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Hawthorn (Tablets) Instructions for Use

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Herkel B.V. (Netherlands)

Dosage Form

Bottle OTC Icon Hawthorn Lozenges: 20 pcs.

Dosage Form, Packaging, and Product Composition

Lozenges weighing 1100 mg.

1 tab.
Dry extract of hawthorn 100 mg

Excipients: sorbitol, menthol, silicon dioxide, "honey" flavoring, aspartame, magnesium stearate.

10 pcs. – blisters (2) – cardboard packs.

Therapeutic Category

Dietary supplement – source of flavonoids and menthol

Properties

It has a moderate cardiotonic, spasmolytic and mild sedative effect, exhibits hypotensive properties, and normalizes blood coagulation parameters.

Scope of Application

Of the Hawthorn product

  • As part of complex therapy for functional disorders of cardiovascular activity (cardialgia, neurocirculatory dystonia).

Indications

  • Use as an adjunct in complex therapy for functional cardiovascular disorders.
  • Specifically indicated for managing symptoms such as cardialgia and in cases of neurocirculatory dystonia.

ICD codes

ICD-10 code Indication
F45.3 Somatoform dysfunction of the autonomic nervous system
R07.2 Pain in the heart region
ICD-11 code Indication
6C20.Z Bodily distress disorder, unspecified
MC86 Precordial pain

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Hold the lozenge in the mouth until it dissolves completely; do not chew or swallow whole.

Administer to adults at a dosage of 1 to 2 lozenges three times daily.

Continue the treatment course for 20 to 30 days. A repeat course is permissible only after consultation with a physician.

Adverse Reactions

Hypersensitivity reactions may occur, including urticaria and pruritus.

Administration of high doses can lead to drowsiness, arterial hypotension, arrhythmia, and, rarely, dizziness.

These adverse effects typically subside upon dose reduction or discontinuation of the product.

Drug Interactions

Concomitant use with cardiac glycosides (e.g., digoxin, strophanthin) may result in an additive cardiotonic effect.

Concurrent administration with beta-blockers can potentiate the hypotensive effect; monitor blood pressure closely.

Contraindications

  • Do not use in patients with a known hypersensitivity to any component of the product.
  • Contraindicated during pregnancy and lactation.
  • Not for use in individuals under 18 years of age.

Overdose

Symptoms of overdose are an extension of adverse reactions and may include severe hypotension, marked bradycardia, and profound sedation.

In case of suspected overdose, discontinue use immediately and institute supportive and symptomatic treatment; there is no specific antidote.

Use During Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Storage Conditions

The product should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

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.

Medical Disclaimer

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