Flotto ear drops solution, dropper bottle 15 ml

Pharmacological properties

Pharmacodynamics. A combined product for local use in otology with a pronounced analgesic and anti-inflammatory effect, caused by the synergism of action of its components. Phenazone is a pyrazolone derivative with analgesic and anti-inflammatory properties. Lidocaine is a local anesthetic of the amide group.

Pharmacokinetics. Systemic absorption of the active components is not expected (in the absence of damage to the tympanic membrane). The action of the product (reduction of soreness of the tympanic membrane and reduction of inflammation) begins 5 minutes after instillation. Pain syndrome almost completely disappears after 15–30 minutes.

Indications

Local symptomatic treatment and pain relief in diseases of the middle ear with an intact tympanic membrane, such as:

• Congestive otitis media in the acute period;
• Edematous viral otitis (post-influenza);
• Barotraumatic otitis.

The medicinal product is intended for use in adults and children over 1 month of age.

Administration

Adults and children over 1 month of age: instill 4 drops into the external auditory canal 2–3 times a day. The course of treatment should not exceed 10 days. If improvement does not occur, treatment should be reviewed.

To prevent unpleasant sensations resulting from contact of the skin of the auditory canal with a cold solution, the bottle should be warmed in the hand before use. The bottle must be closed after each use.

Contraindications

Hypersensitivity to the components of the product or to amide local anesthetic medicinal products. Infectious or traumatic damage (perforation) of the tympanic membrane.

Side effects

Adverse reactions that have been reported are listed according to system organ classes.

Ear and labyrinth disorders: local reactions: allergic reactions, including irritation, hyperemia of the external auditory canal, itching, skin rash.

Special instructions

Before prescribing the product, the integrity of the tympanic membrane should be checked. If the tympanic membrane is perforated, administration of the product may lead to contact of the product with the structures of the middle ear, which will cause adverse reactions in these tissues.

It should be taken into account that the product may affect the result of an anti-doping test.

Use during pregnancy and breastfeeding

If necessary, the product Flotto may be used during pregnancy and breastfeeding after consultation with a physician.

Children

There are no data on the safety and efficacy of the product in children under 1 month of age.

Used in children from 1 month of age as prescribed by a physician.

Ability to affect reaction speed when driving vehicles or operating other mechanisms. There are no data regarding the effect of the product on the ability to drive vehicles or operate other mechanisms.

Interactions

No data.

Overdose

When using the product at the recommended doses, overdose is unlikely.

Storage conditions

At a temperature not exceeding 25 °C.