PATIENT INFORMATION LEAFLET

Iberogast

Oral drops in solution

Ethanolic liquid extracts of white hawthorn, angelica roots, chamomile flowers, caraway fruits, globe thistle fruits, melissa leaves, peppermint leaves, celidonia, licorice root.

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 indicated 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen, or if you do not improve after 7 days of treatment.

1. What Iberogast is and what it is used for

2. What you need to know before taking Iberogast

3. How to take Iberogast

4. Possible side effects

5. Storage of Iberogast

6. Contents of the pack and additional information

Iberogast is a plant-based medicationcontaining liquid ethanol extracts of white hawthorn, angelica roots, chamomile flowers, caraway fruits, blessed thistle fruits, lemon balm leaves, peppermint leaves, celadine, and licorice root.

This medication is indicated for the treatment of gastrointestinal disorders such as dyspepsia(digestive disorder)and gastritis(stomach inflammation), as well as relief of associated symptoms, stomach pain, abdominal bloating, flatulence, gastrointestinal cramps, nausea, and stomach burning.

Iberogast is indicated for adults and adolescents over 12 years old.

Consult a doctor if symptoms worsen, or if no improvement is seen after 7 days of treatment.

Do not take Iberogast

If you are allergic to the active ingredients or any other component of this medication (Included in section 6).

If you have or have had liver disease or if you are taking medications that include liver damage as a side effect in the prospect. In case of doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor, pharmacist, or nurse if symptoms persist or if no expected results are obtained despite treatment.

Be aware of signs and symptoms that may indicate that your liver is not functioning properly.

If you notice that your skin or eyes are yellowish, your urine is dark, your stools are discolored, or you have pain in the upper abdomen, immediately stop treatment with Iberogast and consult your doctor. These may be symptoms of liver damage.

Children and Adolescents

Children under 12 years old should not use this medication, as there is not enough clinical information available.

If your symptoms do not improve in 7 days or even worsen, consult your doctor to rule out other serious diseases.

Other medications and Iberogast

No interactions with other medications are known to date.

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

Taking Iberogast with food and drinks

No interactions with food and drinks are known.

Pregnancy, breastfeeding, and fertility

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

No studies have been conducted to establish the safety of using this medication during pregnancy or breastfeeding, so it should not be administered in these circumstances.

Driving and operating machines

Iberogast contains ethanol (alcohol). It does not appear that the recommended doses of the medication will alter the ability to drive or operate machines. However, it may reduce reaction time, so it is not recommended to drive vehicles or operate machinery that requires special attention until it is confirmed that the ability to perform these tasks is not affected.

Important information about certain ingredients in Iberogast

Iberogast contains 31% (V/V) of ethanol (alcohol), an amount corresponding to

240 mg of ethanol in 20 drops (per unit dose), which is equivalent to 6.2 ml of beer or 2.6 ml of wine. This medication is harmful to people with alcoholism. The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk populations, such as patients with liver disease or epilepsy.

Iberogast contains less than 0.1 UC per 20 drops (unit dose).

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The usual recommended dose is:

Adults and adolescents over 12 years: take 20 drops of Iberogast, 3 times a day before or during meals, with a little liquid. The bottle should be tilted during dripping (at a 45° angle).

If symptoms persist or worsen after 7 days of treatment, consult your doctor.

After 2 months of using the medication, consult your doctor about the possibility of continuing treatment. The duration of treatment depends on the type, severity, and evolution of the disease.

Remember to shake the medication before using it.

Use in children and adolescents:

This medication is not recommended for children under 12 years.

If you take more Iberogast than you should:

Up to now, there have been no cases of acute overdose. However, consider the alcohol content present in the product.

In case of overdose, the adverse effects may be potentiated. In case of accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forget to take Iberogast:

If you have forgotten to take Iberogast, the next dose will be taken according to the instructions in this leaflet or in accordance with the dose indicated by your doctor. Do not take a double dose to compensate for the missed dose.

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

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

Very Rare(may affect up to 1 in 10,000 people): hypersensitivity reactions such as skin rashes, itching, or difficulty breathing.

Frequency Not Known(cannot be estimated from available data): liver damage (elevated liver enzymes, medication-related jaundice, hepatitis, and liver insufficiency) has been reported; if you notice symptoms such as yellowing of the skin or eyes, dark urine, or dark-colored stools, you should immediately stop taking Iberogast and consult your doctor.

If you experience a medication reaction, you should discontinue medication administration and seek immediate medical attention. Your doctor will evaluate the severity of the reaction and determine any additional necessary measures.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not described in this prospectus.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed 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 store at a temperature above 25 °C.

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.

Consume Iberogast within 8 weeks after the first opening of the packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Iberogast

Each ml of oral drops (equivalent to 20 drops) contains:

Alcoholic liquid extract (50% (V/V)):

0.15 ml of fresh plant material ofIberis amara L, white clover (1:1.5-2.5);

Alcoholic liquid extracts (30% (V/V)):

0.2 ml of flowers ofMatricaria recutita L, chamomile (1: 2-4);

0.1 ml of root ofAngelica archangelica L, angelica (1: 2.5-3.5);

0.1 ml of fruit ofCarum carvi L, caraway (1: 2.5-3.5);

0.1 ml ofChelidonium majus L, celandine (1: 2.5-3.5);

0.1 ml of root ofGlycyrrhiza glabra L, licorice (1: 2.5-3.5);

0.1 ml of leaf ofMelissa officinalis L, lemon balm (1: 2.5-3.5);

0.1 ml of fruit ofSilybum marianum L Gaertner, milk thistle (1: 2.5-3.5) and

0.05 ml of leaf ofMentha piperita L, peppermint (1: 2.5-3.5)

The other components (excipients) are:

The medicinal product contains a 31% (V/V) of ethanol.

Appearance of the product and contents of the container

Brownish dark liquid, transparent or slightly turbid with a characteristic odor and bitter taste.

Due to the characteristics of the medicinal product, Iberogast may present precipitates or turbidity. If this occurs, it will not affect the efficacy of the preparation.

The medicinal product is presented in a glass amber bottle with a dropper and a screw cap. It is available in 3 container sizes: 20 ml, 50 ml and 100 ml

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing:

Steigerwald Arzneimittelwerk GmbH

Havelstrasse 5

Darmstadt D-64295

Germany

Last review date of this leaflet: April 2019

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/”

INSTRUCTIONS FOR USE OF THE DROPPER