Iberogast oral drops in solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Iberogast
Oral drops solution
Ethanol liquid extracts of white horehound, angelica roots, chamomile flowers, caraway fruits, milk thistle fruits, lemon balm leaves, peppermint leaves, greater celandine, licorice root.
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for use provided in this 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 more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days of treatment.
Contents of the leaflet
- What Iberogast is and what it is used for
- What you need to know before taking Iberogast
- How to take Iberogast
- Possible adverse 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 containing ethanolic liquid extracts of white henbane, angelica root, chamomile flowers, caraway fruits, milk thistle fruits, lemon balm leaves, peppermint leaves, greater celandine, and liquorice root.
This medicine is indicated for the treatment of gastrointestinal disorders such as dyspepsia (digestive disorder) and gastritis (inflammation of the stomach), as well as for the relief of associated symptoms, including stomach pain, abdominal bloating, flatulence, gastrointestinal colic, nausea, and heartburn.
Iberogast is indicated for use in adults and adolescents over 12 years of age.
Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.
2. What you need to know before starting to take Iberogast
Do not take Iberogast
If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
If you currently have or have previously had liver disease, or if you are taking medications that list liver damage as a possible side effect in the package leaflet. If in doubt, consult your doctor or pharmacist.
Warnings and precautions
Consult your doctor, pharmacist, or nurse if symptoms persist or if you do not achieve the expected results despite treatment.
Be alert for signs and symptoms that may indicate your liver is not functioning properly.
If you notice yellowing of the skin or eyes, dark urine, pale stools, or pain in the upper abdomen, stop treatment with Iberogast immediately and consult your doctor. These may be symptoms of liver damage.
Children and adolescents
This medicine should not be used in children under 12 years of age, as there is insufficient clinical information available.
If your symptoms do not improve within 7 days or worsen, consult your doctor so that other serious conditions can be ruled out.
Other medicines and Iberogast
No interactions with other medicines are currently known.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Iberogast with food and drinks
No interactions with food and drinks are known.
Pregnancy, breastfeeding and fertility
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.
No studies have been conducted to establish the safety of this medicine during pregnancy or breastfeeding; therefore, it should not be administered under these circumstances.
Driving and using machines
Iberogast contains ethanol (alcohol). At the recommended doses, the amount of alcohol ingested is unlikely to affect your ability to drive or operate machinery. However, it may reduce reaction capacity; therefore, it is not advisable to drive or operate machinery requiring special attention until you are certain that your ability to perform such tasks is not impaired.
Important information about certain ingredients in Iberogast
Iberogast contains 31% (V/V) ethanol (alcohol), corresponding to 240 mg of ethanol in 20 drops (per dose unit), equivalent to 6.2 ml of beer or 2.6 ml of wine. This medicine may be harmful for individuals suffering from alcoholism. The alcohol content should be taken into account in pregnant women or those who are breastfeeding, children, and high-risk populations such as patients with liver disease or epilepsy.
Iberogast contains less than 0.1 IU per 20 drops (dose unit).
3. How to take Iberogast
Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
The recommended normal dose is:
Adults and adolescents over 12 years of age: take 20 drops of Iberogast, 3 times daily before or during meals, mixed with a small amount of liquid. The bottle should be tilted during dispensing (at a 45º angle).
If symptoms persist or worsen after 7 days of treatment, consult your doctor.
After 2 months of using the medicine, consult your doctor regarding the possibility of continuing treatment. The duration of treatment depends on the type, severity, and progression of the disease.
Remember to shake the medicine well before use.
Use in children and adolescents:
Administration of this medicine is not recommended for children under 12 years of age.
If you take more Iberogast than you should
There have been no reported cases of acute overdose to date. However, the alcohol content present in the product should be taken into consideration.
In case of overdose, the adverse effects described could be intensified. In the event of accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount ingested.
If you forget to take Iberogast
If you forget to take a dose of Iberogast, take the next dose as described in the instructions in this leaflet or according to the dosage prescribed by your doctor. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Iberogast may cause adverse effects, although not everyone experiences them.
Very rare (may affect up to 1 in 10,000 people): hypersensitivity reactions such as skin rashes, itching, or difficulty breathing.
Frequency not known (cannot be estimated from available data): liver damage (elevated liver values, drug-related jaundice, hepatitis, and liver failure) have been reported; if you notice symptoms such as yellowing of the skin or eyes, dark urine, or pale stools, you must stop treatment with Iberogast immediately and consult your doctor.
If you experience a reaction to the medicine, you should discontinue administration and seek immediate medical advice. Your doctor will be able to assess the severity of the reaction and determine any additional necessary measures.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not described in this leaflet.
Reporting of adverse effects:
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can 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
Keep this medicine out of the sight and reach of children.
Do not store above 25 ºC.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Use Iberogast within 8 weeks of first opening the container.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Iberogast
Each ml of oral drops (equivalent to 20 drops) contains:
Ethanol liquid extract (50% (V/V)):
0.15 ml of fresh herbs of Iberis amara L., white candyflower (1:1.5–2.5);
Ethanol liquid extracts (30% (V/V)):
0.2 ml of flowers of Matricaria recutita L., chamomile (1:2–4);
0.1 ml of root of Angelica archangelica L., angelica (1:2.5–3.5);
0.1 ml of fruit of Carum carvi L., caraway (1:2.5–3.5);
0.1 ml of Chelidonium majus L., greater celandine (1:2.5–3.5);
0.1 ml of root of Glycyrrhiza glabra L., liquorice (1:2.5–3.5);
0.1 ml of leaves of Melissa officinalis L., lemon balm (1:2.5–3.5);
0.1 ml of fruit of Silybum marianum L. Gaertner, milk thistle (1:2.5–3.5); and
0.05 ml of leaves of Mentha piperita L., peppermint (1:2.5–3.5).
Other components (excipient(s)):
The medicine contains 31% (V/V) ethanol.
Appearance of the product and contents of the container
Dark brown liquid, transparent or slightly turbid, with a characteristic odour and bitter taste.
Due to the nature of the product, Iberogast may occasionally show precipitates or turbidity. This does not affect the efficacy of the preparation.
The medicine is supplied in an amber glass bottle with dropper and screw cap. It is available in three pack sizes: 20 ml, 50 ml and 100 ml.
Marketing Authorization Holder:
Bayer Hispania, S.L.
Av. Baix Llobregat, 3-5
08970 Sant Joan Despí (Barcelona)
Manufacturer:
Steigerwald Arzneimittelwerk GmbH
Havelstrasse 5
Darmstadt D-64295
Germany
Date of the most recent revision of this leaflet: April 2019
"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/"
INSTRUCTIONS FOR USE OF THE DROPPER
