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 a 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 a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or you feel worse after 3 days, talk to a 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.
Otinum is also recommended for softening earwax before ear irrigation.
The active substance of Otinum ear drops, solution is a salicylic acid derivative - choline salicylate.
Choline salicylate has local analgesic and anti-inflammatory properties when applied topically. This reduces pain and inflammation in the external ear canal. The glycerol in the medicine softens earwax, making it easier to remove. After local application to the ear, the medicine does not have a systemic effect.

2. Important information before using Otinum

When not to use Otinum?

• in children under 18 years of age.

Signs of eardrum perforation may include: 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. Causes of eardrum damage (perforation) include infections, injuries (e.g., after improper ear cleaning with cotton swabs), and medical procedures (e.g., ear irrigation due to earwax).

Warnings and precautions

Any ear pain is a reason to consult a doctor.
Otinum can be used for the short-term treatment of external ear canal inflammation without consulting a doctor, but not for more than 3 days. If there is no improvement or if symptoms worsen despite using Otinum for 3 days as recommended, consult a doctor.
If additional symptoms occur, indicating a developing disease process (e.g., fever, malaise, weakness, dizziness, discharge from the ear), consult a doctor.
In case of recurrence of the disease, the use of Otinum should be decided by a doctor.
Otinum may mask symptoms of other ear diseases and hinder or delay their proper diagnosis.
Inform your doctor about using Otinum.
Otinum contains a preservative - chlorobutanol hemihydrate.
Do not use Otinum contrary to the indications listed in the leaflet or by 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 local effects.

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 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, talk to a 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 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 treated ear is facing upwards.
• 3. Gently pull the earlobe (lower part of the ear) away from your neck.
• 4. Invert the opened Otinum bottle and press it 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 any excess liquid with a clean tissue.
• 7. Close the Otinum bottle.

Additional advice on using 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 using the medicine.
• 3. Do not share Otinum with others.

Using more Otinum than recommended

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 case of oral ingestion of very large doses of the medicine, central nervous system disorders may occur, including breathing and circulation problems. If you have taken the medicine orally, seek medical help 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 your 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, hearing loss may occur.

Reporting side effects

If you get any side effects, talk to a 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
Al. Jerozolimskie 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

Do not store above 25°C.
Store in the original package.
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. 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 is a LDPE bottle with a dropper and a screw cap with a tamper-evident ring, in a cardboard box. The pack contains 10 g of the medicine.
For more detailed information, contact the marketing authorization holder or the parallel importer:

Marketing authorization holder in Lithuania, 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

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
Lithuanian, the country of export, authorization number: LT/1/94/1929/001

Parallel import authorization number: 197/14

Date of leaflet approval: 10.05.2024

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