Iberogast

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Iberogast, Oral Liquid

Read the Leaflet Carefully Before Using the Medicinal Product, as it Contains

Important Information for the Patient.
This medicinal product should always be used exactly as described in the package leaflet for the patient or as directed by the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 7 days there is no improvement or the patient feels worse, the doctor should be contacted.

Table of Contents of the Leaflet

• 1. What is Iberogast and what is it used for
• 2. Important information before using Iberogast
• 3. How to use Iberogast
• 4. Possible side effects
• 5. How to store Iberogast
• 6. Contents of the packaging and other information

1. What is Iberogast and what is it used for

Iberogast is a herbal medicinal product used for the treatment of functional gastrointestinal disorders related to the motility of the gastrointestinal tract, such as functional dyspepsia or irritable bowel syndrome. These disorders are mainly characterized by abdominal and intestinal cramps, abdominal pain, feeling of fullness, bloating, nausea, and heartburn.
Iberogast alleviates the feeling of fullness, bloating, and reduces stomach and intestinal cramps. It has anti-inflammatory, carminative, antioxidant, and antibacterial properties.

2. Important information before using Iberogast

When not to use Iberogast

If the patient is allergic to any of the ingredients of this medicinal product.
It is not recommended for children under 6 years of age. In children under 6 years of age, any abdominal pain should be consulted with a doctor.
If the patient has or has had liver disease or is taking medicines that, according to the patient information leaflet, may cause side effects in the form of liver damage. In case of any doubts, the doctor or pharmacist should be consulted.

Warnings and precautions

If the patient experiences yellowing of the skin or eyes, dark urine, pale stools, or abdominal pain, the use of Iberogast should be stopped immediately and a doctor consulted. These may be symptoms of liver damage.
Patients with diagnosed liver disease should consult a doctor before starting to use Iberogast.
If after 7 days there is no improvement or the patient feels worse, the doctor should be contacted to rule out other serious diseases.

Iberogast and other medicinal products

The doctor or pharmacist should be informed about all medicinal products currently being taken or recently taken by the patient, as well as any medicinal products that the patient plans to take.
No interactions are known.

Iberogast and alcohol

Due to the alcohol content, Iberogast is not intended for and should not be used by individuals with alcohol dependence.
Iberogast contains ethanol (alcohol) at a volume concentration of approximately 31%. A single dose for adults (20 drops) contains up to 240 mg of ethanol, which corresponds to approximately 6.2 ml of beer or 2.6 ml of wine per dose.
Children and individuals at high risk, including patients with liver disease or epilepsy, should consult a doctor before using Iberogast.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicinal product.
As a precaution, the use of Iberogast during pregnancy is not recommended.

Driving and using machines

A single dose for adults contains up to 240 mg of alcohol (ethanol). If Iberogast is used as recommended, it should not have a significant impact on the ability to drive vehicles and operate machinery (see the section "Iberogast and alcohol").

3. How to use Iberogast

This medicinal product should always be used exactly as described in the package leaflet for the patient or as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Instructions for the first use of the dropper

Unscrew the white-green
Screw the green
Make sure the
cap and discard the white
cap tightly to insert the
dropper is well
part.
into the bottle.
When dosing, hold the bottle with the dropper at a 45° angle. After use, close the green cap tightly.
Oral administration.
Unless otherwise directed by the doctor, Iberogast should be taken in a small amount of liquid before or during meals.
The recommended dose of Iberogast is:

• adults and adolescents over 12 years: 3 times a day, 20 drops each,
• children from 6 to 12 years: 3 times a day, 15 drops each,
• children under 6 years: not recommended.

Duration of use:

If after 7 days of using the medicinal product the symptoms do not improve, the doctor should be consulted about their cause.

Shake before use.

The presence of sediment or cloudiness does not affect the efficacy of the Iberogast liquid.

Use of a higher than recommended dose of Iberogast

There are no reports of acute overdose. However, the alcohol content should be considered.
Accidental ingestion of one or two doses of Iberogast more than recommended, i.e., a total of 40 to 60 drops, usually does not lead to negative consequences. In the case of ingestion of significantly larger doses, a doctor or pharmacist should be consulted for help.

Missed dose of Iberogast

In the event of a missed dose of Iberogast, the next scheduled dose should be waited for and the prescribed dose taken as directed by the doctor or as stated in this leaflet in the section on dosing.
A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicinal products, Iberogast can cause side effects, although not everybody gets them.
In very rare cases (less than 1 in 10,000), hypersensitivity reactions such as skin reactions, itching, or shortness of breath may occur.
Frequency not known: cases of liver damage (increased liver function test values, drug-induced jaundice, hepatitis, and liver failure) have been reported; if symptoms such as yellowing of the skin or eyes, dark urine, and pale stools occur, Iberogast should be stopped immediately and a doctor consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of the medicinal product.

5. How to store Iberogast

Store in a temperature below 25°C.
Keep out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Shelf life after first opening of the immediate packaging: 8 weeks.
Medicinal products should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicinal products that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Iberogast contains

100 ml of liquid contains:
Iberis amara herbae extractum(extract of bitter candytuft herb) (1:1.5 – 2.5) 15.0 ml
extractant – ethanol 50% (v/v)
Angelicae radicis extractum(extract of angelica root)
(1:2.5 – 3.5) 10.0 ml
extractant – ethanol 30% (v/v)
Matricariae flos extractum(extract of chamomile flowers)
(1:2 – 4)
20.0 ml
extractant – ethanol 30% (v/v)
Carvi fructus extractum(extract of caraway fruit)
(1:2.5 – 3.5) 10.0 ml
extractant – ethanol 30% (v/v)
Silybi mariani fructus extractum(extract of milk thistle fruit) (1:2.5 – 3.5)
10.0 ml
extractant – ethanol 30% (v/v)
Melissae folii extractum(extract of lemon balm leaves)
(1:2.5 – 3.5) 10.0 ml
extractant – ethanol 30% (v/v)
Menthae piperitae folii extractum(extract of peppermint leaves) (1:2.5 – 3.5) 5.0 ml
extractant – ethanol 30% (v/v)
Chelidonii herbae extractum(extract of celandine herb)
(1:2.5 – 3.5) 10.0 ml
extractant – ethanol 30% (v/v)
Liquiritiae radicis extractum(extract of licorice root)
(1:2.5 – 3.5)
10.0 ml
extractant – ethanol 30% (v/v)
Iberogast contains 29.5 – 32.6 % (v/v) ethanol.

What Iberogast looks like and what the packaging contains

Bottle made of dark glass with a dropper and screw cap, in a cardboard box.
The packaging contains 20 ml of Iberogast liquid.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Bulgaria, the country of export:

Bayer Bulgaria EOOD
5 Rezbarska Str.
1510 Sofia
Bulgaria

Manufacturer:

Steigerwald Arzneimittelwerk GmbH
Havelstrasse 5
64295 Darmstadt
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20060714
Parallel import authorization number:1/19

Date of approval of the leaflet: 15.12.2023

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