Otirelax (Drops) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

S02DA30 (Analgesics and anesthetics in combination)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Phenazone (Rec.INN registered by WHO)

Dosage Form

Otirelax

Ear drops 40 mg+10 mg/1 g: dropper bottle 15 ml 1 pc.

Dosage Form, Packaging, and Composition

Ear drops as a clear, colorless or slightly yellowish solution.

Excipients : sodium thiosulfate pentahydrate – 1 mg, ethanol 96% – 200 mg, purified water – 20 mg, sodium hydroxide solution 1M – to pH 5.5±0.2, glycerol – to 1 g.

15 ml (17.1 g) – polyethylene dropper bottles with a capacity of 15 ml (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and local anesthetic action for topical use in ENT practice

Pharmacotherapeutic Group

Topical anti-inflammatory agent

Pharmacological Action

A combined drug that has anti-inflammatory, local anesthetic, and analgesic effects.

Indications

Use for local symptomatic treatment and pain relief in adults and children, including newborns.

• Acute otitis media during the inflammation period.
• Otitis as a complication after influenza.
• Barotraumatic otitis.

ICD codes

Dosage Regimen

Instill 4 drops into the external auditory canaltwo to three times daily.

Ensure the solution reaches the ear canal by gently pulling the auricle upwards and backwards for adults, or downwards and backwards for children.

Limit the course of treatment to a maximum of 10 days. Do not exceed the recommended dosage or duration of use.

Adverse Reactions

Primarily local reactions at the application site.

These may include allergic reactions, irritation, redness (hyperemia), or a transient burning sensation.

Discontinue use immediately and consult a physician if any signs of hypersensitivity or severe local reaction occur.

Drug Interactions

No specific drug interactions have been reported for this topical formulation.

Concurrent use with other ototoxic medications should be approached with caution, especially if tympanic membrane integrity is compromised.

Inform your physician about all other medications you are using before starting treatment.

Contraindications

Do not use under the following conditions.

• Hypersensitivity to lidocaine, phenazone, or any other component of the drug.
• Known mechanical damage to the tympanic membrane or suspected perforation.

Verify tympanic membrane integrity prior to administration to prevent contact with middle ear structures.

Overdose

Overdose from topical otic administration is unlikely due to low systemic absorption.

Excessive instillation may lead to increased local adverse effects such as irritation.

In case of accidental ingestion, systemic effects of lidocaine and phenazone may occur; seek immediate medical attention and provide symptomatic and supportive care.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding according to indications and provided the tympanic membrane is intact.

Pediatric Use

Can be used in infants.

Special Precautions

Before starting to use the drug, it is necessary to ensure the integrity of the tympanic membrane.

In case of use with a perforated tympanic membrane, the drug may come into contact with the middle ear organs and lead to complications.

Information for athletes: contains an active component that can give a positive reaction during doping control.

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.