Otinum

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Otinum

0.2 g/g (200 mg/g), ear drops, solution

Choline salicylate

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or 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 packaging 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 flushing the external auditory canal.
The active substance of Otinum ear drops is a salicylic acid derivative – choline salicylate.
Choline salicylate has analgesic and anti-inflammatory properties when used locally, which reduces pain and inflammation in the course of external otitis.
The 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

• in people under 18 years of age.

Eardrum perforation may be indicated by: severe 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 procedures (e.g., improper ear flushing due to earwax).

Warnings and precautions

Any ear pain is a reason to consult a doctor.
The medicine for the treatment of external otitis without consulting a doctor can be used for a short period, no longer than 3 days. If there is no improvement or worsening of symptoms despite using Otinum in the recommended doses for 3 days, you should contact your doctor.
If additional symptoms appear, indicating a developing disease process (e.g., fever, malaise, weakness, dizziness, discharge from the ear), you should contact your doctor.
In the event of recurrence of the disease, the use of Otinum should be decided by a doctor.
Otinum may mask the symptoms of other ear diseases and make their proper diagnosis difficult or delayed.
You should inform your doctor about the use of Otinum.
The medicine contains a preservative – chlorobutanol.
You must not use Otinum 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as medicines you plan to take. This also applies to over-the-counter medicines.
The medicine is used locally 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

The medicine does not affect the ability to drive 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 a doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
Otinum is for local 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, you should consult a 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.Without a doctor's recommendation, you should not use Otinum for more than 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 four days.Elderly patients: No dose adjustment is necessary.

Patients with liver and/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 up.
• 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 ear canal.
• 6. Wipe off excess liquid with a clean cloth.
• 7. Close the Otinum bottle.

Additional tips for administering Otinum:

• 1. Having someone help you with ear drops 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 others.

Using a higher dose of Otinum than recommended

It is impossible to overdose on the medicine by administering it to the ear.
Symptoms of overdose that may occur after accidental oral ingestion of the medicine include:
a state of disorientation, dizziness, excessive sweating, vomiting, ringing in the ears, and too rapid breathing (hyperventilation). In the event of taking very large doses of the medicine orally, there may be disorders of the central nervous system, including breathing and circulation disorders.
In the event of oral ingestion of the medicine, you should immediately consult a doctor.

Missing a dose of Otinum

If you miss a dose of the medicine at the scheduled time, you should take it as soon as possible.
However, if it is almost time for the next dose, you should skip the missed dose. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Otinum 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 treatment, there may be hearing damage.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Otinum

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the immediate packaging and the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Otinum contains

• The active substance of the medicine is choline salicylate. 1 g of ear drops contains 200 mg of choline salicylate.
• The other ingredients are: glycerol, ethanol 96%, chlorobutanol, purified water.

What Otinum looks like and what the packaging contains

The packaging of the medicine is a 10 g polyethylene bottle with a dropper, in a carton. The packaging contains 10 g of the medicine.

To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

SIA Meda Pharma
Mūkusalas 101
Riga LV-1004
Latvia

Manufacturer:

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Poland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:96-0162
Parallel import authorization number:228/17
Date of leaflet approval: 12.05.2022
[Information about the trademark]