Helarium^® Hypericum (Dragee) Instructions for Use

Marketing Authorization Holder

Bionorica, SE (Germany)

ATC Code

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

Active Substance

Hyperici herba (DAB German Pharmacopoeia)

Dosage Form

Helarium® Hypericum

Dragees: 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Dragee greenish-yellow in color, round, biconvex.

Excipients: highly dispersed silicon dioxide, potato starch, lactose, magnesium stearate.

Shell composition: shellac, talc, calcium carbonate, titanium dioxide (E171), sucrose, kaolin, macrogol, gum arabic, quinoline yellow (E104), green lake-forming agent (E104/E132).

15 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with antidepressant activity

Pharmacotherapeutic Group

Antidepressant of plant origin

Pharmacological Action

Herbal preparation. It has an antidepressant and anxiolytic effect (relieves anxiety, tension, improves mood).

Pharmacokinetics

Data on the pharmacokinetics of the drug Helarium^® Hypericum are not provided.

Indications

• Psychovegetative disorders (low mood, apathy);
• Mild to moderate depressive states;
• Neurotic reactions.

ICD codes

Dosage Regimen

Administer 1 dragee three times daily to adults and children over 12 years of age.

Take the dragees with meals, swallowed whole without chewing, and with a sufficient amount of water.

Continue treatment for a minimum of 4 weeks to achieve the full therapeutic effect.

Consult a physician if symptoms persist beyond 4 weeks of continuous use.

Avoid concurrent use with MAO inhibitor antidepressants; maintain a washout period of at least 14 days between therapies.

Be aware of potential drug interactions; this product may reduce the efficacy of oral contraceptives, anticoagulants, cyclosporine, and certain antivirals.

Due to the risk of photosensitization, avoid excessive sun exposure and UV radiation during treatment, particularly for fair-skinned individuals.

Each dose contains less than 0.03 XE; consider this for patients with diabetes mellitus.

Adverse Reactions

Dermatological reactions photosensitization (especially in persons with fair skin).

Other rarely – allergic skin reactions, dyspepsia, fatigue, restlessness.

Contraindications

• Simultaneous treatment with cyclosporine, indinavir and other protease inhibitors in HIV-positive patients;
• Children under 12 years of age;
• Established photosensitivity of the skin to ultraviolet radiation;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Helarium^® Hypericum should not be prescribed during pregnancy and lactation (breastfeeding) due to the lack of sufficient experience with the use of the drug during these periods.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

The drug should not be taken simultaneously with antidepressants – MAO inhibitors. The interval between taking these drugs should be at least 14 days.

When prescribing the drug to patients with diabetes mellitus, it should be taken into account that 1 single dose of the drug contains less than 0.03 XE.

Effect on the ability to drive vehicles and machinery

The drug does not affect the ability to drive a car and work with machinery.

Overdose

Cases of acute poisoning with the drug have not been known to date. In case of significant overdose, patients should avoid exposure to the sun and UV radiation for 1-2 weeks.

Drug Interactions

When Helarium Hypericum is used concomitantly with coumarin-type anticoagulants (phenprocoumon, warfarin), cyclosporine, theophylline, indinavir, digoxin, amitriptyline, nortriptyline, methadone, verapamil, a decrease in their effectiveness is possible.

When Helarium Hypericum is used concomitantly with nefazodone, paroxetine, sertraline, an enhancement of their action is possible.

When Helarium Hypericum is used concomitantly with oral hormonal contraceptives, a weakening of their action is possible.

The drug enhances the photosensitizing effect of tetracyclines, sulfonamides, thiazide diuretics, quinolones, piroxicam.

Storage Conditions

The drug should be stored in a dry place, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.