Instructions for Herbion ivy lollipops 35 mg No. 16
Composition
active ingredient: dry ivy leaf extract;
1 lollipop contains 35 mg of dry ivy leaf extract (5−7.5:1 (Hedera helix L., folium extractum siccum);
extractant: ethanol 30% (m/m);
excipients: isomalt (type M) (E 953), citric acid, natural caramel flavor (contains propylene glycol), natural citrus flavor (contains butylhydroxyanisole), sucralose, peppermint oil.
Dosage form
Lollipops.
Main physicochemical properties: round lollipops with beveled, slightly serrated edges and an uneven surface from light brown to brown with possible inclusions from yellow to brown particles, lighter spots, air bubbles.
Pharmacotherapeutic group
Medicines used for coughs and colds. Expectorant. ATX code R05CA12.
Pharmacological properties
Pharmacodynamics
Herbion® Ivy, lollipops, is a herbal medicinal product based on 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.
Alpha-hederin inhibits the endocytosis of beta2-adrenergic receptors, which increases the activity of beta2-adrenergic cells in the bronchial mucosa and lung epithelium. This leads to a decrease in intracellular calcium levels in the bronchial mucosa, which causes bronchial relaxation. By stimulating beta2-adrenergic receptors, alveolar epithelial type II cells produce more surfactant, which leads to a decrease in mucus viscosity. Thus, expectoration and coughing are facilitated.
Pharmacokinetics
There are no available data on the pharmacokinetic properties of dry ivy leaf extract.
Indication
Herbion® Ivy, Lollipops is a herbal medicine used as an expectorant for productive cough in adults and children over 6 years of age.
Contraindication
Hypersensitivity to the active substance or to other plants of the Araliaceae family, or to any other component of the drug; children under 6 years of age.
Interaction with other drugs and other types of interactions.
There have been no reports of the effects of dry ivy leaf extract on other drugs. No interaction studies have been conducted.
Interaction with other medicinal products and other types of interactions
There have been no reports of the effects of dry ivy leaf extract on other drugs. No interaction studies have been conducted.
Application features
If you are concerned about shortness of breath, increased body temperature, or purulent sputum, you should consult a doctor.
Concomitant use with antitussives such as codeine or dextramethorphan is not recommended without consulting a doctor. It should be used with caution in patients with gastritis or stomach ulcers.
Lozenges are contraindicated in children under 6 years of age, as it is impossible to properly select the dose of the drug in this dosage form. There is a syrup for children aged 2 to 5 years. Products containing dry ivy leaf extract are contraindicated in children under 2 years of age due to the risk of worsening respiratory symptoms, which is inherent in all secretolytic agents.
Herbion® Ivy lollipops do not contain sugar.
Herbion® Ivy Lollipops contain isomalt (E 953). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies on the effects on the ability to drive and use machines have been conducted.
Use during pregnancy or breastfeeding
It is not recommended to use the drug during pregnancy or breastfeeding due to the lack of sufficient data.
Method of administration and doses
Adults and children over 12 years of age: 1 lollipop 3 times a day (corresponding to 105 mg of dry ivy leaf extract per day).
Children aged 6 to 11 years: 1 lollipop 2 times a day (corresponding to 70 mg of dry ivy leaf extract per day).
Patients with renal and hepatic impairment
There are no data on dose adjustment.
Method of application
The lollipop should be slowly dissolved in the mouth.
During treatment with the drug, it is recommended to drink plenty of water or other warm, caffeine-free beverages.
You should not suck on the lollipop immediately before or during a meal.
If symptoms persist for longer than 1 week after the start of use, you should consult a doctor.
Children
The drug is contraindicated in children under 6 years of age.
Overdose
An overdose was reported in a 4-year-old child after accidental ingestion of a large amount of ivy extract (approximately 7-10 lozenges, equivalent to 1.8 g of ivy leaves), which was accompanied by aggression and diarrhea.
Adverse reactions
Adverse reactions that may occur during treatment with Herbion® Ivy lollipops are grouped according to frequency: very common ≥ 1/10; common ≥ 1/100 − < 1/10; uncommon ≥ 1/1000 − < 1/100; rare ≥ 1/10000 − < 1/1000; very rare < 1/10000; frequency unknown (cannot be estimated from available data).
| Organ system classes | Frequency unknown |
| On the part of the immune system | Allergic reactions (urticaria, skin rash, dyspnea, anaphylactic reaction) |
| Gastrointestinal tract | Nausea, vomiting, diarrhea |
In case of severe side effects, treatment should be discontinued.
Report of expected adverse reactions
Reporting of suspected adverse reactions after the registration of a medicinal product is important. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Information on any suspected adverse reactions should be submitted in accordance with legal requirements.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging in order to protect from moisture. Keep out of the reach of children.
Packaging
8 lollipops in a blister, 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
KRKA, PhD, Novo mesto.
Location of the manufacturer and its business address
Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
