Zhivokost

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ZHYVOKOST (SYMPHYTUM)

Composition:

Active ingredients: 100 g of ointment contains Symphytum root tincture (Symphyti radices) (1:5) (extractant — 65% ethanol) — 10 g, tocopherol acetate (vitamin E) — 1 g;

Excipients: white soft paraffin, refined corn oil, glycerin, Span 80, pine essential oil, methylparahydroxybenzoate (E 218), purified water.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: ointment ranging from creamy to light brown in color with a characteristic odor.

Pharmacotherapeutic group. Medicinal products used locally for joint and muscular pain. ATC code M02AX10.

Pharmacological properties.

Pharmacodynamics.

The effect of the medicinal product is determined by its constituent components. The main active substances in comfrey root are allantoin, mucilage, and tannins. These provide anti-inflammatory and analgesic effects and promote bone callus formation. Allantoin regenerates the epithelium and reduces pain.

Vitamin E enhances the effect of allantoin, improves cellular nutrition, and protects cells from destruction.

Pharmacokinetics. Pharmacokinetic studies have not been conducted.

Clinical characteristics.

Indications.

Joint, back, and lumbar pain associated with radiculitis, osteochondrosis, and arthritis. Sports- and household-related injuries such as contusions, tendon strains, and closed bone fractures. Dry and cracked skin.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Not known.

If simultaneous use of any other medicinal products is required, consult a physician.

Special precautions for use.

To avoid the occurrence of adverse effects, a small amount of the ointment should be applied in advance to the skin to determine individual sensitivity.

Do not apply to skin areas with signs of allergic reaction, mucous membranes (including the nasal mucosa), or the area around the eyes, or to open wounds. Do not apply the drug to facial areas; avoid contact of the ointment with the eyes. Apply exclusively to intact skin.

If symptoms persist or worsen during use of the medicinal product, consult a physician.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated in women during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery. Unknown.

Method of Administration and Dosage.

For adults, apply a thick layer of the ointment to affected areas 2–3 times daily. At night, apply a thick layer of the ointment and cover with a dressing.

The duration of treatment depends on the nature and course of the disease, but generally should not exceed 4–6 weeks per year.

Children.

The use of the medicinal product in children and adolescents under 18 years of age is contraindicated.

Overdose.

Overdose may enhance the manifestations of adverse reactions. If allergic symptoms occur, discontinue the drug and wash off any residue from the skin. Symptomatic therapy should be administered.

No cases of overdose have been reported to date.

Adverse reactions.

Hypersensitivity reactions to components of the medicinal product are possible (including itching, swelling, urticaria).

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging. 50 g or 100 g in a jar in a carton; 40 g or 100 g in a tube in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's name and address of the place of business.

75 Amosova Avenue, Zaporizhzhia, 69063, Ukraine.