oral drops, solution
Active substances: Extracts of flower current, watercress, chamomile, cumin, marjoram, lemon balm, peppermint, squash, licorice root.
1. What Iberogast is and what it is used for
Iberogast is herbal medicine for relieving the symptoms of sensitive stomach and intestines (functional dyspepsia and IBS) – such as stomach cramps, pain or burning sensation in the upper abdomen, bloating, and nausea.
You should talk to a doctor if you do not feel better or if you feel worse after 7 days.
2. What you need to know before using Iberogast
Do not use Iberogast
You should only use Iberogast after your doctor has told you that you have functional dyspepsia or IBS (irritable bowel syndrome).
Do not use Iberogast:
- if you are allergic to any of the ingredients of this medicine (listed in section 6) or to basket-flowering plants.
- to children under 2 years.
Warnings and cautions
Talk to your doctor if any of the following occur, even if you know you have functional dyspepsia or IBS:
- You are over 40 years old and it is a long time since you had your last feeling of functional dyspepsia or IBS, or if the symptoms are different this time.
- If you have recently had blood in your stool
- If you have lost your appetite or lost weight.Discontinue treatment with Iberogast immediately and talk to your doctor if you get signs or symptoms of liver damage e.g. jaundice, dark urine or uncoloured stools.
Children
Do not give to children under 2 years due to the ethanol content. Not recommended for children under 12 years due to insufficient data.
Other medicines and Iberogast
The effect of concomitant use of other drugs has not been studied.
In case of contact with a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken this over-the-counter medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
In the absence of adequate data, use during pregnancy or lactation may not be recommended.
The potential effect of the drug on fertility has not been studied.
Driving and using machines
Iberogast has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are authorized to drive motor vehicles or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or other healthcare professional.
Iberogast contains ethanol (alcohol)
Iberogast contains 31 vol% ethanol (alcohol), ie. equivalent to 250 mg per dose, equivalent to 6.2 ml of beer or 2.6 ml of wine per dose. Harmful to people suffering from alcoholism. Attention should be paid to pregnant or lactating women, children, and high-risk groups such as patients with liver disease or epilepsy.
3. How to use Iberogast
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.
Iberogast is taken before or before a meal in a small amount of liquid as follows:
Adults, the elderly, and adolescents over 12 years of age:
20 drops 3 times daily. Shake before use.
Long-term treatment can be done after consultation with a doctor.
Use for children
Children under 2 years:
Should not be given to children under 2 years due to the ethanol content.
Children under 12 years:
Not recommended for children under 12 years due to insufficient data.
Instructions for first use
Screw back the green cap after use.
If you take more Iberogast than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Iberogast
Do not take a double dose to make up for a forgotten dose . Continue dosing next time according to the instructions in the package leaflet or according to the doctor’s instructions
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Discontinue treatment with Iberogast if you experience any of the side effects listed below.
Very rare side effects (may affect up to 1 in 10,000 people):
Hypersensitivity reactions such as skin rash, itchy skin or shortness of breath.
Has been reported (occurs in an unknown number of users):
Liver damage.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Iberogast
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Iberogast can be stored for a maximum of 8 weeks after opening the bottle.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Any flocculation or turbidity has no effect on the effect of Iberogast.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substances per ml are:
0.15 ml liquid extract * of Iberis amara (flower berry) whole plant, corresponding to 60 – 100 mg whole fresh plant of flower berry.
0.10 ml liquid extract ** of Angelica archangelica (kvanne) root, corresponding to 30 – 40 mg dried kvanner root.
0.20 ml liquid extract ** of Matricaria recutita (chamomile) flower, corresponding to 50 – 100 mg dried chamomile flower.
0.10 ml liquid extract ** of Carum carvi (cumin) seeds, corresponding to 30 – 40 mg dried cumin seeds.
0.10 ml liquid extract ** of Silybum marianum (mariatistel) fruit, corresponding to 30 – 40 mg dried fruit of mariatistel.
0.10 ml liquid extract ** of Melissa officinalis (lemon balm) leaves, corresponding to 30 – 40 mg dried leaves of lemon balm.
0.05 ml liquid extract ** of Mentha piperita (peppermint) leaves, corresponding to 10 – 20 mg dried leaves of peppermint.
0.10 ml liquid extract ** of Chelidonium majus (squash) herb, corresponding to 30 – 40 mg dried squash.
0.10 ml liquid extract ** of Glycyrrhiza glabra (licorice root) root, corresponding to 30 – 40 mg dried licorice root.
* Extractant: ethanol 50% v / v
** Extractant: ethanol 30% v / v
Contains 20 drops / ml.
This medicine contains 31 vol% ethanol (alcohol), ie equivalent to 250 mg alcohol per dose (20 drops).
What the medicine looks like and contents of the pack
Brown glass bottle (20 ml, 50 ml and 100 ml) with screw cap and drip dispenser.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bayer AB
Box 606
SE-169 26 Solna
Manufacturer
Steigerwald Arzneimittelwerk GmbH
Havelstrasse 5
D-642 95 Darmstadt
Germany