ECHINACEA PURPUREA RHIZOMES WITH ROOTS FRESH TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ECHINACEAE PURPUREAE RHIZOMATIS CUM RADICIBUS RECENTIUM TINCTURA (ECHINACEA PURPUREA FRESH ROOT AND RHIZOME TINCTURE)

Composition:

Active substance: 1 bottle contains: Echinacea purpurea fresh rhizome with root tincture (Echinaceae purpureae rhizomatis cum radicibus recentium) (1:5) (extraction solvent – ethanol 48%) – 40 ml;

Excipient: apart from the extraction solvent, none present.

Pharmaceutical form. Tincture.

Main physicochemical characteristics: transparent yellow-brown liquid with an aromatic odour and pungent taste. Formation of sediment during storage is permissible.

Pharmacotherapeutic group. Cytokines and immunomodulators.

ATC code L03A X.

Pharmacological properties.

Pharmacodynamics. The active ingredients of the medicinal product enhance phagocytic activity of neutrophils and macrophages, stimulate interleukin-1 synthesis, promote transformation of B-lymphocytes into plasma cells, and improve T-helper cell functions. Inulin, lavulose, and betaine improve metabolic processes, especially in the liver and kidneys. The medicinal product has antiviral, antibacterial, and antifungal properties.

Pharmacokinetics. Not determined.

Clinical characteristics.

Indications.

As part of complex treatment of immunodeficiency states in chronic recurrent inflammatory diseases of various localizations. Post-antibiotic therapy, cytostatic, immunosuppressive, or radiation therapy states. Early manifestations of acute respiratory viral infection (ARVI), during prolonged antibiotic use. Topically: treatment of slowly healing wounds.

Contraindications.

Hypersensitivity to Echinacea preparations, allergy to plants of the Asteraceae (Compositae) family, tuberculosis, leukemia, agranulocytosis, oncological diseases, rheumatism, connective tissue diseases (collagenoses), multiple sclerosis and other autoimmune diseases, AIDS, HIV infection, systemic lupus erythematosus, diabetes mellitus, primary immunosuppression, primary immunodeficiency of various etiologies, and other chronic viral diseases.

Pregnancy or breastfeeding period. Children under 12 years of age.

Interaction with other medicinal products and other types of interactions.

The medicinal product contains ethanol, which may enhance the absorption and pharmacological effect of certain sedative drugs and, indirectly, by altering the activity of the cytochrome P450 enzyme system, may affect the elimination of drugs metabolized by this system.

Ethanol may cause a disulfiram-like reaction when used concomitantly, for example, with certain antibacterial agents.

Due to the immunostimulatory effect of Echinacea, the medicinal product may reduce the effectiveness of immunosuppressive drugs.

The medicinal product is not recommended for simultaneous use with hepatotoxic agents such as amiodarone, methotrexate, ketoconazole, and steroid preparations.

Special precautions for use.

The duration of treatment with echinacea tincture should not exceed 8 weeks.

During storage, the tincture may become cloudy and a sediment may form, consisting of active polysaccharides. Therefore, the bottle should be shaken before use.

Use during pregnancy or breastfeeding.

The medicinal product is not to be used during pregnancy and breastfeeding due to its ethanol content.

Fertility – data not available.

Ability to affect reaction speed when driving or operating machinery.

The medicinal product contains ethanol, which should be taken into account by individuals who drive or operate complex machinery.

Method of Administration and Dosage.

To achieve a rapid effect in acute conditions at the beginning of treatment, adults should take 40 drops of the tincture, then after a 2-hour interval – another 20 drops. Subsequently, take 20 drops three times a day. The treatment course should not exceed 8 weeks.

For children aged 12 years and older, administer the tincture diluted 1:2 or 1:3, at a dose of 5–10 drops 2–3 times daily, 30 minutes before meals.

In wound treatment, apply the tincture locally to affected areas. Externally, use for compresses and tampons. Dilute 20–60 drops of the tincture in 100 mL of 0.9% sodium chloride solution, moisten gauze with this solution, apply it to the wound, and cover with compress paper. Change the dressing twice daily. The recommended duration of treatment with the drug is from 1 to 8 weeks.

Children.

The medicinal product should not be used in children under 12 years of age due to its ethanol content.

Overdose.

Symptoms: nausea, vomiting, gastrointestinal disturbances, sleep disorders, increased excitability, sleep disturbances.

Treatment: symptomatic therapy.

Adverse reactions.

Allergic reactions: skin redness, itching, rash, urticaria, Stevens−Johnson syndrome, angioneurotic edema, facial swelling, Quincke's edema, anaphylactic shock.

Respiratory system disorders: dyspnea, bronchospasm with obstruction, asthma.

Central nervous system disorders: dizziness.

Cardiovascular system disorders: arterial hypotension.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

There have been isolated reports of association with autoimmune diseases (disseminated encephalomyelitis, nodular erythema, immune thrombocytopenia, Evans' syndrome, Sjögren−Larsson syndrome with impaired renal tubular function).

With prolonged use (over 8 weeks), leukopenia may occur.

Shelf life.

3 years.

Storage conditions.

Store at temperature not exceeding 25 °C, in the original packaging, in a place inaccessible to children.

Packaging. 40 mL in bottles.

Availability category. Over-the-counter.

Manufacturer. LLC "DKP "Pharmaceutical Factory".

Manufacturer's location and address of business activity.

4 Korolyova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.