IBEROGAST ELEMENTAL ORAL SOLUTION DROPS

Introduction

Package Leaflet: Information for the User

Iberogast Elementaloral drops in solution

Read the entire package 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 package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this package leaflet. See section 4.
• You should consult a doctor if you do not improve or if you worsen after 7 days.

Contents of the Package Leaflet

1. What Iberogast Elemental is and what it is used for
2. What you need to know before taking Iberogast Elemental
3. How to take Iberogast Elemental
4. Possible side effects
5. Storage of Iberogast Elemental
6. Package contents and additional information

1. What Iberogast Elemental is and what it is used for

Iberogast Elemental is a herbal medicine for the symptomatic treatment of functional dyspepsia with main symptoms such as stomach pain, burning in the upper abdomen, fullness after eating, and early satiety, but often also loss of appetite, excessive belching, and stomach acidity.

Iberogast Elemental is indicated in adults from 18 years of age.

You should consult a doctor if you do not improve or if you worsen after 7 days.

2. What you need to know before taking Iberogast Elemental

Do not take Iberogast Elemental

If you are allergic to the active ingredients (white horehound, chamomile flowers, caraway fruit, lemon balm leaves, peppermint leaves, or licorice root) or to other plants of the apiaceae or asteraceae families.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Iberogast Elemental.

Consult your doctor or pharmacist if your symptoms persist after 7 days or if new symptoms appear, to ensure that there is no underlying disease.

Children and adolescents

The use of Iberogast Elemental has not been established in children and adolescents under 18 years of age due to the lack of sufficient data. Therefore, its use is not recommended in children and adolescents.

Other medications and Iberogast Elemental

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

No interactions with other medications are known.

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.

There are no data or limited data on the use of Iberogast Elemental in pregnant women. As a precautionary measure, it is preferable to avoid the use of Iberogast Elemental during pregnancy.

There is insufficient information on the excretion of Iberogast Elemental's active ingredients or their metabolites in breast milk. The risk to breastfed infants cannot be excluded. Consult your doctor.

Driving and using machines

Iberogast Elemental's influence on the ability to drive and use machines is nil or insignificant.

Iberogast Elemental contains ethanol

This medication contains 240 mg of alcohol (ethanol) in 20 drops. The amount in a dose (20 drops/1 ml) of this medication is equivalent to less than 7 ml of beer or 3 ml of wine. The small amount of alcohol present in this medication will have no noticeable effect.

3. How to take Iberogast Elemental

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is

Adults from 18 years of age:

20 drops 3 times a day

Patients with reduced renal or hepatic function:

There are insufficient data to recommend specific doses in case of reduced renal or hepatic function.

Method of administration

Take with some liquid before or during meals.

Oral route

Shake before use.

Tilt the dropper bottle at a 45° angle when dispensing. Close tightly with the purple cap after use.

Instructions for the first use of the dropper

Duration of use

If symptoms persist during the use of the medication, you should consult a doctor or pharmacist after 7 days (also read the warnings in section 2: What you need to know before taking Iberogast Elemental).

Use in children and adolescents

The use of Iberogast Elemental has not been established in children and adolescents under 18 years of age due to the lack of sufficient data. Therefore, its use is not recommended in children and adolescents.

If you take more Iberogast Elemental than you should

If you have accidentally taken more drops than recommended, this should not have a negative effect. If you have taken a significantly higher dose than recommended, consult your doctor.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Iberogast Elemental

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

Allergic reactions with symptoms such as difficulty breathing or skin reactions, such as itching or rash, may occur. According to available data, the frequency is unknown (cannot be estimated from available data).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet.

You can also report them directly through the Spanish Medication Surveillance 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 Iberogast Elemental

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

Do not use this medication after the expiration date shown on the box and bottle after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

This medication can be used for 8 weeks after opening the bottle for the first time.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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 Iberogast Elemental

The active ingredients are:

1 ml contains:

0.15 ml of white horehound liquid extract, whole plant (Iberis amara L., planta tota recens) (1:1.5-2.5), extraction solvent ethanol 50% V/V

0.30 ml of chamomile flower liquid extract (Matricaria recutita L., flos) (1:2-4), extraction solvent ethanol 30% V/V

0.20 ml of caraway fruit liquid extract (Carum carvi L., fructus) (1:2.5-3.5), extraction solvent ethanol 30% V/V

0.15 ml of lemon balm leaf liquid extract (Melissa officinalis L., folium) (1:2.5-3.5), extraction solvent ethanol 30% V/V

0.10 ml of peppermint leaf liquid extract (Mentha piperita L., folium) (1:2.5-3.5), extraction solvent ethanol 30% V/V

0.10 ml of licorice root liquid extract (Glycyrrhiza species, radix) (1:2.5-3.5), extraction solvent ethanol 30% V/V

Total ethanol content 31% V/V

1 ml = 20 drops

Appearance of the product and package contents

Iberogast Elemental is a dark brown liquid, clear to slightly turbid, packaged in amber glass bottles with a closure system that includes a dropper and a screw cap.

Package sizes: 20 ml, 50 ml, or 100 ml.

Not all package sizes may be marketed.

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Steigerwald Arzneimittelwerk GmbH

Havelstraße 5

64295 Darmstadt

Germany

This medication has been authorized in the member states of the European Economic Area under the following names:

Austria: Iberogast SELECT Tropfen zum Einnehmen

Belgium: Iberogas druppels voor oral gebruik, vloeistof / liquide oral en gouttes / Tropfen zum Einnehmen, Flüssigkeit

Cyprus: Iberogast N

Czech Republic: Iberogast NEO

Greece: Iberogast N

Italy: IBEROGASTADVANCE

Luxembourg: Iberogas druppels voor oral gebruik, vloeistof / liquide oral en gouttes / Tropfen zum Einnehmen, Flüssigkeit

Netherlands: Iberogast Select

Spain: Iberogast Elemental oral drops in solution

Date of the last revision of this package leaflet{April 2023}.

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