicylic acid/aspirin), or to any of the other components 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 earwax).

Warnings and precautions

Any ear pain should prompt consultation with a doctor.
This medicine, used for the treatment of inflammation of the external auditory canal without prior medical consultation, may be used only temporarily, for no longer than 3 days. If there is no improvement or if symptoms worsen despite using Otinum at the recommended doses for 3 days, medical advice must be sought.
If additional symptoms appear, indicating a developing disease (e.g. fever, malaise, weakness, dizziness, ear discharge), the patient should contact a doctor.
In case of recurrent illness, the decision to use Otinum should be made by a doctor.
Otinum may mask symptoms of other ear diseases and may complicate or delay their correct diagnosis.
The doctor should be informed about the use of this medicine.
Otinum contains a preservative – chlorobutanol hemihydrate.
Otinum must not be used contrary to the indications listed in the 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 the 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 intensify local effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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.

3. How to use Otinum

This medicine should always be used exactly as described in the 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 ear canal inflammation:

usually 3 to 4 drops into the external ear canal every 6 to 8 hours.
Without medical advice, Otinum should not be used for longer than 3 days.

To soften hardened earwax prior to its removal:

usually 3 to 4 drops into the external ear canal every 12 hours for four days.

Elderly patients:
No dosage adjustment is required.
Patients with impaired liver and/or kidney function:
No dosage adjustment is required.

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 (lower part of the auricle) away from the neck.
Invert the opened Otinum bottle upside down and, by gently squeezing it on both sides, 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 any excess liquid with a clean tissue.
Screw the cap back onto the Otinum bottle.

Additional advice on administering Otinum:

Assistance from another person when administering the drops or using a mirror may make application easier.
Take care to avoid water entering the ear into which the medicine has been previously administered.
Do not share Otinum with other people.

Use of more than the recommended dose of Otinum
Overdose is not possible when the medicine is used as directed in 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, which may result in 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, take 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of the adverse effects listed below is unknown (cannot be determined from the available data).
Local hypersensitivity reactions (skin redness and itching).
In patients with perforation of the eardrum, use of this medicine may lead to hearing damage.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse 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 adverse effects helps to provide more information on the safety of using this medicine.

5. How to store Otinum

Do not store above 25°C.
Keep in the original packaging.
The medicine should be stored 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 sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Otinum contains

The active substance is choline salicylate. 1 g of 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 medicine is packed in an LDPE bottle with a dropper and a cap with a tamper-evident ring, placed in a cardboard box. The package contains 10 g of medicine.
For further information, please contact the responsible party or parallel importer:
Responsible entity in Lithuania, country of export:
SIA Meda Pharma, Mūkusalas 101, Riga LV-1004, Latvia
Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-959 Rzeszów
Parallel importer:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111 Street, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., Św. Teresy od Dzieciątka Jezus 111 Street, 91-222 Łódź
Authorization number in Lithuania, country of export: LT/1/94/1929/001
Parallel import authorization number: 197/14