EUCALYPTI TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EUCALYPTUS TINCTURE

Composition:

Active substance: Eucalyptus leaf tincture (Tinctura Eucalypti) (1:5) (extractant – ethanol 70 %);

1 bottle contains Eucalyptus leaf tincture (Tinctura Eucalypti) (1:5) (extractant – ethanol 70 %) – 25 ml or 50 ml.

Pharmaceutical form. Tincture.

Main physicochemical properties: clear greenish-brown liquid with a characteristic odor. Sediment may form during storage.

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

Pharmacological properties.

Pharmacodynamics.

Eucalyptus tincture contains tannins, ellagic acid, flavonoids, resins, wax, and essential oil, which includes various terpene compounds, particularly active against Gram-positive and Gram-negative microorganisms, exerting detrimental effects on fungi and protozoa. Eucalyptus inhibits the growth of Staphylococcus aureus, Escherichia species, Mycobacterium tuberculosis, trichomonads, and Entamoeba histolytica. The main component of the essential oil is cineole, a monoterpene. Eucalyptus tincture exhibits antiseptic, anti-inflammatory, and disinfectant actions, which are due to the oxidizing effect of cineole and the anti-inflammatory influence associated with virtually all physiologically active substances present in its composition. The preparation also demonstrates a moderate sedative (calming) effect.

Pharmacokinetics.

Pharmacokinetics has not been determined.

Clinical characteristics.

Indications. Inflammatory diseases of the upper respiratory tract, nasopharynx, and oral cavity (tracheitis, laryngitis, pharyngitis, gingivitis, stomatitis), skin injuries (including infected wounds), as well as mild forms of neurotic disorders (irritability, emotional lability, sleep onset and sleep disturbances).

Contraindications. Bronchial asthma, bronchospasm. Inflammatory diseases of the gastrointestinal tract and biliary tract. Severe liver disease. Individual hypersensitivity to the drug.

Interaction with other medicinal products and other forms of interaction. Not established.

Special precautions.

Since the formulation contains ethanol, the tincture is not recommended for prolonged use.

Use during pregnancy or breastfeeding.

Since the formulation contains ethyl alcohol, the tincture is not recommended for oral use in women during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

When taking Eucalyptus tincture orally, caution should be exercised while driving or operating potentially hazardous machinery.

Administration and dosage.

Eucalyptus tincture is taken orally and can also be used for mouth rinsing and steam inhalations.

For adults, the recommended dose is 15–30 drops of the tincture 3–4 times daily after meals. For children aged 12 years and older, the dose is 1 drop per year of life, 3–4 times daily after meals.

For mouth rinsing, dilute 10–15 drops of the tincture in 200 ml of warm boiled water.

Steam inhalations should be performed using inhalers of any type, applying undiluted Eucalyptus tincture or diluted with water (as for mouth rinsing).

The duration of treatment depends on the therapeutic effect achieved and is determined by the physician.

Children.

Since the preparation contains ethanol, the tincture is not recommended for oral administration in children under 12 years of age.

Overdose. Not established.

Side effects.

Nausea, vomiting, and diarrhea. In cases of hypersensitivity to the drug, allergic reactions may occur (including urticaria, redness and skin rash, itching, Quincke's edema).

Shelf life. 5 years.

Storage conditions. Store in original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. Precipitation may occur during storage.

Packaging. 25 ml in glass bottles stoppered with corks or dropper caps and caps, or 50 ml in glass bottles stoppered with dropper caps and caps, in a carton or without a carton. 25 ml or 50 ml in polymer bottles stoppered with dropper caps and caps, in a carton or without a carton.

Availability category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and its business address.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.

Applicant. JSC Pharmaceutical Factory "Viola".

Applicant's address.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.