HERBION LOZENGES

Introduction

Package Leaflet: Information for the Patient

Herbion Lozenges

Dry extract of Hedera helix (ivy) leaf

Read this entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What is Herbion and what is it used for
2. What you need to know before taking Herbion
3. How to take Herbion
4. Possible side effects
5. Storage of Herbion
6. Package Contents and Additional Information

1. What is Herbion and what is it used for

Herbion contains dry extract of ivy leaf.

Herbion is a herbal medicine used as an expectorant for productive cough in adults, adolescents, and children from 6 years of age.

2. What you need to know before taking Herbion

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 your symptoms worsen or do not improve after 7 days of using the medication, consult your doctor.
• Concomitant 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 medication should be administered with caution.
• If you have kidney or liver failure, consult your doctor or pharmacist before taking Herbion lozenges. There are no data for dosage recommendations in these patients.

Children

The use of Herbion lozenges is not recommended in children from 2 to 5 years of age, as it is not possible to adjust the dose in the lozenge formulation. In this age range, 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 Medications and Herbion

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

No interactions have been reported between dry ivy leaf extract and other medications.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 Using Machines

No studies have been conducted on the ability to drive and use machines.

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

This medication contains isomaltose. If your doctor has told you 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.

3. How to Take Herbion

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

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

Use in Children

The usual dose for children from 6 to 11 years of ageis 1 lozenge, 2 times a day.

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

Dissolve the lozenge in your mouth. Do not take the lozenges immediately before or during meals.

It is recommended to drink plenty of water or other hot, non-caffeinated beverages while taking Herbion.

If your symptoms persist for more than 1 week during the use of this medication, 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 other questions about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

• nausea, vomiting, diarrhea.
• allergic reaction manifesting as hives, skin rash, and difficulty breathing (dyspnea).
• severe allergic reaction (anaphylactic reaction), which can 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 medication and consult your doctor. In the case of a severe allergic reaction, go to an emergency doctor.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Herbion

Keep this medication out of sight and reach of children.

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

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Herbion

• The active ingredient 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).

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

• The other ingredients are: isomaltose (type M) (E953), citric acid, natural caramel flavor (propylene glycol (E1520)), natural citrus flavor (butylhydroxyanisole (E320)), sucralose (E955), and peppermint oil. See section 2 "Herbion contains isomaltose (type M) (E953) and butylhydroxyanisole (E320)".
• Excipient used in the extract: simethicone.

Appearance of the Product and Package Contents

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Krka Farmacéutica, S.L., C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet:February 2024

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