Herbion® ivy syrup

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HERBION® IVY SYRUP (Herbion® ivy syrup)

Composition:

Active substance: dry extract of ivy leaves;

1 ml of syrup contains 7 mg of dry extract of ivy leaves (5–7.5):1 (Hedera helix L., folium extractum siccum) containing not less than 0.6 mg of hederacoside C;

Extraction solvent: ethanol 30% (m/m);

Excipients: sorbitol solution, non-crystallizing (E 420); glycerin; sodium benzoate (E 211); citric acid monohydrate; aromatic balsam consisting of propylene glycol, ethanol 96%, citronella oil, citral, extract of exotic verbena, lemon oil, and coriander oil; purified water.

Medicinal form. Syrup.

Main physicochemical properties: yellow-brown syrup with a characteristic odor and taste. A slight sediment may be present, which is typical for natural substances.

Pharmacotherapeutic group. Medicinal products used in cough and common cold conditions. Expectorants, excluding combined preparations containing antitussives. Expectorant agents. ATC code R05CA12.

Pharmacological properties.

Pharmacodynamics.

Herbion® ivy syrup contains a dry extract of ivy leaves, which acts as a mucolytic, spasmolytic, and broncholytic agent. The main components of the dry extract of ivy leaves are triterpene saponins, primarily hederacoside C and alpha-hederin. The mechanism of action is unknown.

Pharmacokinetics.

There are no available data on the pharmacokinetic properties of the dry extract of ivy leaves.

Clinical characteristics.

Indications.

• Acute respiratory tract inflammatory diseases accompanied by cough;
• symptomatic treatment of chronic inflammatory diseases of the bronchi.

Contraindications.

Hypersensitivity to the active substance or to other plants of the Araliaceae family, or to any other component of the medicinal product; children under 2 years of age — due to the general risk of worsening respiratory symptoms associated with the use of secretolytic agents.

Interaction with other medicinal products and other types of interactions.

To date, interactions are unknown. No interaction studies have been conducted.

Special precautions for use

Concurrent use with antitussive agents (e.g., codeine or dextromethorphan) is not recommended without prior medical consultation. Use with caution in patients with gastritis or peptic ulcer. If dyspnea, fever, or purulent sputum occurs, consult a physician regarding further use of the medicinal product.

Children

Herbion® Ivy Syrup is contraindicated in children under 2 years of age (see section "Contraindications").

Persistent or recurrent cough in children aged 2 to 4 years requires medical diagnosis before treatment.

Sorbitol (E 420)

The medicinal product contains sorbitol. The additive effect should be taken into account when consuming products containing sorbitol (or fructose) simultaneously, as well as when sorbitol (or fructose) is ingested with food. Sorbitol may affect the bioavailability of other medicinal products taken concomitantly.

Patients with rare hereditary fructose intolerance should not take this medicinal product.

Sorbitol (≥ 140 mg/kg/day) may cause gastrointestinal discomfort and a slight laxative effect.

When used according to instructions, the patient will receive:

up to 0.875 g of sorbitol per 2.5 mL dose of syrup, equivalent to 0.073 bread units;

up to 1.750 g of sorbitol per 5 mL dose of syrup, equivalent to 0.146 bread units;

up to 2.625 g of sorbitol per 7.5 mL dose of syrup, equivalent to 0.219 bread units.

Ethanol

The medicinal product contains methanol: 5 mL of syrup (1 measuring spoon) contains 0.5 mg of ethanol. The amount of ethanol in the maximum dose of 15 mL of this product is equivalent to less than 0.0375 mL of beer or 0.015 mL of wine. This amount of ethanol will not have a noticeable effect.

Sodium (contained in sodium benzoate)

Herbion® Ivy Syrup contains less than 1 mmol of sodium (23 mg) per 5 mL, i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding

The use of this medicinal product during pregnancy or breastfeeding is not recommended due to insufficient data. Information regarding fertility is lacking.

Ability to influence reaction speed when driving or operating machinery

No studies on the effect of Herbion® Ivy Syrup on the ability to drive or operate machinery have been conducted.

Method of Administration and Dosage

Adults and children aged 12 years and older: 5 ml of syrup three times daily (corresponding to 105 mg of dry ivy leaf extract per day).

Children aged 6 to 11 years: 5 ml of syrup twice daily (corresponding to 70 mg of dry ivy leaf extract per day).

Children aged 2 to 5 years: 2.5 ml of syrup three times daily (corresponding to 52.5 mg of dry ivy leaf extract per day).

The syrup should be administered using the measuring spoon provided, with graduations at 2.5 ml intervals. The measuring spoon holds 5 ml of syrup; half a spoon (½ spoon) contains 2.5 ml of syrup.

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

Do not exceed the recommended daily dose.

During treatment with Herbion® Ivy Syrup, it is recommended to drink plenty of tea or other warm beverages.

The medication may be taken independently of food intake.

Duration of treatment depends on the nature and severity of the illness. Treatment usually lasts 7 days. If symptoms persist beyond one week during treatment, consult a physician.

Children.

This medicinal product is contraindicated in children under 2 years of age (see section "Contraindications").

Overdose.

Overdose may cause nausea, vomiting, diarrhea, and agitation.

Do not take doses exceeding those recommended. In case of overdose, seek immediate medical advice. Treatment is symptomatic. One case of overdose has been reported in a 4-year-old child who developed aggression and diarrhea after accidental ingestion of ivy extract amounting to 1.8 g of plant substance (equivalent to approximately 7–10 measuring spoons of Herbion® Ivy Syrup).

Side effects.

Gastrointestinal disorders: gastrointestinal disturbances (including nausea, vomiting, diarrhea) — frequency unknown.

Immune system disorders: allergic reactions (urticaria, skin rash, flushing, dyspnea, anaphylactic reactions) — frequency unknown.

If severe adverse effects occur, treatment should be discontinued.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after medicinal product registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 2 years.

After opening the bottle, the syrup may be used for up to 3 months.

Storage conditions.

No special storage conditions are required for this medicinal product. Do not refrigerate.

Keep out of reach of children.

Packaging.

150 ml of syrup in a brown glass bottle; 1 bottle with a plastic measuring spoon in a cardboard box.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

KRKA, d.d., Novo mesto / KRKA, d.d., Novo mesto.

Manufacturer's address and place of business.

Smarjeska cesta 6, 8501 Novo mesto, Slovenia / Smarjeska cesta 6, 8501 Novo mesto, Slovenia.