Flotto

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLOTTO (FLOTTO)

Composition:

Active substances: phenazone, lidocaine hydrochloride;

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

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

Pharmaceutical form. Ear drops.

Main physicochemical properties: practically clear solution, ranging from colorless to slightly brownish-yellow, practically free from mechanical particles.

Pharmacotherapeutic group. Medicinal products used in otology. ATC code S02DA30.

Pharmacological properties.

Pharmacodynamics.

A combined medication for topical use in otology with pronounced analgesic and anti-inflammatory effects, resulting from 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 tympanic membrane damage).

The effect of the medication (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 and pain relief in middle ear diseases with an intact tympanic membrane, such as:

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

The medicinal product is intended for use in adults and children aged 1 month and older.

Contraindications.

Hypersensitivity to the components of the drug or to amide-type local anesthetics. Infectious or traumatic injury (perforation) of the tympanic membrane.

Special precautions.

Before prescribing the drug, the integrity of the tympanic membrane should be verified. If the tympanic membrane is perforated, administration of the drug may result in contact of the drug with structures of the middle ear, leading to adverse reactions in these tissues.

It should be noted that the drug may affect the results of anti-doping tests.

Interaction with other medicinal products and other forms of interactions.

No data available.

Special precautions for use.

Use during pregnancy or breastfeeding

Flotto may be used during pregnancy or breastfeeding if necessary, after consultation with a physician.

Ability to affect reaction rate when driving vehicles or operating machinery

There are no data on the effect of the drug on reaction rate when driving vehicles or operating machinery.

Method of administration and dosage.

For adults and children aged 1 month and older: instill 4 drops into the external auditory canal 2–3 times daily. The treatment course should not exceed 10 days. If no improvement occurs, reassess the treatment.

To avoid discomfort caused by contact of the cold solution with the skin of the auditory canal, warm the bottle in the hand before administering the medication. The bottle must be closed after each use.

Children.

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

Use in children aged 1 month and older only as directed by a physician.

Overdose.

Overdose is unlikely when the drug is used at recommended doses.

Side effects.

Reported side effects are listed according to system organ classes.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions during the post-marketing period of the medicinal product is important. It enables continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals are obliged to report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

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

Storage conditions.

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

Packaging.

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

Classification by prescription. Over-the-counter.

Manufacturer

Rompharm Company S.R.L., Romania

Manufacturer’s address and location of its operations.

Strada Eroilor No. 1A, Otopeni, Ilfov County, Building Rompharm 1, Rompharm 2, 075100, Romania

Marketing Authorisation Holder.

Delta Medical Promotions AG, Switzerland.

Address of the Marketing Authorisation Holder and/or its representative.

Othmarstrasse 26, Zurich CH-8001, Switzerland.