HEDERIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEDERIN (HEDERIN)

Composition:

Active substance: dry extract of ivy leaf;

1 ml of syrup contains 4.5 mg of dry extract of ivy leaf (Hederis folia) [(4–8):1] (extraction solvent – ethanol 30%) with a hederoside C content of 14%;

Excipients: sorbitol solution, non-crystallizing (E 420); xanthan gum; sodium carboxymethylcellulose; potassium sorbate; flavoring agent "Black Currant 522"; citric acid, monohydrate; purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: syrup-like liquid of light brown color with a characteristic odor and sweet taste. Opalescence and sediment formation may occur during storage.

Pharmacotherapeutic group.

Medicinal products used in cough and colds. Expectorants.

ATC code R05C A.

Pharmacological properties.

Pharmacodynamics.

A plant-derived medicinal product. The main biologically active substances in the dry extract of ivy leaves are saponin glycosides, which enhance secretion of the bronchial glands, exhibit secretolytic and expectorant effects, as well as general strengthening and tonic properties. Due to the presence of tannins, pectins, resins, and essential oil, the preparation exerts anti-inflammatory, antiseptic, and wound-healing actions.

Pharmacokinetics.

Not determined.

Clinical characteristics.

Indications.

Acute respiratory tract inflammatory diseases accompanied by cough; symptomatic treatment of chronic inflammatory bronchial diseases.

Contraindications.

Hypersensitivity to the components of the drug or to other plants of the Araliaceae family. Age under 2 years – due to the risk of worsening respiratory symptoms. Fructose intolerance.

Interaction with other medicinal products and other forms of interaction.

No undesirable effects have been observed when the drug is used concomitantly with other medicinal products. Therefore, the drug can be used with other medicinal agents, for example, antibiotics.

Special precautions for use.

Use in children aged 2–4 years requires medical advice. If symptoms persist for a prolonged period (more than 4–5 days) or if shortness of breath, fever, purulent sputum, or sputum with blood appear, immediate medical consultation is necessary. Concurrent use with antitussive agents, for example, codeine or dextromethorphan, is not recommended without prior medical consultation. Use with caution in patients with gastritis or gastric ulcer.

Sorbitol may cause mild laxative effect.

The product does not contain alcohol, sugar, or dyes.

Use during pregnancy or breastfeeding.

Due to insufficient data, the use of the product during pregnancy or breastfeeding is not recommended. Before administration, a physician must carefully weigh the risk-benefit ratio for these patient groups.

Ability to influence reaction rate when driving or operating machinery.

The product does not affect reaction speed when driving a vehicle or operating machinery.

Dosage and Administration.

Before each use, shake the bottle well.

For oral administration. For children aged 2 to 6 years: 2.5 mL of syrup three times daily; for children aged 6 to 10 years: 5 mL of syrup three times daily; for adults and children aged 10 years and older: 5–7.5 mL of syrup three times daily, using the dosing cup provided.

The syrup should be taken in the morning, during the day, and in the evening.

The duration of treatment is determined individually by a physician. In mild cases, treatment lasts up to 7 days. To achieve a sustained therapeutic effect, it is recommended to continue therapy for an additional 2–3 days after the patient's condition improves.

If there is no improvement in the patient's condition, consult a physician regarding further treatment.

Children.

The medication is contraindicated in children under 2 years of age due to the risk of worsening respiratory symptoms.

Overdose.

Ingestion of amounts exceeding the recommended three times daily dose may cause nausea, vomiting, diarrhea, and excitation.

Treatment is symptomatic.

Side effects.

Allergic reactions (mainly rash) may occur in patients with hypersensitivity, including dyspnea, mucosal edema, urticaria, pruritus, and telangiectasia; gastrointestinal disorders, including nausea, vomiting, diarrhea, and abdominal pain.

Shelf life. 5 years.

After first opening of the packaging, the product is suitable for use within 6 months.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

90 ml in a bottle or jar with a dosing cup in a carton.

Availability. Over-the-counter (without prescription).

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4, Korolyova St., Stanishivka, Zhytomyr district, Zhytomyr region, 12430, Ukraine.