Herbion® Hedera (Tablets, Syrup) Instructions for Use
ATC Code
R05CA12 (Hederae Helix folia)
Active Substance
Hederae Helix folia (Grouping Name)
Clinical-Pharmacological Group
Herbal preparation with expectorant effect
Pharmacotherapeutic Group
Drugs used for cough and colds; expectorants, excluding combinations with antitussives; mucolytic agents
Pharmacological Action
Herbal remedy. It has an expectorant, mucolytic, and antispasmodic effect due to the presence of saponins.
Indications
Use as an expectorant in the complex therapy of infectious and inflammatory diseases of the respiratory tract.
- Administer for conditions accompanied by a cough with difficult-to-discharge sputum.
ICD codes
| ICD-10 code | Indication |
| J04 | Acute laryngitis and tracheitis |
| J06.9 | Acute upper respiratory infection, unspecified |
| J15 | Bacterial pneumonia, not elsewhere classified |
| J20 | Acute bronchitis |
| J37 | Chronic laryngitis and laryngotracheitis |
| J42 | Unspecified chronic bronchitis |
| R05 | Cough |
| R09.3 | Sputum |
| ICD-11 code | Indication |
| CA05 | Acute laryngitis or tracheitis |
| CA07.0 | Acute upper respiratory tract infection of unspecified site |
| CA0G | Chronic laryngitis or laryngotracheitis |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA40.0Z | Bacterial pneumonia, unspecified |
| CA42.Z | Acute bronchitis, unspecified |
| MD10 | Abnormal sputum |
| MD12 | Cough |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Take orally. Determine the dose, frequency, and duration of treatment individually, based on the clinical situation, the patient’s age, and the specific dosage form used.
Adhere strictly to the dosing instructions provided with the specific product packaging for the tablet or syrup formulation.
Adverse Reactions
Possible adverse reactions include allergic reactions, nausea, vomiting, and diarrhea.
Rarely, pain in the epigastric region may occur. Discontinue use and consult a physician if any adverse reactions are severe or persistent.
Contraindications
- Do not use in patients with known hypersensitivity to ivy (Hedera helix) or any other component of the product.
- Contraindicated in specific pediatric age groups depending on the dosage form; consult the product leaflet for age restrictions.
Use in Pregnancy and Lactation
Not recommended for use during pregnancy and lactation.
Pediatric Use
Use in children of appropriate age categories is possible according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the leaflets for ivy preparations regarding contraindications for the use of specific dosage forms of this product in children of different ages.
Special Precautions
During treatment, it is recommended to consume a sufficient amount of warm fluids (water, tea, etc.).
If there is no effect during treatment with the product for 5-7 days and/or if the condition worsens (appearance of asthma attacks, purulent sputum, fever), it is necessary to consult a doctor.
Drug Interactions
Avoid concomitant use with antitussive medications (e.g., codeine, dextromethorphan). This combination impedes the clearance of liquefied sputum and can increase the risk of respiratory complications.
No other clinically significant drug interactions are known.
Overdose
Symptoms of overdose may include nausea, vomiting, diarrhea, and gastritis due to the saponin content.
In case of suspected overdose, discontinue the medication immediately and initiate symptomatic and supportive treatment. Gastric lavage may be considered if a large amount was ingested recently.
Storage Conditions
Store at 8°C (46°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Lozenges 35 mg: 8, 16, 24, 32, or 40 pcs.
Marketing Authorization Holder
Krka d.d., Novo mesto (Slovenia)
Dosage Form
 |
Herbion® ivy | Lozenges 35 mg: 8, 16, 24, 32, or 40 pcs. |
Dosage Form, Packaging, and Composition
Lozenges from light brown to brown in color, round, with beveled edges, with a rough surface; the presence of inclusions from yellow to brown, light spots, the presence of air bubbles and slight unevenness of the edges is allowed.
| 1 tab. | |
| Extract of common ivy leaves* | 35 mg |
* produced from common ivy leaves (Hedera helix L., family Araliaceae); extractant – ethanol (ethyl alcohol) 30% (w/w).
Excipients : isomalt (type M) (E953), citric acid (E330), sucralose (E955), caramel flavor (natural flavoring substance, flavor preparation, propylene glycol (E1520), water), citrus flavor (natural flavoring substance, flavor preparation, butylated hydroxyanisole (E320)), peppermint leaf oil.
8 pcs. – blisters (1) – carton packs.
8 pcs. – blisters (2) – carton packs.
8 pcs. – blisters (3) – carton packs.
8 pcs. – blisters (4) – carton packs.
8 pcs. – blisters (5) – carton packs.
Syrup: 150 ml bottle with dosing spoon
Marketing Authorization Holder
Krka d.d., Novo mesto (Slovenia)
Dosage Form
|
Herbion® ivy syrup | Syrup: 150 ml bottle with dosing spoon |
Dosage Form, Packaging, and Composition
Syrup yellowish-brown in color with a characteristic odor; opalescence is allowed.
| 1 ml | |
| Dry extract of common ivy leaves (5-7.5:1)* | 7 mg |
* dry extract of common ivy leaves (5-7.5:1) is prepared from: common ivy leaves (common ivy Hedera helix L., family Araliaceae, folium) and ethanol 30% (extractant).
Excipients : sorbitol liquid (non-crystallizing, 70% aqueous solution) (E420) – 500 mg, glycerol (E422) – 200 mg, sodium benzoate (E211) – 2 mg, citric acid monohydrate (E330) – 0.3 mg, aromatic balsam** – 1 mg, purified water – up to 1 ml.
** Aromatic balsam contains propylene glycol (E1520), ethanol (E1510), citronella oil, citral from Litsea cubeba, lemon oil, coriander oil.
150 ml – dark glass bottles with first-opening control (1) complete with a dosing spoon – carton packs.
![Herbion® Hedera [Tablets, Syrup] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Herbion® Hedera [Tablets, Syrup] 2")