Iberogast

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Iberogast (Iberogast)
oral liquid
Iberogast and Иберогаст are the same brand names of the same medicinal product, written in
Polish and Bulgarian languages.
Please read the entire 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 for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if the patient feels worse after 7 days, consult a doctor.

Table of 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 pack and other information

1. What Iberogast is and what it is used for

Iberogast is a herbal medicinal product used in the treatment of functional gastrointestinal disorders related to gastrointestinal motility, such as functional dyspepsia (indigestion) or irritable bowel syndrome. These disorders are mainly characterized by cramping abdominal and intestinal discomfort, abdominal pain, feeling of fullness, bloating, nausea, and heartburn.
Iberogast relieves the sensation of fullness and bloating, and reduces spasms of the stomach and intestines. It exhibits anti-inflammatory, antiflatulent, 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 diagnosed with 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, medical advice should be sought to exclude other serious conditions.

Iberogast with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
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 concentration of approximately 31% by volume. 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 patients in high-risk groups, including those with liver disease or epilepsy, should consult a doctor before using Iberogast.

Pregnancy and breastfeeding
If the patient is pregnant, 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 used as directed, Iberogast is not expected to 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 a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Instructions for first use of the dropper

Unscrew the white-green cap and discard the white part.
Screw the green cap tightly to secure the dropper in place.
Ensure the dropper is properly inserted 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 a 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 of age: 20 drops three times daily,
• Children aged 6 to 12 years: 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 liquid.
Use of more than the 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. In case of ingestion of significantly larger doses, seek advice from a doctor or pharmacist.
Missed dose of Iberogast
If a dose of Iberogast is missed, 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 effects

Like all medicines, this product may cause adverse effects, although not everyone experiences them.
In very rare cases (less frequent than 1 in 10,000), hypersensitivity reactions may occur, such as skin reactions, itching, or shortness of breath.
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, treatment with Iberogast should be discontinued immediately and medical advice should be sought.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 effects helps to gather more information on the safety of this medicinal product.

5. How to store Iberogast

Store below 25°C.
Keep the medicine out of sight and reach of children.
Shelf life after first opening the immediate packaging: 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. This will help protect the environment.

6. Contents of the pack 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
Dark glass bottle with a dropper and screw cap, in a cardboard box.
The pack contains 20 ml or 50 ml of Iberogast liquid.

For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Bulgaria, country of export:
Bayer Bulgaria EOOD
Blvd. Tsarigradsko Shose No. 115 M, ground floor
1784 Sofia, Bulgaria

Manufacturer:
STEIGERWALD Arzneimittelwerk GmbH, Havelstrasse 5, 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

Bulgaria, country of export marketing authorisation number: 20060714
Parallel import authorisation number: 212/16