Veratrum water

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VERATRI AQUA (VERATRI AQUA)

Composition:

Active substance: 1 ml of the preparation contains an extract of hellebore rhizomes with roots (Veratri rhizomata cum radicibus) (1:10) [extractant ethanol 70% (v/v)] – 0.5 ml;

Excipient: purified water.

Pharmaceutical form. Solution for external use, aqueous alcoholic.

Main physicochemical characteristics: turbid brownish-yellow liquid with sediment.

Pharmacotherapeutic group.

Agents used in ectoparasitosis, including scabies.

ATC code P03AX.

Pharmacological properties.

Pharmacodynamics.

A drug for the treatment of pediculosis. Exerts antiparasitic action (against lice and nits located on hairy areas of the head and pubis, as well as on clothing). Contains alkaloids as the main pharmacologically active compounds derived from the roots and rhizomes of Veratrum album. The mechanism of action is due to its effect on the smooth musculature of the parasite's intestine, disrupting its ability to feed and reproduce. In addition, when applied topically, the drug improves hair growth and exerts weak analgesic and antibacterial effects.

Pharmacokinetics.

When applied topically, the alkaloids contained in the drug are practically not absorbed and produce no or only negligible systemic effects. However, with prolonged use and vigorous rubbing into the skin, they may partially penetrate into deeper tissues and produce systemic effects.

Clinical characteristics.

Indications.

Pediculosis of the scalp and pubic area.

Contraindications.

Hypersensitivity to the components of the medicinal product. Infected skin lesions.

Interaction with other medicinal products and other types of interactions.

When used simultaneously with drugs derived from plants containing tannins, the pharmacological effect is reduced.

Special precautions.

To avoid re-infection, it is necessary to disinfect underwear and bed linen simultaneously with the use of the medicinal product.

The medicinal product "Veratrum water" must be used externally only on intact skin. When using the medicinal product, caution should be exercised to prevent its contact with mucous membranes, eyes, or wound surfaces due to the risk of developing resorptive effects. One must remember the high toxicity of the product if it enters the gastrointestinal tract or bloodstream. In case of contact with the mucous membrane of the eyes, rinse eyes thoroughly with water.

"Veratrum water" is a traditional medicinal product used according to indications supported by long-term use.

Use during pregnancy or breastfeeding.

There are no data available on the safety and efficacy of the medicinal product "Veratrum water" during pregnancy or breastfeeding; therefore, the product should not be used during these periods.

Ability to affect the reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

Before using the drug "Centaury Water", shake it well. Apply the preparation to thoroughly washed wet hair using a cotton or gauze swab. Then cover the head with a scarf and immediately wash hands with soap. After 30 minutes, rinse the hair several times with warm running water, then wash the hair with soap or shampoo. After washing, it is recommended to comb the hair with a fine-toothed comb to remove dead lice and nits. Exercise caution during application of the preparation.

The patient should consult a physician if symptoms of the disease do not disappear during treatment with the medicinal product or if adverse reactions occur that are not listed in the instructions for medical use.

Children.

The safety and efficacy of the drug in children have not been established; therefore, it is not recommended for use in children under 12 years of age without physician's prescription.

Overdose.

With prolonged use and exceeding the recommended doses, alkaloids contained in the drug may cause systemic (resorptive) effects manifested by hypotensive action, nausea, vomiting, strong cholinomimetic action, and suppression of cardiac activity. In case of a large amount of alkaloids entering the bloodstream, cardiac arrest is possible; therefore, oral intake of the preparation is strictly contraindicated.

Treatment: symptomatic therapy; use of anticholinergic agents, cardiovascular drugs, and agents to normalize gastrointestinal tract function.

First Aid in Poisoning.

In case of accidental ingestion of the drug—perform gastric lavage with tannin solutions, suspension of activated charcoal, or kaolin; then administer saline laxatives. In case of mucous membrane damage—irrigate with 2% novocaine solution.

Side effects.

Allergic reactions in the form of skin itching, erythema.

If the product is accidentally ingested, nausea, vomiting, and allergic reactions are possible.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging.

100 ml in a glass or polymer bottle. 1 bottle per cardboard box.

100 ml in a jar. 1 jar per cardboard box.

Prescription status. Prescription only.

Manufacturer.

JSC “CHEMICAL PHARMACEUTICAL PLANT “CHERVONA ZIRKA”

Manufacturer's location and address of business activity.

1, Hordiienkivska Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine