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Instruction
For medical use of the medicinal product
Composition:
Active ingredient: 1 ml of the drug contains tincture of hellebore rhizomes with roots (veratri rhizomata cum radicibus) (1:10) [extractant ethanol 70% (v/v)] – 0.5 ml;
excipient: purified water.
Dosage form.
Solution for external use, water-alcohol.
Main physicochemical properties: cloudy brown-yellow liquid with sediment.
Pharmacotherapeutic group.
Drugs used in ectoparasitic diseases, including scabies. ATC code p03a x.
Pharmacological properties.
Pharmacodynamics.
A drug for the treatment of pediculosis. It has an antiparasitic effect (on lice and nits localized on the scalp and pubic area, as well as on clothing). Contains alkaloids as the main pharmacologically active compounds that are part of the roots and rhizomes of hellebore. The mechanism of action of the drug is due to the effect on the smooth muscles of the intestines of parasites, which disrupts their ability to feed and reproduce. In addition, the drug improves hair growth when applied externally, has a weak analgesic, antibacterial effect.
Pharmacokinetics.
When applied externally, the alkaloids that make up the preparation are practically not absorbed and do not have or have a slight resorptive effect. However, with prolonged use and active rubbing into the skin, they can partially penetrate very deep tissues and have resorptive effects.
Clinical characteristics.
Indication.
Pediculosis of the scalp and pubic area.
Contraindication.
Hypersensitivity to the components of the drug. Infected skin lesions.
Interaction with other drugs and other types of interactions.
With simultaneous use of preparations from plants containing tannins, the pharmacological effect is reduced.
Application features.
To avoid re-infection, it is necessary to disinfect underwear and bed linen simultaneously with the use of the drug.
The drug “Hellebore water” should be used only externally on intact skin. When using the drug, caution should be exercised and avoid contact with mucous membranes, eyes, or wound surfaces due to the risk of developing resorptive effects. It is necessary to remember the high toxicity of the drug when it enters the gastrointestinal tract and bloodstream. In case of contact with the mucous membrane of the eyes, rinse the eyes thoroughly with water.
Use during pregnancy or breastfeeding.
There is no data on the safety and effectiveness of the use of the medicinal product “Hellebore water” during pregnancy or breastfeeding, therefore the drug should not be prescribed during this period.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
Does not affect.
Method of administration and doses.
Before using the drug “Hellebore water” must be shaken. Apply the drug to thoroughly washed wet hair with a cotton or gauze swab. Then tie your head with a scarf, then wash your hands with soap. After 30 minutes, rinse your hair several times with warm running water, and then wash your hair with soap or shampoo. After washing, it is recommended to comb your hair with a thick comb to remove dead lice and nits. When using the drug, caution must be exercised.
Children.
The safety and effectiveness of the drug in children have not been established, therefore it is not recommended for use in children under 12 years of age without a doctor’s prescription.
Overdose.
With prolonged use and exceeding the recommended doses of the drug, the alkaloids that make up the drug can cause resorptive effects, which are manifested by hypotensive effects, nausea, vomiting, strong cholinomimetic effects and depression of cardiac activity. If a large amount of alkaloids enters the blood, cardiac arrest is possible, therefore taking the drug orally is unacceptable.
Treatment: symptomatic therapy; use of anticholinergics, cardiovascular drugs, and drugs to normalize the activity of the gastrointestinal tract.
First aid for poisoning.
In case of accidental ingestion of the drug – gastric lavage with tannin solutions, a suspension of activated charcoal or white clay; then prescribe saline laxatives; in case of damage to the mucous membranes – irrigation with a 2% solution of novocaine.
Adverse reactions.
Allergic reactions in the form of itching, erythema.
If the drug is accidentally ingested, nausea, vomiting, and allergic reactions are possible.
Expiration date.
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.
Package.
100 ml in a glass or polymer bottle. 1 bottle in a cardboard pack.
100 ml in a jar. 1 jar in a cardboard pack.
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