SOPHORA JAPONICA TINCTURE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOFORA JAPONICA TINCTURE (TINCTURA SOPHORAE JAPONICAE)

Composition:

Active substance: Sophora japonica fruit tincture (Fructus Sophorae japonicae) (1:2) (extraction solvent – 48% ethanol);

1 vial contains Sophora japonica fruit tincture (Fructus Sophorae japonicae) (1:2) (extraction solvent – 48% ethanol) 20 ml or 25 ml, or 40 ml.

Pharmaceutical form. Tincture.

Main physicochemical properties: clear brown liquid. Formation of a precipitate is permissible.

Pharmacotherapeutic group.

Antiseptics and disinfectants. ATC code D08AX.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in the fruits of Japanese sophora (rutin, sophoroside, genistein, kaempferol, quercetin, and other substances) provide the drug's anti-inflammatory, antimicrobial, and trophic effects, strengthen blood vessel walls, and reduce their fragility.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Purulent inflammatory processes (wounds, trophic ulcers).

Contraindications.

Individual hypersensitivity to the drug.

Interaction with other medicinal products and other types of interactions.

Not known so far.

Special precautions.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction speed when driving or operating machinery.

The medicinal product does not affect the ability to drive or operate machinery and to perform other tasks requiring increased attention and rapid psychomotor reactions.

Method of Administration and Dosage.

For external 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, effectiveness of the drug, and the type of therapy (monotherapy or combination therapy with other medicinal products).

Children.

Not recommended for children under 12 years of age.

Overdose.

Not established.

Side effects.

Allergic reactions, including redness, skin rash, itching.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

20 ml, 25 ml, or 40 ml in bottles sealed with a stopper and cap or dropper stopper and cap. 20 ml or 25 ml in a bottle sealed with a dropper stopper and cap, in a carton. 40 ml in a bottle sealed with a stopper and cap or dropper stopper and cap, in a carton.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.