Herbion lozenges for sucking
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Herbion lozenges
Dry extract of Hedera helix (ivy) leaf
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Leaflet contents
- What Herbion is and what it is used for
- What you need to know before taking Herbion
- How to take Herbion
- Possible adverse effects
- How to store Herbion
- Contents of the pack and other information
1. What Herbion is and what it is used for
Herbion contains dry extract of ivy leaf.
Herbion is a herbal medicinal product used as an expectorant for productive cough in adults, adolescents, and children from 6 years of age.
2. What you need to know before starting to take Herbion
Do not take Herbion
- If you are allergic to ivy leaf extract (Hedera helix L.), to any component of the araliaceae family, or to any of the ingredients of this medicine (listed in section 6).
Do not administer this medicine to children under 2 years of age, as there is a risk that respiratory symptoms may worsen.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Herbion:
- If you have difficulty breathing, fever, or purulent (pus-containing) secretions, consult your doctor or pharmacist.
- If symptoms worsen or do not improve after 7 days of using the medicine, consult your doctor.
- Simultaneous use with other antitussives (such as codeine or dextromethorphan) is not recommended without consulting your doctor.
- If you have stomach problems (gastritis, stomach ulcers), this medicine should be administered with caution.
- If you suffer from renal or hepatic impairment, consult your doctor or pharmacist before taking Herbion lozenges. There are no data available to recommend a dose for these patients.
Children
The use of Herbion lozenges is not recommended in children aged 2 to 5 years, as the dose cannot be adjusted with the lozenge formulation. For this age group, a syrup formulation is recommended.
In children between 2 and 4 years of age with persistent or recurrent cough, a medical diagnosis is required before starting treatment.
Other medicines and Herbion
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
There have been no reports of interactions between ivy leaf dry extract and other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Herbion is not recommended during pregnancy or breastfeeding due to lack of data on the use of ivy extract in pregnant or breastfeeding women.
Driving and use of machines
No studies have been conducted on the ability to drive and use machinery.
Herbion contains isomaltose (type M) (E953) and butylated hydroxyanisole (E320)
This medicine contains isomaltose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylated hydroxyanisole.
3. How to take Herbion
Follow exactly the administration instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose for adults, elderly patients, and adolescents over 12 years of age is 1 lozenge, taken 3 times a day.
Use in children
The usual dose for children aged 6 to 11 years is 1 lozenge, taken 2 times a day.
The use of Herbion lozenges is not recommended in children under 6 years of age.
Allow the lozenge to dissolve in the mouth. Do not take the lozenges immediately before or during meals.
It is recommended to drink plenty of water or other hot, caffeine-free beverages while taking Herbion.
If symptoms persist for more than 1 week during treatment with this medicine, consult your doctor or pharmacist.
If you take more Herbion than you should
Do not take more than the recommended dose. Taking higher doses than recommended (more than double the daily dose) may cause nausea, vomiting, diarrhea, and agitation. Treatment is symptomatic.
If you forget to take Herbion
Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
With unknown frequency (frequency cannot be estimated from the available data):
- nausea, vomiting, diarrhoea.
- allergic reaction manifested as urticaria, skin rash and difficulty breathing (dyspnoea).
- severe allergic reaction (anaphylactic reaction), which may manifest as swelling of the mouth, tongue, face and/or throat, difficulty breathing or swallowing (chest tightness or wheezing).
If you experience an allergic reaction, stop taking the medicine and consult your doctor. In the case of a severe allergic reaction, seek immediate medical attention.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Herbion
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Herbion
- The active substance is a dry extract of ivy leaf. Each lozenge contains 35 mg of extract (as dry extract) from Hedera helix L., folium (ivy leaf) (5–7.5:1).
Extraction solvent: ethanol 30% (m/m).
- The other components are: isomaltulose (type M) (E953), citric acid, natural caramel flavour (propylene glycol (E1520)), natural citrus flavour (butylated hydroxyanisole (E320)), sucralose (E955) and peppermint oil. See section 2 “Herbion contains isomaltulose (type M) (E953) and butylated hydroxyanisole (E320)”.
- Excipient used in the extract: simethicone.
Appearance of the product and contents of the pack
The lozenges are light brown to brown in colour, round, with bevelled edges and a rough surface. They may contain yellow to brown particles, lighter areas, air bubbles, and slightly serrated edges. Diameter of the lozenges: 18.0 mm – 19.0 mm, thickness: 7.0 mm – 8.0 mm.
The medicine is packaged in blisters (PVC/PE/PVDC-Al), available in pack sizes of 8, 16 and 24 lozenges.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA d.d. Novo mesto Smarjeska cesta 6 8501 Novo mesto, Slovenia
For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Krka Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain
This medicine is authorized in the Member States of the European Economic Area under the following names:
Member State | Medicinal product name |
Slovenia | List navadnega bršljana Krka pastile |
Spain | Herbion pastillas para chupar |
Croatia | Herbion pastile od bršljana |
Portugal | Herbihelix Expetorante |
Date of the most recent review of this leaflet: February 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.