Iberogast

Package leaflet: Information for the patient

Caution! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Iberogast, oral liquid
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, so that you may read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if your condition worsens after 7 days, consult your doctor.

Contents of the leaflet

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

1. What Iberogast is and what it is used for

Iberogast is a herbal medicine used for the treatment of functional gastrointestinal disorders related to gastrointestinal motility (transit), such as functional dyspepsia (indigestion) or irritable bowel syndrome. These disorders are mainly characterized by abdominal and intestinal cramping, abdominal pain, bloating, nausea, and heartburn.
Iberogast relieves bloating and the sensation of fullness, and reduces stomach and intestinal spasms. It exhibits 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 medicine.
It is not recommended for children under 6 years of age. In children under 6 years of age, any abdominal pain should be discussed with a doctor.
If the patient has or has previously had liver disease, or if the patient is taking medicines which – according to the patient leaflet – may cause adverse effects in the form of liver damage. In case of any doubts, consult a doctor or pharmacist.

Warnings and precautions
If the patient develops yellowing of the skin or eyes, dark urine, pale stools, or upper abdominal pain, treatment with Iberogast should be stopped immediately and medical advice should be sought. These may be symptoms of liver damage.
Patients with diagnosed liver disease should consult a doctor before starting treatment with Iberogast.
If there is no improvement after 7 days, or if the patient feels worse, contact a doctor to exclude other serious conditions.

Iberogast and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Interactions are not known.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
As a precautionary measure, it is recommended to avoid using Iberogast during pregnancy.

Driving and operating machinery
A single adult dose contains up to 240 mg of alcohol (ethanol). When Iberogast is used as recommended, it should not have a significant effect on the ability to drive or operate machinery (see section "Iberogast and alcohol").

3. How to use Iberogast

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, please consult your doctor or pharmacist.
Instructions for first use of the dropper

Unscrew the white-green cap and discard the white part.
Tightly screw the green part back on to secure the dropper in place.
Insert the dropper into the bottle.
When dosing, hold the bottle with the dropper at a 45° angle. After use, close tightly with the green cap.
For oral use.
Unless otherwise advised by your doctor, Iberogast should be taken diluted in a small amount of liquid, before or during meals.
The recommended dose of Iberogast is:

• Adults and adolescents over 12 years of age: 20 drops three times daily,
• Children from 6 to 12 years of age: 15 drops three times daily,
• Children under 6 years of age: not recommended.

Duration of use:
If symptoms do not improve after 7 days of treatment, consult your doctor to determine their cause.
Shake well before use.
The presence of sediment or cloudiness does not affect the efficacy of Iberogast.
Use of a higher than recommended dose of Iberogast
There are no reports of acute overdose. However, the alcohol content should generally be taken into account.
Accidentally taking one or two extra doses of Iberogast, i.e. a total of 40 to 60 drops, usually does not lead to negative consequences. If significantly larger doses are taken, seek medical advice from your doctor or pharmacist.
Missed dose of Iberogast
If you miss a dose of Iberogast, wait until the next scheduled dose and take the dose prescribed by your doctor or stated in this leaflet under "Dosage".
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
In very rare cases (less frequently than 1 in 10,000) hypersensitivity reactions such as skin reactions, itching, or shortness of breath may occur.
Frequency unknown: cases of liver damage (elevated 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, or pale stools occur, Iberogast should be discontinued immediately and medical advice should be sought.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Iberogast

Store below 25°C. Do not store in the refrigerator or freeze.
Keep out of sight and reach of children.
Shelf life after first opening the bottle: 8 weeks.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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
extraction solvent - ethanol 50% (v/v)
Angelicae radicis extractum (extract of angelica root) (1:2.5-3.5) 10.0 ml
extraction solvent - ethanol 30% (v/v)
Matricariae flos extractum (extract of chamomile flower) (1:2-4) 20.0 ml
extraction solvent - ethanol 30% (v/v)
Carvi fructus extractum (extract of caraway fruit) (1:2.5-3.5) 10.0 ml
extraction solvent - ethanol 30% (v/v)
Silybi mariani fructus extractum (extract of milk thistle fruit) (1:2.5-3.5) 10.0 ml
extraction solvent - ethanol 30% (v/v)
Melissae folii extractum (extract of lemon balm leaves) (1:2.5-3.5) 10.0 ml
extraction solvent - ethanol 30% (v/v)
Menthae piperitae folii extractum (extract of peppermint leaves) (1:2.5-3.5) 5.0 ml
extraction solvent - ethanol 30% (v/v)
Chelidonii herbae extractum (extract of greater celandine herb) (1:2.5-3.5) 10.0 ml
extraction solvent - ethanol 30% (v/v)
Liquiritiae radicis extractum (extract of liquorice root) (1:2.5-3.5) 10.0 ml
extraction solvent - ethanol 30% (v/v)
Iberogast contains 29.5–32.6% (v/v) ethanol.

What Iberogast looks like and contents of the pack
Brown glass bottle with a white-green screw cap and a dropper, in a cardboard box.
The pack contains 20 ml of Iberogast.

For further information, please contact the responsible entity or parallel importer.

Responsible entity in Latvia, country of export:
UAB Bayer, Sporto 18, LT-09238, Vilnius, Lithuania

Manufacturer:
Steigerwald Arzneimittelwerk GmbH, Havelstraße 5, D-64295 Darmstadt, Germany

Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing authorisation number in Latvia, country of export: 02-0274
Parallel import authorisation number: 281/25