Evkaphilipt®

INSTRUCTION for medical use of the medicinal product EUCAPHYLIPT® (EUCAPHYLIPT)

Composition:

Active substance: tincture (1:10) of eucalyptus leaf (Eucalypti folium) (extractant – 96% ethanol);

1 ml of the preparation contains 0.25 ml of tincture (1:10) of eucalyptus leaf (Eucalypti folium) (extractant – 96% ethanol), calculated as cineole – not less than 0.05 mg;

Excipient: isopropyl myristate.

Pharmaceutical form. Spray.

Main physicochemical properties: green to dark green liquid. A slight sediment may form during storage.

Pharmacotherapeutic group.
Preparations used in throat diseases. Antiseptics. ATC code R02A A20.

Pharmacological properties.

The tincture contains tannins, ellagic acid, flavonoids, resins, wax, and essential oil, which includes various terpenoid compounds particularly active against Gram-positive and Gram-negative microorganisms, exerting a detrimental effect on fungi and protozoa. Eucalyptus suppresses the growth of Staphylococcus aureus, Escherichia, tuberculous mycobacteria, trichomonads, and Entamoeba histolytica. The main component of the essential oil is cineole, a monocyclic terpene. The tincture exerts antiseptic, anti-inflammatory, and disinfectant actions, which are due to the oxidizing effect of the monocyclic terpene cineole and the anti-inflammatory influence associated with virtually all the biologically active substances present in its composition.

The preparation demonstrates antibacterial activity against staphylococci.

Clinical characteristics.

Indications.

Inflammatory diseases of the upper respiratory tract, nasopharynx, and oral cavity (tracheitis, laryngitis, pharyngitis, gingivitis, stomatitis), skin injuries (including infected wounds).

Contraindications.

Bronchial asthma, bronchospasm. Individual hypersensitivity to the drug.

Inflammatory diseases of the gastrointestinal tract and biliary pathways. Severe liver disease.

Interaction with other medicinal products and other types of interactions.

Not established.

Special precautions.

Consult a physician before starting use.

Use during pregnancy or breastfeeding.

The efficacy and safety of the medicinal product during pregnancy or breastfeeding have not been studied; therefore, the product should not be used in these patient groups.

Ability to affect reaction rate when driving or operating machinery.

When using the spray to treat upper respiratory tract disorders, patients should refrain from driving vehicles or operating potentially hazardous machinery.

Method of Administration and Dosage.

Eukafilypt® is intended for topical use. Before the first use, and also if the Eukafilypt® spray has not been used for a prolonged period (at least 1 week), press the spray pump several times to release the spray into the air to ensure uniform atomization. Shake well before use. In case of inflammatory conditions of the upper respiratory tract, nasopharynx, and oral cavity (tracheitis, laryngitis, pharyngitis, gingivitis, stomatitis), adults should apply the preparation locally by spraying into the oral cavity, administering 3–4 actuations 3–4 times daily for 3–4 days. For treatment of skin injuries, moisten a gauze pad with the preparation and leave it on the skin or mucous membranes for 15–20 minutes. Perform this procedure twice daily. Continue treatment until therapeutic effect is achieved. The duration of treatment should be determined by a physician.

Children.

There is no experience with the use of this preparation in children.

Overdose.

Not established.

Side effects.

Nausea, vomiting, and diarrhea. In case of hypersensitivity to the drug, allergic reactions may occur (urticaria, skin redness and rashes, itching, Quincke's edema), sometimes contact dermatitis (in the lip area). If pronounced reactions occur, the use of the drug should be discontinued.

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

Shelf life. 2 years.

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

Storage conditions.

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

Keep out of reach of children.

Packaging.

20 ml in a glass bottle with a spray pump and rotary nozzle or 50 ml in a glass bottle with a spray pump and throat nozzle.

Prescription status. Over-the-counter.

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA"

Manufacturer's address and place of business.

Ukraine, 61010, Kharkiv region, city of Kharkiv, Gordeyenkivska Street, building 1.