Neuroplant^® (Tablets) Instructions for Use

Marketing Authorization Holder

Dr. Willmar Schwabe GmbH & Co. KG (Germany)

ATC Code

N06AX (Other antidepressants)

Active Substance

Hyperici herba (German DAB Pharmacopoeia)

Dosage Form

Neuroplant®

Film-coated tablets, 300 mg: 20, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets of brownish-yellow color, round, biconvex.

Extraction solvent methanol 80%.

Excipients: ascorbic acid – 6 mg, microcrystalline cellulose – 144 mg, corn starch – 40 mg, croscarmellose sodium – 30 mg, precipitated silicon dioxide – 5 mg, magnesium stearate – 5 mg.

Shell composition hypromellose (5 mPa·s) – 7 mg, hypromellose (15 mPa·s) – 7 mg, macrogol 4000 – 6 mg, lactose monohydrate – 4.92 mg, vanillin – 0.433 mg, sodium saccharin – 0.037 mg, yellow iron oxide (E172) – 1.8 mg, titanium dioxide (E171) – 3.6 mg, talc – 1.2 mg, antifoaming emulsion – 0.01 mg (simethicone – 9.2 mcg, methylcellulose (Eur.Ph.) – 0.77 mcg, sorbic acid – 0.03 mcg).

20 pcs. – blisters (1) – cardboard packs.
20 pcs. – blisters (2) – cardboard packs.
20 pcs. – blisters (3) – 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, isoquercitrin, 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 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

Oral: symptomatic and reactive depressions, anxiety, sleep disorders. As an additional agent for endogenous depressions (especially during menopause), 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

Take orally with a sufficient amount of liquid.

For adults and adolescents over 12 years: take one 300 mg film-coated tablet once daily.

Swallow the tablet whole; do not chew or crush.

Take the tablet at the same time each day, preferably in the morning with breakfast.

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

Continue treatment for the duration prescribed by your physician.

Do not exceed the recommended daily dose.

For symptoms persisting beyond 6 weeks, consult a physician for re-evaluation.

Discontinuation should be done under medical supervision; do not stop taking abruptly.

If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose; in that case, continue with the next scheduled dose. Do not take a double dose to make up for a forgotten tablet.

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 – 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 solarium, UV lamp, 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 enzyme system.

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, flushing, 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 30°C (86°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.