Otinum (Drops) Instructions for Use

Marketing Authorization Holder

Viatris Healthcare, GmbH (Germany)

Manufactured By

ICN Polfa Rzeszow, S.A. (Poland)

ATC Code

S02DA (Analgesics and anesthetics)

Active Substance

Choline salicylate (Rec.INN registered by WHO)

Dosage Form

Otinum

Ear drops 20%: dropper bottle 10 g

Dosage Form, Packaging, and Composition

Ear drops in the form of a transparent solution from colorless to slightly yellow in color, with a characteristic odor, free from foreign particles.

Excipients: glycerol – 0.13 g, ethanol 96% – 0.1 g, chlorobutanol hemihydrate – 0.005 g, purified water – up to 1 g.

10 g – polyethylene dropper bottles with a capacity of 10 ml (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of ear diseases; other drugs for the treatment of ear diseases; analgesics and anesthetics

Pharmacological Action

Choline salicylate is a derivative of salicylic acid.

When applied externally and topically, it has an anti-inflammatory and analgesic effect.

It has antimicrobial and antifungal activity.

Indications

For topical application to the mucous membranes of the oral cavity as an analgesic and anti-inflammatory agent in the treatment of periodontal diseases, damage to the mucous membrane, diseases occurring with an inflammatory reaction and pain; minor surgical interventions.

As part of complex therapy – multiform exudative erythema (including Stevens-Johnson syndrome).

For the symptomatic relief of ear pain in acute otitis media, chronic otitis media, external otitis, myringitis.

Softening of hardened earwax before the procedure of its removal from the ear.

ICD codes

Dosage Regimen

For ear pain, instill 3-4 drops into the external auditory canal 3-4 times daily.

For softening earwax, instill 3-4 drops into the affected ear twice daily for 4 consecutive days.

Prior to instillation, warm the bottle in your hands to avoid vestibular reaction.

Lie on your side with the affected ear upward.

Gently pull the auricle upward and backward to straighten the ear canal.

Instill the prescribed number of drops.

Remain in position for several minutes to ensure penetration.

Insert a cotton wool plug into the meatus.

The maximum duration of continuous treatment for ear pain is 10 days.

Do not use for more than 4 days for earwax softening without consulting a physician.

Discontinue use and consult a physician if symptoms persist or worsen.

Do not use if the eardrum is perforated or suspected to be perforated.

Adverse Reactions

Possible: allergic reactions.

In ear diseases use in patients with perforation of the eardrum may lead to hearing impairment.

Contraindications

Hypersensitivity to salicylates.

Depending on the dosage form used: complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis and intolerance to acetylsalicylic acid or other NSAIDs (including in history); violation of the integrity of the eardrum; pregnancy, breastfeeding period; children under 1 year of age.

With caution

Depending on the dosage form: allergic (“hay”) rhinitis, polyps of the mucous membrane of the nasal passages; pregnancy, breastfeeding period; children under 1 year of age.

Use in Pregnancy and Lactation

Use with caution during pregnancy and breastfeeding according to indications, in recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the prescribing information for choline salicylate preparations regarding contraindications for use during pregnancy and breastfeeding for specific dosage forms.

Pediatric Use

Can be used in children according to indications, in age-appropriate recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the prescribing information for choline salicylate preparations regarding contraindications for use in children of different ages for specific dosage forms of choline salicylate.

In children under 1 year of age, the use of this agent is possible only under medical supervision.

Special Precautions

Salicylic acid derivatives entering the middle ear through a damaged eardrum can cause hearing impairment or deafness.

In this regard, Choline salicylate should not be used without a preliminary examination by an otorhinolaryngologist and without a doctor’s prescription.

Drug Interactions

With simultaneous use, Choline salicylate enhances the effect of other anti-inflammatory and analgesic agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.