Iberogast Advance

Italy
Brand name Iberogast Advance
Form drops, oral, liquid
Prescription type Non-prescription – not available over the counter
ATC code
Registration number 050590
Manufacturer BAYER S.P.A.
Iberogast Advance drops, oral, liquid

Patient Information Leaflet: Information for the User

IBEROGASTADVANCE

Oral drops
Please read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

  • Keep this leaflet. You may need to read it again.
  • If you would like further information or advice, consult your pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.
  • Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet

  1. What IBEROGASTADVANCE is and what it is used for
  2. What you need to know before taking IBEROGASTADVANCE
  3. How to take IBEROGASTADVANCE
  4. Possible side effects
  5. How to store IBEROGASTADVANCE
  6. Contents of the pack and other information

1. What IBEROGASTADVANCE is and what it is used for

IBEROGASTADVANCE is a herbal medicinal product for the symptomatic treatment of functional dyspepsia, a digestive disorder whose main symptoms are stomach pain, burning in the upper abdomen, fullness after eating, and early satiety, but often also loss of appetite, excessive eructation, and heartburn.
IBEROGASTADVANCE is indicated for adults aged 18 years and older.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before taking IBEROGASTADVANCE

Do not take IBEROGASTADVANCE
If you are allergic to any of the active substances (bitter candytuft, chamomile flower, caraway,
lemon balm leaves, peppermint leaves, or licorice root) or to other plants belonging to the Apiaceae or Asteraceae families.

Warnings and precautions
Consult your doctor or pharmacist before taking IBEROGASTADVANCE.
Contact your doctor or pharmacist if symptoms persist after 7 days of treatment or if new symptoms appear, to ensure that no underlying medical conditions are present.

Children and adolescents
The use of IBEROGASTADVANCE in children and adolescents under 18 years of age has not been established due to lack of adequate data. Therefore, use in children and adolescents is not recommended.

Other medicines and IBEROGASTADVANCE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No known pharmacological interactions exist.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Data on the use of IBEROGASTADVANCE during pregnancy are absent or limited. As a precautionary measure, it is preferable to avoid using IBEROGASTADVANCE during pregnancy.
There is insufficient information regarding the excretion of the active substances of IBEROGASTADVANCE or their metabolites in human breast milk. Risks to the breastfed infant cannot be excluded. Seek medical advice.

Driving and using machines
IBEROGASTADVANCE does not affect or affects negligibly the ability to drive vehicles or operate machinery.

IBEROGASTADVANCE contains ethanol
This medicinal product contains 240 mg of alcohol (ethanol) in 20 drops. The amount contained in one dose (20 drops/1 mL) corresponds to less than 7 mL of beer or 3 mL of wine. The small amount of alcohol in this medicine will not produce noticeable effects.

3. How to take IBEROGASTADVANCE

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Adults from 18 years of age:
20 drops, 3 times daily
Patients with impaired renal or hepatic function:
There are insufficient data available to provide specific dosing recommendations in case of reduced renal or hepatic function.
Method of administration
Take in a small amount of liquid, before or during meals.
For oral use.
Shake well before use!
Hold the dropper bottle at a 45° angle when dispensing the drops. Close tightly with the purple cap after use.
Instructions for first use of the dropper

Three diagrams numbered to show how to unscrew the cap of a bottle by rotating it

Remove the cap and discard the white part. Screw the purple cap firmly to insert the dropper. Make sure the dropper is properly inserted.
Duration of treatment
If symptoms persist during treatment with this medicine, consult your doctor or pharmacist after 7 days of treatment (see also warnings in section 2: What you need to know before taking IBEROGASTADVANCE).
Use in children and adolescents
The use of IBEROGASTADVANCE in children and adolescents under 18 years of age has not been established due to lack of adequate data. Therefore, use in children and adolescents is not recommended.
If you take more IBEROGASTADVANCE than you should
Accidental ingestion of a number of drops higher than recommended is unlikely to cause adverse effects. If a significantly higher than recommended dose has been taken, consult your doctor.
If you forget to take IBEROGASTADVANCE
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Allergic reactions may occur, with symptoms such as difficulty breathing, or skin reactions such as itching or rash. Based on the available data, the frequency is unknown (cannot be estimated from the available data).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store IBEROGASTADVANCE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the
bottle after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
This medicine can be used for 8 weeks after first opening the bottle.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. This will help protect the environment.

6. Package contents and other information

What IBEROGASTADVANCE contains
The active substances are:
1 ml contains:
0.15 ml of liquid extract from the whole fresh plant of bitter candytuft (Iberis amara, planta tota recens) (1:1.5–
2.5), extraction solvent ethanol 50% V/V;
0.30 ml of liquid extract from flowers of common chamomile (Matricaria recutita, flos) (1:2–4), extraction solvent
ethanol 30% V/V;
0.20 ml of liquid extract from caraway fruit (Carum carvi, fructus) (1:2.5–3.5), extraction solvent
ethanol 30% V/V;
0.15 ml of liquid extract from lemon balm leaves (Melissa officinalis, folium) (1:2.5–3.5), extraction solvent
ethanol 30% V/V;
0.10 ml of liquid extract from peppermint leaves (Mentha piperita, folium) (1:2.5–3.5), extraction solvent
ethanol 30% V/V;
0.10 ml of liquid extract from liquorice root (Glycyrrhiza species, radix) (1:2.5–3.5), extraction solvent
ethanol 30% V/V.
Total ethanol content: 31% V/V
1 ml = 20 drops

Description of the appearance of IBEROGASTADVANCE and package contents
IBEROGASTADVANCE is a dark brown liquid, from clear to slightly cloudy,
packaged in amber glass bottles equipped with a closure system including a dropper and a screw cap.
Pack sizes: 20 mL, 50 mL or 100 mL
Not all pack sizes may be marketed.

Marketing Authorization Holder
Bayer S.p.A. Viale Certosa 130, 20156 Milan, Italy

Manufacturer
Steigerwald Arzneimittelwerk GmbH
Havelstraße 5
64295 Darmstadt
Germany

This medicinal product is authorized in the European Economic Area countries under the
following names:
Austria: Iberogast SELECT
Belgium: Iberogas
Cyprus: Iberogast N
Czech Republic: Iberogast NEO
Greece: Iberogast N
Italy: Iberogastadvance
Luxembourg: Iberogas
Netherlands: Iberogast Select
Spain: Iberogast Digest