Otinum

Package Leaflet: 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

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 the patient leaflet or as directed by the doctor.
• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, talk to a pharmacist.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or you feel worse after 3 days, contact your 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 used for the short-term treatment of inflammatory conditions of the external ear canal, characterized by pain, itching, and redness.
The medicine is also recommended for softening earwax before ear irrigation.
The active substance of Otinum ear drops is a salicylic acid derivative - choline salicylate.
Choline salicylate has local analgesic and anti-inflammatory effects when applied topically, reducing pain and inflammation in external ear canal inflammation. The glycerol in the medicine softens earwax, making it easier to remove. When administered locally into the ear, the medicine does not have a systemic effect.

2. Important information before using Otinum

When not to use Otinum

• if you are allergic (hypersensitive) to the active substance (choline salicylate), other salicylates (e.g., acetylsalicylic acid/aspirin), or any of the other ingredients of this medicine (listed in section 6);
• if you have bleeding or discharge from the ear;
• if you have severe ear pain with worsening hearing;
• if you have previously been diagnosed with eardrum damage (perforation or rupture);
• in children under 18 years of age.

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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., improper ear cleaning with cotton swabs), and medical procedures (e.g., improper ear irrigation due to earwax).

Warnings and precautions

Any ear pain is a reason to consult a doctor.
The medicine for the treatment of external ear canal inflammation can be used without consulting a doctor for a short period, no longer than 3 days. If there is no improvement or the symptoms worsen despite using Otinum in the recommended doses for 3 days, you should contact your doctor.
If additional symptoms occur, indicating a developing disease (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 hinder or delay their proper diagnosis.
You should inform your doctor about the use of Otinum.
The medicine contains a preservative - chlorobutanol.
Do 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

3. How to use Otinum

Always use this medicine exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist.
Otinum is for 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, talk to your doctor.
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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 a doctor's recommendation, do not use Otinum for more than 3 days.
• For softening hardened earwax before removal: usually 3 to 4 drops into the external ear canal every 12 hours for four days.

Elderly:
No dose adjustment is necessary.
Patients with liver or kidney function disorders:
No dose adjustment is necessary.

Instructions for using 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 is facing upwards.
• 3. Gently pull the earlobe (the lower part of the ear) away from your neck.
• 4. With the bottle upside down, press the bottle to administer 3-4 drops of the medicine into the affected ear.
• 5. For a few minutes, keep your head tilted so that the drops can flow into the ear canal.
• 6. Wipe away any excess liquid with a clean cloth.
• 7. Close the Otinum bottle.

Additional tips for using Otinum:

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

Using more than the recommended dose of Otinum

It is not possible to overdose on the medicine by administering it into the ear. Symptoms of overdose, which may occur after accidental oral ingestion of the medicine, include: disorientation, dizziness, excessive sweating, vomiting, ringing in the ears, and rapid breathing (hyperventilation). In the event of oral ingestion of very large doses of the medicine, central nervous system disorders may occur, including respiratory and circulatory disorders. If you have taken the medicine orally, seek medical attention immediately.

Missing a dose of Otinum

If you miss a dose, use it as soon as you remember. 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, 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 with the medicine, hearing loss may occur.
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Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
5.

How to store Otinum

Store below 25°C.
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 month.
Medicines should not be disposed of via wastewater or 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.
• The other ingredients are: glycerol, ethanol 96%, chlorobutanol, purified water.

What Otinum looks like and contents of the pack

The medicine is a polyethylene bottle with a dropper and screw cap, in a cardboard box.
The pack contains 10 g of the medicine.
For more detailed information, please 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., Przemysłowa 2, 35-959 Rzeszów

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Latvia, the country of export: 96-0162

Parallel import authorization number: 26/17 Date of approval of the leaflet: 13.01.2022

[Information about the trademark]
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