Iberogast
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Iberogast (Iberogast)
Oral liquid
Iberogast and Иберогаст are different trade names of the same medicinal product written in
Polish and Bulgarian languages.
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 the patient leaflet or as directed by
a doctor or pharmacist.
- Keep this leaflet so that you can 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 after 7 days, or if symptoms worsen, consult your doctor.
Table of contents
- What Iberogast is and what it is used for
- Important information before taking Iberogast
- How to take Iberogast
- Possible side effects
- How to store Iberogast
- 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 (transit), such as functional dyspepsia (indigestion) or irritable bowel syndrome. These disorders are mainly characterized by abdominal and intestinal cramping, abdominal pain, bloating, feeling of fullness, nausea, and heartburn.
Iberogast relieves feelings of fullness and bloating, 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 must be stopped immediately and medical advice 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, contact a doctor to rule out 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 and should not be used in patients with alcohol-related disease.
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 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 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 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 the bottle.
Ensure the dropper is properly inserted.
When dosing, hold the bottle with dropper at a 45° angle. After use, close tightly with the green cap.
For oral use.
Unless otherwise prescribed by a 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 a doctor regarding 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.
Accidental intake of one or two extra doses, 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 a doctor or pharmacist.
Missed dose of Iberogast
If a dose of Iberogast is missed, wait until the next scheduled dose and then take the dose as prescribed by your doctor or as 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 can cause adverse reactions, although not everyone experiences them.
In very rare cases (less frequently than 1 in 10,000) hypersensitivity reactions may occur,
such as skin reactions, itching, shortness of breath.
Frequency unknown: cases of liver injury (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 symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Iberogast
Store below 25°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Shelf-life after first opening of the immediate packaging: 8 weeks.
6. Package contents 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 leaf) (1: 2.5 – 3.5) 10.0 ml
extraction solvent – ethanol 30% (v/v)
Menthae piperitae folii extractum (extract of peppermint leaf) (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 licorice 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
Amber glass bottle with a screw cap and a polyethylene dropper, in a cardboard box.
The pack contains 20 ml or 50 ml of Iberogast.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
Bayer Bulgaria EOOD,
Bld. Tsarigradsko Shose № 115 M, Ground floor,
1784 Sofia
Bulgaria
Manufacturer:
STEIGERWALD Arzneimittelwerk GmbH
Havelstrasse 5
64295 Darmstadt
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Bulgaria Marketing Authorisation Number: 20060714
Parallel Import Authorisation Number: 329/25