Hederal® ivy
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEDERAL® IVY (HEDERAL® HEDERA HELIX)
Composition:
Active ingredient: dried extract of common ivy leaf;
1 ml of syrup contains 7 mg of dried extract of common ivy leaf (Hederae helicis e folium)
(4–8:1), extraction solvent: ethanol 30%;
Excipients: potassium sorbate (E 202); citric acid monohydrate (E 330); xanthan gum (E 415); lemon flavor; sorbitol liquid, non-crystallizing (E 420); purified water.
2.5 ml of syrup contain 0.963 g of sugar-substitute sorbitol = 0.080 bread unit.
Pharmaceutical form. Syrup.
Main physicochemical properties: yellow-brown syrup with a characteristic lemon odor. The presence of sediment is permissible.
Pharmacotherapeutic group. Preparations used for cough and colds. Expectorants.
ATC code R05C A12.
Pharmacological properties.
The drug is of plant origin and contains glycosidic saponins, which provide expectorant, spasmolytic, bronchodilatory, anti-inflammatory, and antimicrobial effects. The main components of the dry extract of ivy leaves are triterpene saponins, primarily hederacoside C and alpha-hederin.
Alpha-hederin inhibits endocytosis of β2-adrenergic receptors, thereby increasing β2-adrenergic cell activity in the bronchial mucosa and lung epithelium. This leads to a reduction in intracellular calcium levels in the bronchial mucosa, resulting in bronchial relaxation. By stimulating β2-adrenergic receptors, alveolar epithelial cells of type II produce more surfactant. Thus, HEDERAL® IVY reduces sputum viscosity, facilitates expectoration, and relieves cough.
Clinical characteristics.
Indications.
Acute respiratory tract inflammatory diseases accompanied by cough; symptomatic treatment of chronic inflammatory bronchial diseases.
Contraindications.
Hypersensitivity to any component of the medicinal product or to other plants of the Araliaceae family. Children under 2 years of age (due to the risk of worsening respiratory symptoms when taking secretolytic agents).
Interaction with other medicinal products and other forms of interaction.
No adverse effects have been observed when HEDERAL® IVY was used concomitantly with other drugs. Therefore, HEDERAL® IVY can be used together with other medicinal products, such as antibiotics.
Concomitant use with antitussive agents, such as codeine or dextromethorphan, is not recommended without medical consultation.
Special precautions for use
Persistent or recurrent cough in children aged 2 to 4 years requires medical diagnosis before starting treatment.
If shortness of breath, fever, or purulent sputum occurs, consult a physician.
Use with caution in patients with gastritis or peptic ulcer.
The medicinal product does not contain alcohol, sugar, or dyes.
Important information about excipients.
This medicinal product contains potassium compounds. Caution is advised when administering to patients with impaired renal function or those on a low-potassium diet.
If intolerance to certain sugars has been diagnosed, consult a physician before taking this 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.
No studies on the effect on the ability to drive vehicles or operate machinery have been conducted.
Method of administration and dosage.
HEDERAL® IVY syrup should be taken in the morning, during the day, and in the evening, regardless of food intake.
| Age group |
Dosage |
| Adults and children from 10 years |
5–7.5 ml three times a day |
| Children aged 6 to 10 years |
5 ml three times a day |
| Children aged 2 to 6 years |
2.5 ml three times a day |
The dose should be measured using the dosing cup provided.
The duration of treatment is determined individually by the physician. In mild cases, the treatment duration is 1 week. To achieve a sustained therapeutic effect, it is recommended to continue therapy for another 2–3 days after the patient's condition improves.
The contents of the bottle must be shaken well before use!
If the patient's condition does not improve, consult a physician for further treatment.
Children.
The medicinal product is contraindicated in children under 2 years of age due to the risk of worsening respiratory symptoms.
Use in children aged 2–4 years requires a physician's recommendation.
Overdose.
Symptoms: overdose may cause nausea, vomiting, diarrhea, feelings of anxiety, and excitement.
Treatment: symptomatic.
Adverse reactions.
Allergic reactions are possible (mainly rash, itching, urticaria, angioedema, anaphylactic reactions), couperosis, dyspnea, as well as gastrointestinal disorders (including nausea, vomiting, diarrhea, abdominal pain).
If adverse reactions occur, treatment should be discontinued and medical advice sought.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions after marketing authorization is an important procedure. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national pharmacovigilance system.
Shelf life. 3 years.
After opening the bottle, the medicinal product can be used for up to 3 months.
Do not use the medicinal product 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. 115 ml or 200 ml of syrup in a bottle; 1 bottle with a measuring cup in a box.
Availability. Over-the-counter.
Manufacturer.
JSC "VITAMINS".
Manufacturer's address.
31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.