Eucalypta tincture

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EUKALIPTA TINCTURE

Composition:

Active ingredient: 1 vial contains eucalyptus leaf tincture (Eucalyptifolium) (1 : 5) (extraction solvent – ethanol 70%) – 25 ml;

Excipients: apart from the extraction solvent, none.

Pharmaceutical form. Tincture.

Main physicochemical properties: clear greenish-brown liquid with a specific odor. During storage, formation of a sediment is possible.

Pharmacotherapeutic group.
Agents for local use in dentistry. ATC Code A01AD11.

Pharmacological properties.

Pharmacodynamics. "Eucalyptus 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 detrimental effects on fungi and protozoa. Eucalyptus inhibits the growth of Staphylococcus aureus, Escherichia, Mycobacterium tuberculosis, trichomonads, and Entamoeba histolytica. The main component of the essential oil is cineole (a monocyclic terpene). "Eucalyptus tincture" has antiseptic, anti-inflammatory, and disinfectant actions, caused by the oxidative effect of the monocyclic terpene cineole and anti-inflammatory influence associated with practically all physiologically active substances contained in its composition. The preparation also exhibits a moderate sedative (calming) effect.

Pharmacokinetics. Not studied.

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.

Hypersensitivity to components of the medicinal product. Bronchial asthma, bronchospasm. Inflammatory diseases of the gastrointestinal tract and biliary tract. Severe liver disease.

Interaction with other medicinal products and other types of interactions.

Unknown.

Special precautions.

Since the preparation contains ethanol, prolonged use of the tincture is not recommended.

"Eucalyptus tincture" is a traditional herbal medicinal product for use according to indications supported by long-standing use.

Use during pregnancy or breastfeeding.

Since the medicinal product contains ethanol, the tincture is not recommended for internal use in women during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Patients should refrain from driving or operating potentially hazardous machinery during internal use of the preparation.

Dosage and Administration

"Eucalyptus Tincture" is intended for oral use, as well as for mouth rinsing and steam inhalations.

Adults are recommended to take 15–30 drops orally 3–4 times daily after meals. For children aged 12 years and older: 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).

Duration of treatment depends on the therapeutic effect achieved and is determined individually by a physician.

The patient should consult a physician if symptoms of the disease do not resolve during treatment or if any adverse reactions occur.

Children

Do not administer orally to children under 12 years of age due to ethanol content.

Overdose

Not established.

Adverse reactions.

Immune system reactions: allergic reactions (including urticaria, redness and skin rash, itching, angioedema) may occur in case of hypersensitivity to the drug; sometimes contact dermatitis (in the lip area).

Gastrointestinal disorders: nausea, vomiting, and diarrhea.

If pronounced reactions occur, the use of the drug should be discontinued.

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging.

25 ml in dropper bottles (without carton or in a carton).

Availability category. Over-the-counter.

Manufacturer/Applicant.

LLC "Ternopharm".

Manufacturer's address and location of business activity/applicant's address.

LLC "Ternopharm".

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua