HEDUSSIN

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

Composition:

Active substance: dry extract of ivy leaves;

825 mg of dry extract of ivy leaves (Hedera helix L.) (4–8:1) in 100 ml of syrup; extraction solvent: ethanol 30% (m/m);

Excipients: non-crystallizing sorbitol solution, potassium sorbate, xanthan gum, anhydrous citric acid, purified water;

2 ml of syrup contain up to 0.938 g of the sugar substitute sorbitol.

Pharmaceutical form. Syrup.

Main physicochemical properties: brown, slightly cloudy liquid with a sweet taste. Sediment formation may occur during storage.

Pharmacotherapeutic group. Medicinal products used in cough and common cold. Expectorants. ATC code R05C A12.

Pharmacological properties.

Pharmacodynamics.

A plant-derived medicinal product containing dry ivy leaf extract, whose biologically active substances exert anti-inflammatory, spasmolytic, and secretolytic effects, promote bronchial dilation, and facilitate expectoration.

Pharmacokinetics.

There are no data available on the pharmacokinetics of the dry ivy leaf extract.

Clinical characteristics.

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

Contraindications. Hypersensitivity to the active substance, plants of the Araliaceae family, or to any other component of the medicinal product. Fructose intolerance.

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use.

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

If shortness of breath, fever, or purulent sputum occurs, immediate medical advice should be sought.

Concomitant use with antitussive agents, such as codeine or dextromethorphan, is not recommended without prior medical consultation.

Use with caution in patients with gastritis or peptic ulcer disease.

If the patient has known sugar intolerances, medical advice should be sought before taking this medicinal product.

Sorbitol contained in the medicinal product may have a mild laxative effect.

Use during pregnancy or breastfeeding.
Due to insufficient data, use of this medicinal product is not recommended during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery. Data are lacking.

Dosage and Administration.

Before each use, shake the syrup in the bottle well.

Oral use: Adults and children aged 12 years and older—6 mL of syrup twice daily; children aged 6–12 years—4 mL of syrup twice daily; children aged 2–6 years—2 mL of syrup twice daily.

The duration of treatment should be determined individually by a physician.

If symptoms do not resolve within 1 week of using the medication, or if any adverse reactions not listed in this instruction appear, discontinue use and consult a doctor.

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

Overdose.

Exceeding the recommended doses may cause nausea, vomiting, diarrhea, and agitation. Treatment is symptomatic.

Side effects

Allergic reactions such as dyspnea, Quincke's edema (angioedema), skin rash, urticaria, and itching may occur. Frequency is unknown.

Gastrointestinal disorders such as nausea, vomiting, diarrhea, and abdominal pain may occur in patients with increased sensitivity due to the sorbitol content.

If any adverse reactions not listed above occur, medical advice should be sought.

Reporting of suspected adverse reactions and lack of efficacy after marketing authorization is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and 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. 3 years.

After first opening of the bottle, the product can be used for up to 3 months.

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

Storage conditions. This medicinal product does not require special storage conditions.

Keep out of reach and sight of children.

After opening, store at a temperature not exceeding 25 °C.

Packaging. 100 ml in a bottle, 1 bottle with a measuring spoon in a cardboard box.

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

Manufacturer. Fitofarm Klenka S.A.

Manufacturer's address and place of business.
Klenka 1, 63-040 Nowe Miasto nad Wartą, Poland.