Negrustin^® (Solution) Instructions for Use

Marketing Authorization Holder

Hexal AG (Germany)

Manufactured By

Salutas Pharma, GmbH (Germany)

ATC Code

N06AX25 (Hyperici herba)

Active Substance

Hyperici herba (DAB German Pharmacopoeia)

Dosage Form

Negrustin®

Oral solution 791 mg/1 ml: bottle 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Oral solution clear, from brown to reddish-brown in color with an aromatic odor; during storage, the formation of a small sediment or cloudiness is possible.

Excipients: glycerol, propylene glycol, sorbitol 70%, flavorings.

50 ml – dark glass bottles (1) complete with a measuring cup – cardboard packs.
100 ml – dark glass bottles (1) complete with a measuring cup – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with antidepressant activity

Pharmacotherapeutic Group

Antidepressant of plant origin

Pharmacological Action

Herbal remedy. Contains anthracene derivatives – mainly hypericin, pseudohypericin; flavonoids – hyperoside, quercetin, rutin, isoquercytin, amentoflavone; xanthones – 1,3,6,7-tetrahydroxy-xanthone; acylphloroglucinols: hyperforin with small amounts of adhyperforin; essential oils; oligomers; procyanidins and other catechins tannins; caffeic acid derivatives, including chlorogenic acid.

It has a mild antidepressant, sedative and anxiolytic effect, as well as a stimulating effect on the gastrointestinal tract, circulation, and a general tonic effect.

It is believed that the antidepressant effect of the plant is due to the ability of its active substances to inhibit the reuptake of serotonin and other neurotransmitters, as well as the influence on melatonin metabolism.

Due to the high content of flavonoids, the plant has an anti-inflammatory effect. It has been established that hyperforin inhibits the growth of gram-positive bacteria Streptococcus pyogenes and Streptococcus agalactiae. The effectiveness of hyperforin against penicillin-resistant strains and methicillin-resistant strains of Staphylococcus aureus has been shown.

Indications

Orally: symptomatic and reactive depressions, anxiety states, sleep disorders. As an additional agent for endogenous depressions (especially during the climacteric period), as well as for diseases of the lungs, stomach, intestines, gallbladder; chronic colitis (as part of complex therapy).

Externally and locally: inflammatory diseases of the oral cavity (including gingivitis, stomatitis); as an additional agent for joint and muscle pain, as well as for hemorrhages and herpes zoster; for wound disinfection.

ICD codes

Dosage Regimen

Administer the oral solution using the provided measuring cup.

For adults and adolescents over 12 years, take 1 ml (approximately 20 drops) three times daily.

For depressive and anxiety disorders, the single dose may be increased to 2-3 ml three times daily as directed by a physician.

Take the solution with a sufficient amount of liquid.

For external use, apply the undiluted solution directly to the affected area several times daily for oral cavity inflammation or wound disinfection.

For use as a compress, apply a cloth soaked in the solution to the affected area for joint or muscle pain.

The full therapeutic effect for internal use typically develops after 2 to 4 weeks of continuous treatment.

Continue treatment for several months as medically advised to prevent relapse.

Do not exceed the recommended daily dose.

Discontinue use and consult a physician if symptoms worsen or photosensitivity reactions occur.

Adverse Reactions

Possible allergic reactions.

With prolonged use, unpleasant sensations in the liver area, a feeling of bitterness in the mouth are possible; in some cases, when taken orally – a photosensitizing effect (increased skin sensitivity to sunlight).

Contraindications

Hypersensitivity to the biologically active components of St. John’s wort, simultaneous use of MAO inhibitors; pregnancy, breastfeeding period; children under 12 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

It is assumed that St. John’s wort in high concentrations may damage reproductive cells.

During treatment, UV radiation should be avoided (including tanning beds, UV lamps, prolonged exposure to the sun).

Drug Interactions

With simultaneous use with MAO inhibitors, an increase in effects and the development of a hypertensive crisis are possible.

With simultaneous use, St. John’s wort can significantly affect the plasma concentration of any drugs metabolized with the participation of cytochrome P450 system enzymes.

With simultaneous use with digoxin, a decrease in the effectiveness of digoxin is possible, and after discontinuation of St. John’s wort preparations – an increase in the toxicity of digoxin.

With simultaneous use, tannic acids present in St. John’s wort can inhibit the absorption of iron.

There is a report of the development of acyclic bleeding with the simultaneous use of St. John’s wort with oral contraceptives containing a combination of ethinyl estradiol and levonorgestrel.

With simultaneous use, St. John’s wort reduces the plasma concentration of theophylline in patients regularly receiving theophylline.

With simultaneous use with fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, an increase in effects and the development of serotonin syndrome (increased sweating, tremor, redness, confusion, agitation) are possible.

With simultaneous use with cyclosporine, a decrease in the plasma concentration of cyclosporine is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.