Herbion^® Hypericum (Tablets) Instructions for Use

Marketing Authorization Holder

Krka, D.D. (Slovenia)

ATC Code

N07XX (Other drugs for the treatment of nervous system diseases)

Active Substance

Hyperici herba (DAB German Pharmacopoeia)

Dosage Form

Herbion® Hypericum

Film-coated tablets, 300 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (3) – cardboard cartons.
10 pcs. – blister packs (6) – cardboard cartons.

Clinical-Pharmacological Group

Herbal preparation with antidepressant activity

Pharmacotherapeutic Group

Antidepressant of plant origin

Pharmacological Action

A herbal product. It contains anthracene derivatives – mainly hypericin, pseudohypericin; flavonoids – hyperoside, quercetin, rutin, isoquercetin, amentoflavone; xanthones – 1,3,6,7-tetrahydroxy-xanthone; acylphloroglucinols: hyperforin with small amounts of adhyperforin; essential oils; oligomers; procyanidins and other catechin 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 its 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 efficacy of hyperforin against penicillin-resistant strains and methicillin-resistant strains of Staphylococcus aureus has been demonstrated.

Indications

Oral: symptomatic and reactive depressions, anxiety, 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).

External and topical: 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

For oral administration of film-coated tablets. Swallow whole with a sufficient amount of liquid.

For adults and adolescents over 12 years: take one 300 mg tablettwo to three times daily.

Administer the daily dose in divided doses, typically with meals.

For sleep disorders, take the last daily dose in the evening.

The onset of therapeutic effect typically occurs after two to four weeks of continuous use.

Do not exceed the recommended daily dose of three tablets.

The total duration of use should be determined by a physician based on clinical response.

Discontinue use if symptoms of photosensitivity occur.

Consult a physician if no improvement is observed after six weeks of treatment.

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

When used concomitantly with MAO inhibitors, an enhancement of effects and the development of a hypertensive crisis are possible.

When used concomitantly, St. John’s wort can significantly affect the plasma concentration of any drugs metabolized with the participation of cytochrome P450 system enzymes.

When used concomitantly 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.

When used concomitantly, tannic acids present in St. John’s wort may inhibit the absorption of iron.

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

When used concomitantly, St. John’s wort reduces the plasma concentration of theophylline in patients regularly receiving theophylline.

When used concomitantly with fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, an enhancement of effects and the development of serotonin syndrome (increased sweating, tremor, redness, confusion, agitation) are possible.

When used concomitantly 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.