Iberogast Elemental oral drops in solution
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Iberogast Elemental is and what it is used for
- 2. What you need to know before starting to take Iberogast Elemental
- 3. How to take Iberogast Elemental
- 4. Possible adverse effects
- 5. Storage of Iberogast Elemental
- 6. Contents of the container and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Iberogast Elemental oral drops solution
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any kind of adverse reaction, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
- You should consult a doctor if you do not improve or if your condition worsens after 7 days.
Leaflet Contents
- What Iberogast Elemental is and what it is used for
- What you need to know before taking Iberogast Elemental
- How to take Iberogast Elemental
- Possible side effects
- How to store Iberogast Elemental
- Contents of the pack and other information
1. What Iberogast Elemental is and what it is used for
Iberogast Elemental is a herbal medicinal product for the symptomatic treatment of functional dyspepsia characterized by main symptoms such as stomach pain, burning sensation in the upper abdomen, postprandial fullness, and early satiety, but often also loss of appetite, excessive belching, and gastric acidity.
Iberogast Elemental is indicated for adults aged 18 years and over.
You should consult a doctor if you do not improve or if your symptoms worsen after 7 days.
2. What you need to know before starting to take Iberogast Elemental
Do not take Iberogast Elemental
If you are allergic to the active substances (Iberis amara root, chamomile flower, caraway fruit,
lemon balm leaf, peppermint leaf, or liquorice root) or to other plants from the Apiaceae or Asteraceae families.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Iberogast Elemental.
Consult your doctor or pharmacist if your symptoms persist after 7 days or if new symptoms appear, to ensure that there is no underlying disease.
Children and adolescents
The use of Iberogast Elemental in children and adolescents under 18 years of age has not been established due to insufficient data. Therefore, its use is not recommended in children and adolescents.
Other medicines and Iberogast Elemental
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There are no data or data are limited regarding the use of Iberogast Elemental in pregnant women. As a precautionary measure, it is preferable to avoid using Iberogast Elemental during pregnancy.
There is insufficient information on the excretion of the active substances of Iberogast Elemental or their metabolites in breast milk. Risk to breastfed infants cannot be excluded. Consult your doctor.
Driving and using machines
The influence of Iberogast Elemental on the ability to drive and use machines is none or negligible.
Iberogast Elemental contains ethanol
This medicine contains 240 mg of alcohol (ethanol) in 20 drops. The amount in a dose (20 drops/1 ml) of this medicine is equivalent to less than 7 ml of beer or 3 ml of wine. The small amount of alcohol present in this medicine will have no perceptible effect.
3. How to take Iberogast Elemental
Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Recommended dose
Adults from 18 years of age:
20 drops 3 times a day
Patients with reduced renal or hepatic function:
Insufficient data are available to recommend specific doses in case of reduced renal or hepatic function.
Method of administration
Take with some liquid before or during meals.
For oral use.
Shake well before use.
When dispensing, tilt the dropper bottle at a 45° angle. After use, close tightly with the purple cap.
Instructions for first use of the dropper
Remove the cap and discard the white part. | Screw the purple cap by hand to insert the dropper. | Ensure the dropper is properly inserted. |
Duration of use
If symptoms persist during use of the medication, consult a doctor or pharmacist after 7 days (see also the warnings in section 2: What you need to know before taking Iberogast Elemental).
Use in children and adolescents
The use of Iberogast Elemental in children and adolescents under 18 years of age has not been established due to lack of sufficient data. Therefore, its use is not recommended in children and adolescents.
If you take more Iberogast Elemental than you should
If you have accidentally taken more drops than recommended, this should not have a negative effect. However, if you have taken a significantly higher dose than recommended, consult your doctor.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.
If you forget to take Iberogast Elemental
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions may occur, with symptoms such as difficulty breathing or skin reactions such as itching or rash. According to the available data, the frequency is unknown (cannot be estimated from the available data).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet.
You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Iberogast Elemental
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
This medicine can be used for 8 weeks after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Iberogast Elemental
The active substances are:
1 ml contains:
0.15 ml of liquid extract of white candyflower, whole plant (Iberis amara L., planta tota recens) (1:1.5-2.5), extraction solvent ethanol 50% V/V
0.30 ml of liquid extract of chamomile flowers (Matricaria recutita L., flos) (1:2-4), extraction solvent ethanol 30% V/V
0.20 ml of liquid extract of caraway fruit (Carum carvi L., fructus) (1:2.5-3.5), extraction solvent ethanol 30% V/V
0.15 ml of liquid extract of lemon balm leaves (Melissa officinalis L., folium) (1:2.5-3.5), extraction solvent ethanol 30% V/V
0.10 ml of liquid extract of peppermint leaves (Mentha piperita L., folium) (1:2.5-3.5), extraction solvent ethanol 30% V/V
0.10 ml of liquid extract of licorice root (species of Glycyrrhiza, radix) (1:2.5-3.5), extraction solvent ethanol 30% V/V
Total ethanol content: 31% V/V
1 ml = 20 drops
Presentation of the product and contents of the container
Iberogast Elemental is a dark brown liquid, clear to slightly turbid, packaged in amber glass bottles with a closure system including a dropper and a screw cap.
Pack sizes: 20 ml, 50 ml or 100 ml.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Bayer Hispania, S.L.
Av. Baix Llobregat, 3-5
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturer
Steigerwald Arzneimittelwerk GmbH
Havelstraße 5
64295 Darmstadt
Germany
This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
Austria: Iberogast SELECT Tropfen zum Einnehmen
Belgium: Iberogas druppels voor oraal gebruik, vloeistof / liquide oral en gouttes / Tropfen zum Einnehmen, Flüssigkeit
Cyprus: Iberogast N
Czech Republic: Iberogast NEO
Greece: Iberogast N
Italy: IBEROGASTADVANCE
Luxembourg: Iberogas druppels voor oraal gebruik, vloeistof / liquide oral en gouttes / Tropfen zum Einnehmen, Flüssigkeit
Netherlands: Iberogast Select
Spain: Iberogast Elemental oral drops in solution
Date of the most recent review of this leaflet: {April 2023}.
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).