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

Before Using the Medication, You Should Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

• This Medication 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 Necessary.
• If You Need Advice or Additional Information, You Should Consult a Pharmacist.
• If the Patient Experiences any Undesirable Effects, Including any Possible Undesirable Effects not Listed in the Leaflet, You Should Inform the Doctor, Pharmacist, or Nurse. See Section 4.
• If There is no Improvement or the Patient Feels Worse after 3 Days, You Should Contact 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 Undesirable Effects
• 5. How to Store Otinum?
• 6. Package Contents and Other Information

1. What is Otinum and What is it Used for?

Otinum is a Medication Indicated for Short-Term Use in Inflammatory Conditions of the External Auditory Canal Characterized by Pain, Itching, and Redness.
The Medication is also Recommended for Softening Earwax Before Ear Irrigation.
The Active Substance of Otinum Ear Drops is a Derivative of Salicylic Acid – Choline Salicylate.
Choline Salicylate Used Topically has Analgesic and Anti-Inflammatory Properties. This Reduces Pain and Inflammation in the Course of External Auditory Canal Inflammation.
The Glycerol Contained in the Medication Softens Earwax in the Ear, Making it Easier to Remove.
After Local Administration to the Ear, the Medication does not Have a Systemic Effect.

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 any of the Other Components of this Medication (Listed in Section 6);
• If the Patient has Bleeding or Discharge from the Ear;
• If the Patient Experiences Severe Ear Pain with Worsening Hearing;
• If the Patient has Previously been Diagnosed with Eardrum Damage (Perforation or Disruption of its Continuity);
• 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 Cotton Swabs), and Medical Reasons (e.g., Improper Ear Irrigation Due to Earwax).

Warnings and Precautions

Any Ear Pain is a Reason to Consult a Doctor.
The Medication Used to Treat Inflammatory Conditions of the External Auditory Canal Without Consulting a Doctor can be Used for a Short Period, not 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 a Doctor.
If Additional Symptoms Appear, Indicating a Developing Disease Process (e.g., Fever, Malaise, Weakness, Dizziness, Discharge from the Ear), You Should Contact a Doctor.
In the Event of Recurrence of the Disease, the Use of Otinum Should be Decided by a Doctor.
Otinum may Mask Symptoms of Other Ear Diseases and Make their Proper Diagnosis Difficult or Delayed.
You Should Inform the Doctor About the Use of the Medication.
The Medication Contains a Preservative – Chlorobutanol Hemihydrate.
Otinum Should not be Used in a Manner Inconsistent with 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 Medications

You Should Tell the Doctor or Pharmacist About all Medications Currently Used by the Patient or Recently Used, as well as Medications the Patient Plans to Use. This Applies to Over-the-Counter Medications as Well.
The Medication is Used Topically 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 the Patient is Pregnant or Breastfeeding, Suspects She may be Pregnant, or Plans to Have a Child, She Should Consult a Doctor or Pharmacist Before Using this Medication.

Driving and Operating Machinery

The Medication does not Affect the Ability to Drive Vehicles or Operate Machinery.

3. How to Use Otinum?

This Medication Should Always be Used Exactly as Described in the Patient Leaflet or as Directed by a Doctor or Pharmacist. In Case of Doubt, You Should Consult a Doctor or Pharmacist.
Otinum is Used Exclusively Topically, in the Ear.
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 Auditory Canal Inflammation: Usually 3 to 4 Drops into the External Auditory Canal Every 6 to 8 Hours.Without a Doctor's Recommendation, Otinum Should not be Used 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 4 Days.Elderly Patients: No Need to Change the Dosage.

Patients with Liver and (or) Kidney Function Disorders:
No Need to Change the Dosage.

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 Affected Ear is Facing Upwards.
• 3. Gently Pull the Earlobe (Lower Part of the Auricle) Away from the Neck.
• 4. With the Bottle Upside Down, Pressing it on Both Sides, Administer 3-4 Drops of the Medication into the Affected Ear.
• 5. For a Few Minutes, Keep Your Head Tilted so that the Drops can Flow into the Auditory Canal.
• 6. Wipe Excess Liquid with a Clean Tissue.
• 7. Close the Otinum Bottle.

Additional Tips for Administering Otinum:

• 1. Having Someone Assist You with Dripping the Medication into the Ear or Using a Mirror can Facilitate Administration.
• 2. You Should be Careful not to Get Water into the Ear After Administering the Medication.
• 3. You Should not Share Otinum with Other People.

Using a Higher than Recommended Dose of Otinum

It is Impossible to Overdose on the Medication by Administering it into the Ear.
Symptoms of Overdose that may Occur after Accidental Oral Ingestion of the Medication Include:
Disorientation, Dizziness, Excessive Sweating, Vomiting, Ringing in the Ears, and Too Rapid Breathing (Hyperventilation). In the Event of Ingesting Very Large Doses of the Medication, Central Nervous System Disorders may Occur, Including Breathing and Circulatory Disorders.
In the Event of Oral Ingestion of the Medication, You Should Immediately Consult a Doctor.

Missing a Dose of Otinum

In the Event of Missing a Dose of the Medication at the Designated Time, You Should Administer it as Soon as Possible.
However, if the Time for the Next Dose is Approaching, You Should Omit the Missed Dose. You Should not Use a Double Dose to Make up for the Missed Dose.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although not Everybody will Experience them.
The Frequency of the Following Undesirable Effects is Unknown (Cannot be Determined from Available Data).
Local Allergic Reactions (Redness and Itching of the Skin).
In Patients with Eardrum Perforation During the Use of the Medication, Hearing Loss may Occur.

Reporting Undesirable Effects

If You Experience any Undesirable Effects, Including any Undesirable Effects not Listed in the Leaflet, You Should Inform the Doctor, Pharmacist, or Nurse. Undesirable 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 Undesirable Effects will Allow for More Information to be Collected on the Safety of the Medication.

5. How to Store Otinum?

The Medication Should be Stored in a Place Invisible and Inaccessible to Children.
Do not Store at a Temperature Above 25°C. Store in the Original Packaging.
Do not Use this Medication after the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of in Sewers or Household Waste Containers. You Should Ask the Pharmacist how to Dispose of Medications that are no Longer Used. This will Help Protect the Environment.

6. Package Contents and Other Information

What Otinum Contains

• The Active Substance of the Medication is Choline Salicylate. 1 g of the Ear 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 What the Packaging Contains

The Medication Packaging is a 10 ml PE Bottle with a Dropper and a Screw Cap with a Guarantee Ring, in a Cardboard Box. The Packaging Contains 10 g of the Medication.

To Obtain More Detailed Information, You Should Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Lithuania, the Country of Export:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15, Dublin, Ireland

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
Lithuanian, Country of Export Marketing Authorization Number:LT/1/94/1929/001
Parallel Import License Number:153/15

Date of Approval of the Leaflet: 27.02.2025

[Information about the Trademark]