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Instructions for medical use of
Iberogast®
Trade name:
Iberogast®
International nonproprietary name
None
Dosage form
drops for internal use, 20 ml, 50 ml and 100 ml
Composition
100 ml of the drops contain
Active substance: extract of fresh whole plants of Clown's mustard
(Iberis amara) 15.0 ml
(1: 1.5 – 2.5) *
Angelica root extract (1: 2.5 – 3.5)** 10.0 ml
Melissa leaf extract (1: 2.5 – 3.5)** 10.0 ml
Сumin fruit extract (1: 2.5 – 3.5)** 10.0 ml
Сelandine herb extract (1: 2.5 – 3.5)** 10.0 ml
Licorice root extract (1: 2.5 – 3.5)** 10.0 ml
Chamomile flower extract (1: 2 – 4)** 20.0 ml
Peppermint leaf extract (1: 2.5 – 3.5)** 5.0 ml
Holy thistle fruit extract (1: 2.5 – 3.5)** 10.0 ml
* - extractant ethyl alcohol 50 %
** - extractant ethyl alcohol 30 %
Note: about 31 % of the ethyl alcohol content
Description
Transparent or slightly cloudy liquid, of dark brown color, with a characteristic smell and bitter taste. During storage, precipitation is possible.
Pharmacotherapeutic group
Drugs for the treatment of functional gastrointestinal disorders.
Code ATX A03
Pharmacological properties
Pharmacokinetics
The drug Iberogast® effect is the result of the combined effect of its components, therefore it is impossible to carry out the kinetic studies.
Pharmacodynamics
Iberogast® causes the modulating effect upon the tone of smooth muscles of the gastrointestinal tract.
First of all, at low tone and reduced gastric motor activity the components of the Clown's mustard (Iberis amara) and Celandine have a tonic, prokinetic effect. At stomach spasms, the garden angelica, holy thistle and licorice cause the antispasmodic effect.
Iberogast® improves concentration of the protecting the mucous membranes of prostaglandins and mucin, reduces concentration of leukotrienes, toxic to the mucous membrane, reduces the production of gastric juice in the accessory cells and it can counteract the symptoms caused by the action of hydrochloric acid, for example, heartburn.
Iberogast® causes an anti-inflammatory effect due to the effect of inhibition of 5-lipoxygenase, carminative, antioxidant and antibacterial effects.
The carried out toxicological studies at the drug use for 6 months demonstrated absence of cumulation of active substances.
Thanks to its various mechanisms and points of application, the drug corresponds to the principle of multi-purpose therapy.
Indications
Dosage and methods of use
To take Iberogast® 3 times a day before or during meals with a small amount of liquid:
- adults and adolescents take per 20 drops,
- children at the age from 6 to 12 years old per 10 drops.
The duration of use depends on the type, severity and process of the disease.
Shake before use!
Adverse reaction
Very rarely!
If any adverse reactions occur, it is necessary to discontinue use of the drug and consult a doctor.
Contraindications
Drug interaction
Now the cases of interaction with other drugs are not described.
Special indications
Precipitation or clouding of the drug Iberogast® do not affect upon its efficiency.
Knowing allergy to the active substances don’t take Iberogast® drops.
Iberogast® drops contain about 31% (by volume) of ethyl alcohol.
Maximal recommended single dose for adults of 20 drops (=1 ml) contains 0.24 g of alcohol.
The drug is not recommended to patients suffering from alcoholism, or patients of a high-risk group, in particular, suffering from liver diseases, epilepsy, having injuries or brain diseases, pregnant, lactating women and children under 6 years old.
The patient should consult a doctor if the symptoms do not disappear, and the expected effect of the drug does not occur.
Taking by diabetic patients
The diabetic patients can take the drug, as a single dose for adults of 20 drops contains less than 0.1 bread units.
Pregnancy and lactation
The patients should not use the drug during pregnancy and during breastfeeding.
Features of the drug effect upon the ability to drive a car or potentially dangerous mechanisms.
It does not effect upon the ability to drive or potentially dangerous mechanisms taking in recommended doses.
Overdosage
Till now, the cases of acute overdose have not been revealed.
Form of output and packing
Per 20 ml, 50 ml or 100 ml of the drug in dark glass bottles with a dosing drip device on the top, with a screw cap and control of the first opening.A self-adhesive label is pasted on the bottle.
Per 1 bottle and the instruction on medical use in the state and Russian languages packed together in a folding cardboard package.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 °C.
Keep out of the reach of children!
Shelf live
2 years
The opened bottles can be used for 8 weeks.
Do not use after the expiration date indicated on the package.
Conditions for drug supply
Without a prescription.
Name and country of the producing organization
STEIGERWALD Arzneimittelwerk GmbH, Hafenstrasse 5
64295 Darmstadt / Germany
Name and country of the packaging company
STEIGERWALD Arzneimittelwerk GmbH, Germany
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Name, address and contact details of the organization in the territory of the Republic of Kazakhstan accepting claims (offers) from consumers concerning the drug quality:
“Bayer KAZ” LLP
Timiryazev Street, 42, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round-the-clock
Tel.: +7 727 258 80 40 (106) – working hours
Fax.: +7 727 244 70 01
e-mail: kz.claims@bayer.com
Address of the organization receiving claims from consumers regarding the quality of products (goods) on the territory of the Republic of Kazakhstan and responsible for post-registration supervision over the drug safety:
“Bayer KAZ” LLP
Timiryazev Street, 42, „Expo City“Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round-the-clock
Tel.: +7 727 258 80 40 (106) – during working hours
Fax.: +7 727 2588 039
e-mail: pv.centralasia@bayer.com