Instructions Herbion syrup Ivy syrup 7 mg/ml bottle 150 ml
Composition
active ingredient: dry ivy leaf extract;
1 ml of syrup contains 7 mg of dry ivy leaf extract (5-7.5): 1 (Hedera helix L., folium extractum siccum) containing at least 0.6 mg of hederacoside C;
extractant: ethanol 30% (w/w);
excipients: sorbitol non-crystallizing solution (E 420); glycerin; sodium benzoate (E 211); citric acid monohydrate; aromatic balm consisting of propylene glycol, ethanol 96%, citronella oil, citral extract of exotic verbena, lemon oil and coriander oil; purified water.
Dosage form
Syrup.
Main physicochemical properties: yellow-brown syrup with a specific odor and taste. A slight precipitate, typical of natural substances, may be present.
Pharmacotherapeutic group
Cough and cold remedies. Expectorants, except combination preparations containing antitussives. Expectorants. ATX code R05CA12.
Pharmacological properties
Pharmacodynamics
Herbion® Ivy Syrup contains dry ivy leaf extract, which acts as a mucolytic, antispasmodic and bronchodilator. The main ingredients of dry ivy leaf extract are triterpene saponins, mainly hederacoside C and alpha-hederin. The mechanism of action is unknown.
Pharmacokinetics
There are no available data on the pharmacokinetic properties of dry ivy leaf extract.
Indication
– Acute inflammatory diseases of the respiratory tract accompanied by cough;
– symptomatic treatment of chronic inflammatory diseases of the bronchi.
Contraindication
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 drugs.
Interaction with other medicinal products and other types of interactions
No interaction studies have been conducted.
Application features
It is not recommended to use simultaneously with antitussive drugs, such as codeine or dextramethorphan, without consulting a doctor. It should be used with caution in patients with gastritis or stomach ulcers. If shortness of breath, fever or purulent sputum occurs, it is necessary to consult a doctor regarding further use of the drug.
Children
Herbion® ivy syrup is contraindicated in children under 2 years of age (see the “Contraindications” section).
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 of the simultaneous intake of products containing sorbitol (or fructose) and the consumption of sorbitol (or fructose) with food should be taken into account. Sorbitol may affect the bioavailability of other medicinal products used simultaneously.
Patients with rare hereditary problems of fructose intolerance should not take the medicine.
Sorbitol (≥ 140 mg/kg/day) may cause gastrointestinal discomfort and a slight laxative effect.
If the drug is used according to instructions, the patient will receive:
up to 0.875 g of sorbitol with each dose of 2.5 ml of syrup, which corresponds to 0.073 bread units;
up to 1.750 g of sorbitol with each dose of 5 ml of syrup, which corresponds to 0.146 bread units;
up to 2.625 g of sorbitol with each dose of 7.5 ml of syrup, which corresponds 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 medicinal 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 sodium (23 mg) per 5 ml, i.e. it is practically sodium-free.
Use during pregnancy or breastfeeding
The drug is not recommended for use during pregnancy or breastfeeding due to lack of sufficient data. There are no data on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted on the effect of the drug Herbion® ivy syrup on the ability to drive a car or use other mechanisms.
Method of administration and doses
Adults and children over 12 years of age: 5 ml of syrup 3 times a day (corresponding to 105 mg of dry ivy leaf extract per day).
Children aged 6 to 11 years: 5 ml of syrup 2 times a day (corresponding to 70 mg of dry ivy leaf extract per day).
Children aged 2 to 5 years: 2.5 ml of syrup 3 times a day (corresponding to 52.5 mg of dry ivy leaf extract per day).
The syrup should be used with a measuring spoon with a graduation of 2.5 ml. A measuring spoon holds 5 ml of syrup, ½ measuring spoon holds 2.5 ml of syrup.
The syrup should be taken in the morning, afternoon, and evening.
Do not exceed the recommended daily dose of the drug.
The drug should be taken regardless of food intake.
The duration of treatment depends on the nature and severity of the disease. Treatment usually lasts 7 days. If symptoms persist for more than one week during treatment with the drug, you should consult a doctor.
Children
The drug is contraindicated in children under 2 years of age (see section "Contraindications").
Overdose
Overdose can cause nausea, vomiting, diarrhea, and agitation.
Do not take doses exceeding the recommended ones. In case of overdose, consult a doctor immediately. Treatment is symptomatic. One case of overdose has been reported in a 4-year-old child who developed aggression and diarrhea after accidentally ingesting an ivy extract in an amount corresponding to 1.8 g of the plant substance (equivalent to approximately 7–10 measuring spoons of the medicinal product Herbion® Ivy Syrup).
Adverse reactions
Gastrointestinal disorders: gastrointestinal disorders (including nausea, vomiting, diarrhea) - frequency unknown.
On the part of the immune system: allergic reactions (urticaria, skin rash, couperose, dyspnea, anaphylactic reactions) - frequency unknown.
In case of severe side effects, treatment should be discontinued.
Reporting of suspected adverse reactions
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
After opening the bottle, the syrup can be used for no more than 3 months.
Storage conditions
The medicinal product does not require any special storage conditions. 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.
Vacation category
Without a prescription.
Producer
KRKA, dd, Novo mesto/KRKA, dd, Novo mesto.
Location of the manufacturer and address of its place of business
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
