INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOPHORAE JAPONICAE TINCTURE (SOPHORAE JAPONICAE TINCTURE)

Composition:

Active substance: Sophorae japonicae fruit tincture;

One vial contains 50 ml of Sophorae japonicae fruit tincture (Sophorae japonicae fructus) (1:2) (extractant – ethanol 48%);

Pharmaceutical form. Tincture.

Main physicochemical properties: clear brown liquid with a specific odor. Formation of a precipitate during storage is permissible.

Pharmacotherapeutic group.

Antiseptics and disinfectants. ATC code D08AX.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in the fruits of Sophora japonica (rutin, sophoroside, genistein, kaempferol, quercetin, and other substances) determine the anti-inflammatory, antimicrobial, and trophic effects of the medicinal product, strengthen vascular walls, and reduce their fragility.

Pharmacokinetics.

Not determined.

Clinical characteristics.

Indications.

Purulent inflammatory conditions (wounds, trophic ulcers).

Contraindications.

Individual hypersensitivity to the drug.

Interaction with other medicinal products and other forms of interaction.

Not known.

Special precautions.

Use during pregnancy or breastfeeding. Since ethanol is an ingredient of the medicinal product, the tincture is not recommended for use during pregnancy and breastfeeding.

Effect on the ability to drive or operate machinery. The medicinal product does not affect the ability to drive or operate machinery or to engage in other activities requiring high concentration of attention and rapid psychomotor reactions.

The medicinal product is a traditional herbal medicinal product intended for use according to indications supported by long-standing use.

Method of Administration and Dosage.

For topical use in adults and children aged 12 years and older in wound conditions – as applications under a dressing or as sprays.

The duration of treatment depends on the form and severity of the condition, the drug's efficacy, and the type of therapy (monotherapy or in combination with other medicinal products).

The patient should consult a physician if symptoms persist during treatment or if adverse reactions not listed in the medicinal product's instructions for medical use occur.

Children. Not recommended for use in children under 12 years of age.

Overdose.

Not established.

Side effects.

Allergic reactions (including redness, skin rash, itching).

Shelf life. 3 years.

Storage conditions.

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

Packaging.

50 ml in a bottle; 1 bottle per pack; 50 ml in bottles.

Prescription status. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of its business activities.

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