Anaesthokap (Drops) Instructions for Use

Marketing Authorization Holder

Iris, LLC (Russia)

Manufactured By

YUGPHARM, LLC (Russia)

ATC Code

S02DA30 (Analgesics and anesthetics in combination)

Active Substances

Phenazone (Rec.INN registered by WHO)

Lidocaine (Rec.INN registered by WHO)

Dosage Form

Anaesthokap

Ear drops 10 mg/g+40 mg/g

Dosage Form, Packaging, and Composition

Ear drops

15 ml – dropper bottles – cardboard packs – Over-the-Counter

Clinical-Pharmacological Group

A drug with anti-inflammatory and local anesthetic action 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

A combined drug with anti-inflammatory, local anesthetic, and analgesic action.

Indications

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

• Apply for conditions such as acute otitis media during the inflammation period, otitis as a complication after influenza, and barotraumatic otitis.

ICD codes

Dosage Regimen

Instill the solution into the external auditory canal while the patient is lying on their side.

Administer a dose of 4 drops into the affected ear.

Apply the drops 2-3 times per day at regular intervals.

Gently press the tragus several times after instillation to facilitate penetration.

Remain in the lateral position for several minutes following administration.

Warm the bottle to body temperature by holding it in your hand before use to prevent vestibular reactions.

Limit the total course of treatment to a maximum of 10 days.

Discontinue use if symptoms persist beyond this duration and consult a physician.

Avoid contact of the dropper tip with the ear, fingers, or any other surfaces to prevent contamination.

Adverse Reactions

Monitor for local reactions at the application site.

These may include allergic reactions, irritation, and hyperemia (redness).

Contraindications

• Do not use in patients with a known hypersensitivity (allergy) to phenazone, lidocaine, or any other component of the drug.

• Strictly avoid use in the presence of mechanical damage to the eardrum (perforated tympanic membrane).

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding according to indications and provided the eardrum 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 eardrum.

If used with a perforated eardrum, the drug may come into contact with the middle ear structures and lead to complications.

Information for athletes: contains an active component that may 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.