Flotto ear drops bottle 15 ml

Instructions for Flotto ear drops bottle 15 ml

Composition

active ingredients: 1 ml of solution contains phenazone 45.5 mg and lidocaine hydrochloride 11.4 mg;

excipients: sodium thiosulfate, ethanol 96%, glycerin, sodium hydroxide, purified water.

Dosage form

Ear drops.

Main physicochemical properties: practically transparent solution from colorless to slightly brownish-yellow, practically free from mechanical inclusions.

Pharmacotherapeutic group

Means used in otology. ATX code S02D A30.

Pharmacological properties

Pharmacodynamics

Combined drug for local use in otology with pronounced analgesic and anti-inflammatory effects, which are due to the synergistic 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 active components is not expected (in the absence of damage to the eardrum).

The drug's effect (reducing eardrum pain and reducing inflammation) begins 5 minutes after instillation. The pain syndrome almost completely disappears after 15-30 minutes.

Indication

Local symptomatic treatment and analgesia for middle ear diseases with an intact eardrum, such as:

Congestive otitis media in the acute period; edematous viral otitis (post-influenza); barotraumatic otitis.

The medicine is intended for use in adults and children aged 1 month and over.

Contraindication

Hypersensitivity to the components of the drug or to amide local anesthetics. Infectious or traumatic damage (perforation) of the eardrum.

Special safety precautions

The integrity of the tympanic membrane should be checked before administering the drug. If the tympanic membrane is perforated, administration of the drug may result in contact of the drug with the structures of the middle ear, which may cause adverse reactions in these tissues.

It should be noted that the drug may affect the result of an anti-doping test.

Interaction with other medicinal products and other types of interactions

No data.

Ability to influence reaction speed when driving vehicles or other mechanisms

There is no data on the effect of the drug on the reaction rate when driving vehicles or working with other mechanisms.

Use during pregnancy or breastfeeding

If necessary, Flotto can be used during pregnancy or breastfeeding after consulting a doctor.

Method of administration and doses

Adults and children over 1 month of age should instill 4 drops into the external auditory canal 2-3 times a day. The course of treatment should not exceed 10 days. If there is no improvement, review the treatment.

To prevent discomfort from contact of the skin of the ear canal with the cold solution, the bottle should be warmed in the hand before using the medicine. The bottle should be closed after each use.

Children

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

Used for children aged 1 month and older as prescribed by a doctor.

Overdose

When using the drug in recommended doses, overdose is unlikely.

Adverse reactions

Reported adverse reactions are listed according to system organ class.

From the organs of hearing and balance: local reactions: allergic reactions, including irritation, hyperemia of the external auditory canal, itching, skin rashes.

Expiration date

3 years.

After opening the bottle, the drug should be used within 1 month.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging. Keep out of the reach of children.

Packaging

15 ml of solution in a polymer dropper bottle. 1 dropper bottle in a cardboard box.

Vacation category

Without a prescription.

Producer

K. O. Romfarm Company S. R. L., Romania.

Location of the manufacturer and its business address

Eroilor St. No. 1A, Otopeni, Ilfov, 075100, Romania