Ototon

INSTRUCTIONS for medical use of the medicinal product OTOFEN® (OTOFEN)

Composition:

Active substances: phenazone, lidocaine hydrochloride;

1 g of drops contains phenazone equivalent to 100% dry substance 0.04 g, lidocaine hydrochloride equivalent to 100% anhydrous substance 0.01 g;

Excipients: sodium thiosulfate, ethanol 96%, glycerol, purified water.

Pharmaceutical form. Ear drops.

Main physicochemical properties: clear, colorless or slightly yellowish liquid with a characteristic alcoholic odor.

Pharmacotherapeutic group. Medicinal products used in otology. ATC code S02D A30.

Pharmacological properties.

Pharmacodynamics.

Ototon**®** is a combination of two active ingredients: phenazone and lidocaine.

Phenazone: a pyrazolone derivative with analgesic and anti-inflammatory properties.

Lidocaine: a local anesthetic of the amide group. The combination of phenazone and lidocaine produces a synergistic analgesic/anti-inflammatory effect.

Pharmacokinetics.

Absorption of any component of the drug through the skin has not been studied. Absorption is nearly negligible.

Systemic absorption of this solution is not expected (in the absence of tympanic membrane damage).

The drug's effect (reduction of tympanic membrane pain and inflammation) begins within 5 minutes after instillation. Pain syndrome almost completely disappears within 15–30 minutes.

Clinical characteristics.

Indications.

Local symptomatic treatment of certain painful conditions of the middle ear with intact tympanic membrane in children from 1 month of age and adults, namely:

• acute otitis media;
• post-viral flaccid otitis (post-influenzal);
• barotraumatic otitis.

Contraindications.

Hypersensitivity to the active substances, to any component of the medicinal product or to amide-type local anesthetics.

Perforation of the tympanic membrane of traumatic or infectious origin (see section "Special precautions").

Interaction with other medicinal products and other forms of interaction.

Currently, there are no data regarding the possibility of clinically significant interactions.

Special precautions for use

Before any application of the medicinal product, the integrity of the tympanic membrane should be checked (as a precautionary measure). If there is a perforation of the tympanic membrane, instillation of the medicinal product into the ear may result in contact of the active substances with structures of the middle ear, potentially causing adverse reactions in these tissues.

It should be noted that the medicinal product contains an active ingredient which may lead to a positive result in anti-doping tests.

Use during pregnancy or breastfeeding

There are no expected consequences of using the medicinal product during pregnancy, since systemic exposure to phenazone and lidocaine is negligible.

Under normal conditions of use, phenazone and lidocaine do not penetrate into breast milk. If necessary, Ototon® may be used during pregnancy or breastfeeding after consultation with a physician.

Ability to influence reaction speed when driving or operating machinery

The medicinal product does not affect the ability to drive or operate potentially hazardous machinery.

Dosage and Administration.

For children aged 1 month and older, and adults: instill 4 drops into the external auditory canal experiencing pain, 2–3 times daily. Treatment duration should not exceed 10 days. After this period, treatment should be re-evaluated.

To avoid discomfort caused by contact of the skin of the ear canal with cold solution, warm the bottle in your hand before using the medication. Then unscrew the cap from the bottle and screw the dropper onto the bottle. Invert the bottle and instill 4 drops by gently pressing the central part of the dropper. After use, tightly replace the white cap on the dropper and return the bottle to its packaging.

Children.

There are no safety and efficacy data for the use of Ototon® in children under 1 month of age.

Use in children aged 1 month and older should be after consultation with and upon recommendation by a physician.

Overdose.

No cases of overdose have been observed when the product was used at the recommended dosage.

Side effects.

The reported side effects are listed below by system organ classes.

Auditory and vestibular system side effects: local reactions – allergic reactions including irritation, hyperemia of the external auditory canal, itching, skin rashes.

Shelf life: 2 years.

Shelf life after opening the bottle: 1 month.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

16 g in a bottle. 1 bottle per carton.

Prescription status. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.