Iberogast
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IBEROGAST® (Iberogast)
Composition:
Active substances: 100 ml of drops contain:
| extract of fresh bitter candytuft (Iberis amara) (extracting solvent: 50% ethanol (v/v)) |
(1:1.5-2.5) |
15 mL; |
| extracts of dried plants (extracting solvent: 30% ethanol (v/v)): |
||
| angelica roots (radix Angelicae) |
(1:2.5-3.5) |
10 mL; |
| chamomile flowers (flores Chamomillae) |
(1:2-4) |
20 mL; |
| caraway fruits (fructus Carvi) |
(1:2.5-3.5) |
10 mL; |
| milk thistle fruits (fructus Silybi marianae) |
(1:2.5-3.5) |
10 mL; |
| leaves of lemon balm (folium Melissae) |
(1:2.5-3.5) |
10 mL; |
| leaves of peppermint (folium Menthae piperitae) |
(1:2.5-3.5) |
5 mL; |
| herb of greater celandine (herba Chelidonii) |
(1:2.5-3.5) |
10 mL; |
| licorice roots (radix Glycyrrhizae) |
(1:2.5-3.5) |
10 mL; |
Excipient: ethanol 31% (v/v);
20 drops in 1 ml.
Pharmaceutical form. Oral drops.
Main physicochemical properties: clear or slightly turbid dark brown liquid.
Pharmacotherapeutic group. Drugs used for functional gastrointestinal disorders. ATC code A03.
Pharmacological properties.
Pharmacodynamics.
The Iberogast® preparation contains extracts of 9 medicinal plants which determine its effects: regulation and normalization of gastrointestinal tract motility. In addition, the preparation has anti-inflammatory, antioxidant, carminative, antibacterial, and cytoprotective properties.
Pharmacokinetics.
Based on toxicological studies using the preparation for up to 6 months, it has been demonstrated that the active substances contained in Iberogast® do not accumulate.
Clinical characteristics.
Indications.
For the treatment of functional gastrointestinal disorders associated with impaired gastric and intestinal motility, namely functional dyspepsia and irritable bowel syndrome, as well as an adjunctive agent for symptomatic treatment of gastritis.
The main symptoms of these disorders include stomach pain, feeling of fullness, meteorism, gastrointestinal spasms, nausea, and heartburn.
Contraindications.
Hypersensitivity to the active components of the drug.
Interaction with other medicinal products and other types of interactions.
No interactions with other medicinal products have been observed.
Special precautions for use.
During storage, turbidity or precipitation may occur, but this does not affect the efficacy of the medicinal product.
This medicinal product contains ethanol 31% (v/v), i.e., up to 240 mg per dose. Therefore, the product should not be used by patients suffering from alcoholism. This should be taken into account for pregnant women and breastfeeding women, children, and patients in high-risk groups, for example, patients with liver disease or epilepsy.
If symptoms do not disappear, or the expected therapeutic effect is not achieved within 7 days, or symptoms worsen, or new symptoms appear, a physician should be consulted.
Medical advice should be sought before administering the product to children under 6 years of age if they experience abdominal pain.
Use during pregnancy or breastfeeding.
During pregnancy or breastfeeding, this medicinal product should be used only after consultation with a physician.
Ability to affect reaction speed when driving or operating machinery.
At recommended doses, the product usually does not affect the ability to drive or operate machinery; however, it should be noted that the product contains ethanol.
Administration and Dosage
Unless otherwise prescribed, take Iberogast® 3 times daily before or during meals with a small amount of liquid (2–3 tablespoons, e.g., room temperature water) in the following doses:
- Adults and children aged 12 years and older: 20 drops;
- Children aged 6 to 12 years: 15 drops;
- Children aged 3 to 6 years: 10 drops.
The duration of treatment is determined individually depending on the severity and course of the disease.
Shake well before use!
Children. Iberogast® should not be used in children under 3 years of age due to insufficient clinical data.
Overdose. Cases of overdose have not been reported to date.
Side effects.
Allergic reactions may very rarely occur, such as skin rashes, itching (including urticaria), dyspnea, or angioedema.
If any adverse reactions occur, discontinue use of the medication and consult a physician.
Shelf life.
Packaging 20 ml – 18 months.
Packaging 50 ml and 100 ml – 2 years.
Do not use the medication after the expiry date stated on the packaging. An opened bottle may be used for up to 8 weeks.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.
Packaging. 20 ml, 50 ml, or 100 ml in a bottle, placed in a cardboard box.
Availability. Over-the-counter (without prescription).
Manufacturer.
Steigerwald Arzneimittelwerk GmbH.
Manufacturer's address.
Havelstrasse 5, 64295 Darmstadt, Germany.