Sophora japonica tincture

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOFORA JAPANESE TINCTURE

Composition:
Active substance: crushed fruit tincture of Japanese sophora (Fructus Sophorae japonicae);
1 bottle contains 40 ml of crushed fruit tincture of Japanese sophora (Fructus Sophorae japonicae) (1 : 2) (extractant – ethanol 48%).

Medicinal form. Tincture.

Main physicochemical properties: Transparent brown liquid with a characteristic odor. Sediment may occur during storage.

Pharmacotherapeutic group. Antiseptics and disinfectants.
ATC code: D08AX.

Pharmacological properties. Biologically active substances contained in the fruits of Japanese sophora (rutin, sophoroside, genistein, kaempferol, quercetin, and other compounds) determine the anti-inflammatory, antimicrobial, and trophic effects of the preparation, strengthen blood vessel walls, and reduce their fragility.

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. Unknown.

Special precautions for use.

Use during pregnancy or breastfeeding. Since the preparation contains ethanol, it is not recommended for use in pregnant women and women during breastfeeding.

Ability to influence reaction rate when driving vehicles or operating machinery. The drug does not affect the ability to drive vehicles or engage in other activities requiring increased attention and psychomotor reaction speed.

Method and dosage of administration. 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 disease, the effectiveness of the drug, and the type of therapy (monotherapy or combination therapy with other medicinal products).

Children. Not to be used in children under 12 years of age.

Overdose. Not established.

Adverse 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. 40 ml in bottles.

Release category. Over-the-counter.

Manufacturer. JSC "FITOFARM".
Location and address of manufacturer’s place of business:
2 Sybirtseva St., Bakhmut, Donetsk region, 84500, Ukraine.

Marketing authorization holder. JSC "FITOFARM".
Address of the marketing authorization holder:
12 Almatinska St., Kyiv, 02092, Ukraine.