Droplex

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DROPLEKS (DROPLEKS)

Composition:

Active substances: phenazone, lidocaine hydrochloride;

1 ml of solution contains phenazone 45.52 mg and lidocaine hydrochloride 11.38 mg;

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

Pharmaceutical form. Ear drops, solution.

Main physico-chemical properties: clear, colorless or slightly brownish-yellow solution.

Pharmacotherapeutic group. Medicinal products used in otology. Analgesics and anesthetics in combination. ATC code S02DA30.

Pharmacological properties.

Pharmacodynamics.

The medicinal product is a combination of two active ingredients: phenazone and lidocaine.

Phenazone is a pyrazolone derivative with analgesic and anti-inflammatory properties. Lidocaine is an amide-type local anesthetic. The combination of phenazone and lidocaine provides a synergistic analgesic/anti-inflammatory effect.

Pharmacokinetics.

Absorption of any component of the medicinal product through the skin has not been studied. Absorption is negligible. Systemic absorption of this solution is not expected (in the absence of tympanic membrane damage).

The effect of the medicinal product (reduction of tympanic membrane pain and inflammation) begins within five 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 for:

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

Contraindications.

• Hypersensitivity to the active substances, to other components of the medicinal product, or to amide-type local anesthetic medicinal products.
• Perforation of the tympanic membrane of traumatic or infectious origin (see section "Special precautions for use").

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 using the medicinal product, the integrity of the tympanic membrane should be checked (as a precautionary measure). If there is a destruction of the tympanic membrane, administration of the medicinal product into the ear may lead to its contact with the structures of the middle ear, causing adverse reactions in these tissues.

The medicinal product contains an active ingredient which may lead to a positive result in an anti-doping test.

Use during pregnancy or breastfeeding.

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

When used correctly, phenazone and lidocaine do not penetrate into breast milk. If necessary, the medicinal product may be used during pregnancy or breastfeeding after consultation with a physician.

Ability to influence reaction rate while driving or operating machinery.

The medicinal product does not affect the reaction rate when driving or operating machinery.

Method of Administration and Dosage

The medicinal product is intended for administration into the external auditory canal.

For children from 1 month of age and adults: instill 4 drops 2–3 times daily into the external auditory canal of the affected ear. The treatment course should not exceed 10 days. After this period, the treatment should be re-evaluated.

To avoid discomfort due to contact of the cold solution with the skin of the ear canal, warm the bottle in your hands before use.

Children

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

The medicinal product may be used in children from 1 month of age after consultation with and upon recommendation by a physician.

Overdose

Overdose has not been observed when the medicinal product is used at the recommended dosage.

Side effects.

The reported side effects are listed according to system organ classes.

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

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

After opening the bottle, the medicinal product can be used for up to 28 days.

Storage conditions.

Store at temperatures not exceeding 25 °C, in a place inaccessible to children.

Packaging.

15 ml in polymer dropper bottles; 1 dropper bottle in a cardboard box.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

UORLД MEDICINE ILAC SAN. VE TIC. A.S. /
WORLD MEDICINE ILAC SAN. VE TIC. A.S.

Manufacturer's address and location of operations.

15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey /
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.

Marketing Authorization Holder.

LLC "WORLD MEDICINE", Ukraine /
WORLD MEDICINE, LLC, Ukraine.