EUCAFILIPT®

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

Composition:

Active substance: Eucalyptus leaf tincture (1:10) (extractant – 96% ethanol); 1 ml of the preparation contains 1 ml of Eucalyptus leaf tincture (1:10) (extractant – 96% ethanol), calculated as cineole – not less than 0.2 mg;

Excipient: zinc chloride.

Pharmaceutical form. Tincture.

Main physicochemical properties: liquid, ranging in color from green to dark green. Sediment formation may occur during storage.

Pharmacotherapeutic group. Medicinal products used in throat diseases. Antiseptics. ATC code R02AA20.

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 coli, Mycobacterium tuberculosis, Trichomonas, 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 oxidative effect of the monocyclic terpene cineole and anti-inflammatory influence associated with virtually all physiologically active substances contained in its composition. The medicinal product also has a moderate sedative (calming) effect.

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), as well as mild forms of neurotic disorders (irritability, emotional lability, difficulty falling asleep and sleep disturbances).

Contraindications.

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

Interaction with other medicinal products and other forms of interactions.

Not established.

Special precautions for use.

The medicinal product contains ethanol in an amount of not less than 88.0% (v/v).

Use during pregnancy or breastfeeding.

Since ethanol is an ingredient of the tincture, it is not recommended for oral use in women during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

When taking the tincture orally, avoid driving vehicles or operating potentially hazardous machinery.

Dosage and Administration.

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

Shake well before use.

Adults are recommended to take 15–30 drops of the tincture (1 teaspoon) orally, previously diluted in ¼ cup of boiled water, 3–4 times daily after meals. For children aged 12 years and older, the dosage is calculated as 1 drop per year of life, 3–4 times daily after meals.

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

For steam inhalations, use the tincture undiluted or diluted with water (as for rinsing) with inhalers of any type.

The duration of treatment depends on the therapeutic effect achieved, as determined by the physician.

Children.

Since ethanol is an ingredient of the tincture, oral administration is not recommended for children under 12 years of age.

Overdose.

Not established.

Adverse reactions.

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 drug should be discontinued.

Shelf life. 2 years.

Storage conditions.

Store in a place inaccessible to children.

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

Sedimentation may occur during storage.

Do not use after the expiry date.

Packaging.

100 ml in bottles No. 1 in a pack.

100 ml in jars No. 1 in a pack.

Dispensing category. Over-the-counter.

Manufacturer.

PJSC "CHIMFARMPRODUCT 'CHERVONA ZIRKA'".

Manufacturer's location and address of business activity.

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