Leaflet: information for the patient

Herbion lozenges

Dried extract of Hedera helix (ivy) leaf

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side 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 get worse or do not improve after 7 days.

1.What is Herbion and what it is used for

2.What you need to know before starting to take Herbion

3.How to take Herbion

4.Possible side effects

5.Storage of Herbion

6.Contents of the pack and additional information

Herbion contains dried extract of ivy leaf.

Herbion is a plant-based medication used as an expectorant for productive cough in adults, adolescents, and children aged 6 years and above.

Do not takeHerbion

• 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 medication (listed in section 6).

Do not administer the medication to children under 2 years of age, as there is a risk of worsening respiratory symptoms.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Herbion:

• If you have difficulty breathing, fever or purulent secretions (with pus), consult your doctor or pharmacist.
• If symptoms worsen or do not improve after 7 days of medication use, consult your doctor.
• Do not recommend simultaneous use with other antitussives (such as codeine or dextromethorphan) without consulting your doctor.
• If you have stomach problems (gastritis, stomach ulcers), this medication should be administered with caution.
• If you have renal insufficiency or liver insufficiency, consult your doctor or pharmacist before taking Herbion chewable tablets. There are no data for dosage recommendations in these patients.

Children

Herbion chewable tablets are not recommended for use in children aged 2 to 5 years, as it is not possible to adjust the dose in the chewable tablet formulation. In this age range, a syrup formulation is recommended.

In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Other medications and Herbion

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

No interaction has been reported between the dry extract of ivy leaf and other medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Herbion is not recommended during pregnancy or breastfeeding due to the lack of data on the use of ivy extract in pregnant women or breastfeeding mothers.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

Herbion contains isomaltosa (type M) (E953) and butylhydroxyanisole (E320)

This medication contains isomaltosa. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole.

Follow exactly the administration instructions indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The usual dose foradults, elderly patients, and adolescents over 12 years of ageis 1 lozenge, 3 times a day.

Use in children

The usual dose forchildren aged 6 to 11 yearsis 1 lozenge, 2 times a day.

The use of Herbion lozenges is not recommended in children under 6 years of age.

Disintegrate the lozenge 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 use of this medication, consult your doctor or pharmacist.

If you take more Herbion than you should

Do not take more doses than recommended. Taking higher doses than recommended (more than double the daily dose) may cause nausea, vomiting, diarrhea, and agitation. Treatment is symptomatic.

If you have forgotten to take Herbion

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

With an unknown frequency (the frequency cannot be estimated from the available data):

• nausea, vomiting, diarrhea.
• allergic reaction manifesting as urticaria, skin rash, and difficulty breathing (dyspnea).
• 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 hyperventilation).

If you experience an allergic reaction, stop taking the medication and consult with your doctor. In the case of a severe allergic reaction, go to an emergency doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Herbion

• The active principle is a dry extract of ivy leaf. Each lozenge contains 35 mg of extract (as dry extract) of Hedera helix L., folium (ivy leaf) (5–7.5:1).

Extractant solvent with 30% (m/m) ethanol.

• The other components are: isomaltosa (type M) (E953), citric acid, natural caramel flavoring (propylenglycol (E1520)), natural citrus flavor (butylhydroxyanisole (E320)), sucralose (E955) and peppermint oil. See section 2 “Herbion contains isomaltosa (type M) (E953) and butylhydroxyanisole (E320)”.
• Excipient used in the extract: simethicone.

Appearance of the product and contents of the package

The lozenges are light brown to brown, round, with beveled edges and a rough surface. There may be yellow to brown particles, lighter areas, air bubbles, and slightly toothed edges. Diameter of the lozenges: 18.0 mm – 19.0 mm, thickness: 7.0 mm – 8.0 mm.

The medicine is presented in a blister (PVC/PE/PVDC-Al), in formats of 8, 16 and 24 lozenges.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

KRKA d.d. Novo mesto Smarjeska cesta 6 8501 Novo mesto, Slovenia

For more 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 with the following names:

Last review date of this leaflet:February 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.