Iberogast balance
Poland
Table of Contents
Package leaflet: Information for the patient
Iberogast Balance
oral drops, solution
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 7 days, or if your condition worsens, contact your doctor.
Contents of the leaflet
- What Iberogast Balance is and what it is used for
- Important information before taking Iberogast Balance
- How to take Iberogast Balance
- Possible side effects
- How to store Iberogast Balance
- Contents of the pack and other information
1. What Iberogast Balance is and what it is used for
Iberogast Balance is a herbal medicinal product used in the treatment of functional dyspepsia
(indigestion), with main symptoms such as: abdominal pain, epigastric burning, postprandial fullness, and early satiety, but often also loss of appetite, excessive belching, and heartburn.
Iberogast Balance is indicated for use in adults aged 18 years and over.
If there is no improvement after 7 days, or if your condition worsens, contact your doctor.
2. Important information before using Iberogast Balance
When not to use Iberogast Balance
If the patient is allergic to any of the active substances (bitter candytuft herb, chamomile flowers, caraway fruit, lemon balm leaf, peppermint leaf, or liquorice root) or to other plants from the Apiaceae or Asteraceae families.
Warnings and precautions
Before starting treatment with Iberogast Balance, consult a doctor or pharmacist.
If there is no improvement after 7 days, if symptoms worsen, or if new symptoms occur, consult a doctor to rule out other diseases.
Children and adolescents
The use of Iberogast Balance in children and adolescents under 18 years of age has not been established due to lack of appropriate data. Therefore, the use of this product is not recommended in children and adolescents.
Iberogast Balance and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been reported.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Data on the use of Iberogast Balance in pregnant women are unavailable or limited. As a precautionary measure, it is recommended to avoid using Iberogast Balance during pregnancy.
There are insufficient data on whether the active substances of Iberogast Balance or their metabolites pass into human milk. A risk to the breastfed infant cannot be excluded. Consult a doctor.
Driving and operating machinery
Iberogast Balance has no effect or has a negligible effect on the ability to drive and operate machinery.
Iberogast Balance contains ethanol
This medicine contains 240 mg of alcohol (ethanol) in 20 drops. The amount of alcohol in a single dose (20 drops/1 mL) of this medicine corresponds to less than 7 mL of beer or 3 mL of wine. The small amount of alcohol contained in this medicine does not cause noticeable effects.
3. How to use Iberogast Balance
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults aged 18 years and over:
20 drops, 3 times daily.
Patients with impaired kidney or liver function:
Insufficient data are available regarding specific dosage recommendations in patients with impaired kidney or liver function.
Method of administration
The medicine should be taken in a small amount of liquid before or during meals.
For oral use only.
Shake well before use!
When dosing, hold the dropper bottle at a 45° angle. After use, close the cap tightly.
Instructions for first use of the dropper
Unscrew the cap and discard the white part. Insert the purple part into the neck of the bottle. Screw the cap tightly to ensure the dropper is securely in place.
Duration of treatment
If symptoms persist during treatment with this medicinal product, consult your doctor or pharmacist (also refer to the warnings in section 2, Important information before taking Iberogast Balance).
Use in children and adolescents
The use of Iberogast Balance in children and adolescents under 18 years of age has not been established due to lack of appropriate data. Therefore, use in children and adolescents is not recommended.
Accidental overdose of Iberogast Balance
Accidentally taking more drops than recommended should not cause adverse effects. However, if a significantly higher than recommended dose is taken, consult a doctor.
Missed dose of Iberogast Balance
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Allergic reactions may occur, with symptoms such as breathing difficulties or skin reactions,
e.g. itching or rash. Based on available data, the frequency of occurrence is unknown
(cannot be estimated from the available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl . Adverse reactions can also be reported to the responsible entity. By reporting adverse reactions, additional information on the safety of the medicine use can be collected.
5. How to store Iberogast Balance
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Expiry date after first opening the bottle: 8 weeks.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Iberogast Balance contains
Active substances:
1 mL contains:
0.15 mL liquid extract from bitter candytuft herb ( Iberis amara L., herba ) (1:1.5-2.5),
extraction solvent: ethanol 50% (V/V)
0.30 mL liquid extract from chamomile flowers ( Matricaria recutita L., flos ) (1:2-4),
extraction solvent: ethanol 30% (V/V)
0.20 mL liquid extract from caraway fruit ( Carum carvi L., fructus ) (1:2.5-3.5),
extraction solvent: ethanol 30% (V/V)
0.15 mL liquid extract from lemon balm leaves ( Melissa officinalis L., folium ) (1:2.5-3.5),
extraction solvent: ethanol 30% (V/V)
0.10 mL liquid extract from peppermint leaves ( Mentha x piperita L., folium ) (1:2.5-3.5),
extraction solvent: ethanol 30% (V/V)
0.10 mL liquid extract from licorice root ( Glycyrrhiza glabra L. and/or G. inflata Bat.
and/or G. uralensis Fisch, radix ) (1:2.5-3.5),
extraction solvent: ethanol 30% (V/V)
Total ethanol content: 31% (V/V).
1 mL = 20 drops
What Iberogast Balance looks like and contents of the pack
Iberogast Balance is a dark brown, clear or slightly cloudy liquid, packed in amber glass bottles with a closure system containing a dropper insert and a screw cap.
Pack sizes: 20 mL, 50 mL or 100 mL.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel.: +48 22 572 35 00
Manufacturer
Steigerwald Arzneimittelwerk GmbH
Havelstraße 5
64295 Darmstadt
Germany
This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Iberogast BALANCE Tropfen zum Einnehmen
Bulgaria: Iberogast Balance oral drops, liquid
Croatia: Iberohexa oralne kapi, tekućina
Estonia: Iberoherb
Hungary: Iberogast Select belsőleges oldatos cseppek
Latvia: Iplaceh
Lithuania: Iberoherb geriamasis skystis
Norway: Iberoherb
Poland: Iberogast Balance
Romania: Iberogast Balance picături orale, soluție
Slovakia: Iberogast Neo
Slovenia: Iberohexa peroralne kapljice, raztopina
Sweden: Iberoherb