Consumer medicine information

Iberogast

Angelica archangelica root dry; Carum carvi fruit dry; Chelidonium majus herb dry; Glycyrrhiza glabra root dry; Iberis amara whole plant fresh; Matricaria recutita flower dry; Melissa officinalis dry leaf; Mentha x piperita leaf dry; Silybum marianum fruit dry

BRAND INFORMATION

Brand name

Iberogast

Active ingredient

Angelica archangelica root dry; Carum carvi fruit dry; Chelidonium majus herb dry; Glycyrrhiza glabra root dry; Iberis amara whole plant fresh; Matricaria recutita flower dry; Melissa officinalis dry leaf; Mentha x piperita leaf dry; Silybum marianum fruit dry

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Iberogast.

What is in this leaflet ?

This leaflet answers some common questions about IBEROGAST®.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet You may need to read it again.

What IBEROGAST® is used for

IBEROGAST® is a herbal medicine for the relief and treatment of discomfort associated with medically diagnosed Irritable Bowel syndrome (IBS) and Functional Dyspepsia (FD) symptoms such as:

  • stomach pain,
  • abdominal cramps
  • Bloating,
  • Gas,
  • Heartburn,
  • Nausea and indigestion

Advice before using IBEROGAST®

When you must not take it

Do not take/use IBEROGAST® after the expiry date printed on the pack has passed. If you take this medicine after the expiry date it may have no effect at all, or an unexpected effect.

Do not take IBEROGAST® if the packaging shows signs of having been tampered with.

Do not use in children under 3 years. There is insufficient experience with the use of IBEROGAST® in children under 3 years

Before you take IBEROGAST®

Tell your healthcare professional if you are allergic to any of the active ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; rash, itching (pruritus) or hives on the skin.

If you have a pre-existing liver disease consult your doctor prior to using IBEROGAST®.

Greater celandine may harm the liver in some people. Use only under the supervision of a healthcare professional.

Talk to your doctor or pharmacist if you are pregnant or intend to become pregnant before using IBEROGAST.

Talk to your doctor or pharmacist if you are breast-feeding or plan to breast-feed before using IBEROGAST.

For children under 6 years, consult a doctor if there is abdominal pain.

Taking other medicines

There are no known interactions of IBEROGAST® with any other types of medication.

How to use IBEROGAST® properly

IBEROGAST® contains a built-in central dropper in the mouth of the bottle. To dispense the accurate number of drops required remove the white screw cap, turn the bottle upside down, hold it at a 45°angle and give a slight shake. You will notice that the drops will begin to be dispensed

Directions for Use

Shake well before use.

IBEROGAST® is taken in some liquid (e.g. warm water) before or with meals, 3 times daily as follows:

How much to take

Adults and adolescents from 13 years
Take 20 drops (1.0mL) 3 times a day

Children 6 to 12 years
Give 15 drops (0.75mL) 3 times a day

Children 3 to 6 years
Give 10 drops (0.5mL) 3 times a day

If you forget to take it

Skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed. If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If symptoms persist consult your doctor or pharmacist.

Unwanted effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using IBEROGAST®.

Allergic reaction can occur in predisposed patients.

Cases of liver injury have been reported. Stop use and consult your healthcare professional if there are signs or symptoms of liver injury (eg. jaundice, dark urine or uncoloured stool).

If you experience side effects that are not mentioned in this package insert then you should report them to a healthcare professional.

Tell your doctor or pharmacist immediately if you experience any of the formerly described allergic side effects, particularly if they worry you.

Other side effects not listed above may occur in some patients. Tell your healthcare professional if you notice anything that is making you feel unwell when you are taking, or soon after you have finished taking, IBEROGAST®.

Do not be alarmed by the above mentioned side effects. You may not experience any of them.

In case of overdose

If you take too much (overdose)

If you have taken more than you are meant to consult your healthcare professional.

Storage conditions

Keep IBEROGAST® in a cool place where the temperature stays below 25°C.

Do not use if the bottle seal is missing or broken, or if the packaging shows signs of tampering.

Do not use after the expiry date printed on the bottle label and outer packaging. IBEROGAST® should not be used more than eight weeks after initial opening of the bottle.

Keep IBEROGAST® where young children cannot reach it.

Product description

What it looks like

IBEROGAST® is a dark brown, clear to lightly cloudy liquid supplied in brown glass bottles with a built-in central dropper, and a white screw cap.

Ingredients

1ml (20 drops) IBEROGAST Oral Liquid contains:

IBEROGAST® also contains alcohol as ethanol 31%v/v and purified water.

IBEROGAST® is available in the following pack sizes:

20mL, 50 mL and 100mL bottle - AUST R 168967

Sponsor / Distributor

Bayer Australia Ltd.
875 Pacific Highway
Pymble NSW 2073
Ph: 1800 008 757

Date of Preparation
This leaflet was prepared in February 2020

Published by MIMS March 2022

BRAND INFORMATION

Brand name

Iberogast

Active ingredient

Angelica archangelica root dry; Carum carvi fruit dry; Chelidonium majus herb dry; Glycyrrhiza glabra root dry; Iberis amara whole plant fresh; Matricaria recutita flower dry; Melissa officinalis dry leaf; Mentha x piperita leaf dry; Silybum marianum fruit dry

Schedule

Unscheduled

 

1 Name of Medicine

The medicinal product Iberogast oral liquid, contains the active ingredients Iberis amara whole plant extract liquid, Angelica archangelica root extract liquid, Matricaria recutita flower extract liquid, Carum carvi fruit extract liquid, Silybum marianum fruit extract liquid, Melissa officinalis leaf extract liquid, Mentha x piperita leaf extract liquid, Chelidonium majus herb extract liquid and Glycyrrhiza glabra root extract liquid.

2 Qualitative and Quantitative Composition

Active ingredients.

Iberis amara (bitter candytuft) whole plant ext. liq. (1:1.5-2.5 in 50% E:W), 150 microlitre/mL.
Equiv. Iberis amara whole plant fresh 75.00 mg/mL.
Angelica archangelica root ext. liq. (1:2.5-3.5 in 30% E:W), 100 microlitre/mL.
Equiv. Angelica archangelica root dry 33.33 mg/mL.
Matricaria recutita (chamomile) flower ext. liq. (1:2-4 in 30% E:W), 200 microlitre/mL.
Equiv. Matricaria recutita flower dry 66.67 mg/mL.
Carum carvi fruit (caraway) ext. liq. (1:2.5-3.5 in 30% E:W), 100 microlitre/mL.
Equiv. Carum carvi fruit dry 33.33 mg/mL.
Silybum marianum (milk thistle) fruit ext. liq. (1:2.5-3.5 in 30% E:W), 100 microlitre/mL.
Equiv. Silybum marianum fruit dry 33.33 mg/mL.
Melissa officinalis (balm leaf) leaf ext. liq. (1:2.5-3.5 in 30% E:W), 100 microlitre/mL.
Equiv. Melissa officinalis leaf dry 33.33 mg/mL.
Mentha x piperita (peppermint) leaf ext. liq. (1:2.5-3.5 in 30% E:W), 50 microlitre/mL.
Equiv. Mentha x piperita leaf dry 16.67 mg/mL.
Chelidonium majus (celandine) herb ext. liq. (1:2.5-3.5 in 30% E:W), 100 microlitre/mL.
Equiv. Chelidonium majus herb dry 33.33 mg/mL.
Glycyrrhiza glabra (liquorice) root ext. liq. (1:2.5-3.5 in 30% E:W), 100 microlitre/mL.
Equiv. Glycyrrhiza glabra root dry 33.33 mg/mL.
Iberogast also contains ethanol and purified water.

3 Pharmaceutical Form

Oral liquid, solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Iberogast is indicated for the treatment of gastric and abdominal discomfort associated with functional and motility conditioned gastrointestinal disturbances such as functional dyspepsia and irritable bowel syndrome.

4.2 Dose and Method of Administration

Unless otherwise prescribed, Iberogast is taken before or with meals in some liquid as the following.

Adults and adolescents from 13 years.

Take 20 drops 3 times a day (1.0 mL).

Children 6 to 12 years.

Give 15 drops 3 times a day (0.75 mL).

Children 3 to 5 years.

Give 10 drops 3 times a day (0.5 mL).
Duration of use depends on the kind, severity and course of the disease.
Shake the bottle before use.

4.3 Contraindications

Iberogast must not be taken in case of known allergies to the active ingredients (see Section 2 Qualitative and Quantitative Composition).
Due to lack of sufficient experience, Iberogast must not be taken by children below 3 years of age.

4.4 Special Warnings and Precautions for Use

If symptoms persist or if expected improvement from the treatment is not achieved within 7 days, a doctor should be consulted.
Greater celandine may harm the liver in some people. Use only under the supervision of a healthcare professional.
Patients should be advised to immediately discontinue treatment and consult their doctor if signs or symptoms of liver injury occur e.g. jaundice, dark urine or uncoloured stool.
In children below 6 years a physician should always be consulted if there is abdominal pain.
This medicinal product contains 31% v/v ethanol (alcohol), i.e. up to 240 mg per adult dose, equivalent to 6.2 mL beer, 2.6 mL wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Use in hepatic impairment.

Patients with pre-existing liver disease should consult their doctor prior to commencing treatment with Iberogast.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration; Section 4.3 Contraindications.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interactions were known at the time of printing.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Extensive investigations with Iberogast in two animal species were performed assessing acute, subchronic and chronic toxicity at 3 and 6 months, in the areas of reproductive toxicity, fertility, embryonic, pre-and post-natal development and mutagenicity. There is no evidence for any acute or chronic-toxic, reproductive- or embryo-toxic potentials, even when doses of up to 1200 times the recommended daily dose were tested.
There are no or limited amount of data from the use of Iberogast in pregnant women. Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity. As a precaution, it is preferable to avoid the use of Iberogast during pregnancy.
 There is insufficient information on the excretion of Iberogast or its metabolites in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue use of Iberogast taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
From a toxicological perspective no evidence of concern regarding the administration of Iberogast during pregnancy and lactation can be determined from the available data on reproductive toxicity (embryotoxicity, teratogenicity, peri- and postnatal toxicity).

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

According to MedDRA frequency convention, frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). See Table 1.
In these cases, treatment with Iberogast should be discontinued.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

In acute oral toxicity testing of Iberogast in various animal species and during long-term therapeutic experience in humans, no toxic signs of overdose were observed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacotherapeutic group: Iberogast is a herbal medicinal product for gastrointestinal disorders.
ATC code: A03.
Iberogast is a fixed combination of 9 liquid extracts and exhibits its effects in the gastrointestinal tract via a multitargeted mode of action. In vitro studies as well as investigations in animals show a dual method of action at different segments of stomach and intestines. On unstimulated and weakly stimulated stomach and intestine segments, basic tone is increased, primarily by Iberis amara, leading to relief of symptoms such as a feeling of fullness and abdominal distension. The spasmolytic properties of the other drug extracts of Iberogast trigger relaxation in strongly stimulated stomach and intestine segments. Iberogast also decreases the afferent sensitivity to stimuli in the intestine which is caused by dilation and serotonin in vivo. Therefore Iberogast shows effects which help to reduce visceral hypersensitivity due to binding of the different ingredients of Iberogast to specific serotonin, muscarinic and opioid receptors.
Iberogast also increases the concentration of mucosa protective prostaglandins and mucins, decreases the concentration of mucosa damaging leukotrienes and inhibits the production of gastric acid in acid cells.
Iberogast shows anti-inflammatory properties, which can be ascribed to the inhibition of the 5-lipoxygenase, carminative, anti-oxidative and antibacterial actions.
It is therefore apparent that Iberogast exhibits the aforementioned criteria and it exhibits its effect via a multitargeted mode of action.

Clinical trials.

In the areas of functional dyspepsia and irritable bowel syndrome 5 randomized, double blind controlled clinical studies according to ICH-GCP guidelines were conducted.

Functional dyspepsia.

Four studies were conducted in patients with functional dyspepsia, three of them were placebo controlled and one versus the prokinetic cisapride. The main outcome variable in these studies was the validated dyspepsia specific gastrointestinal symptom score (GIS). The GIS comprises 10 dyspepsia symptoms which are assessed as a sumscore. A change in the sumscore during treatment indicates a change of disease intensity and efficacy of therapy. In these studies 243, 60, 186 and 308 patients with functional dyspepsia according to Rome criteria were recruited and after a wash-out period of 7 or 14 days, treated for four weeks with Iberogast, placebo or cisapride. One placebo controlled study (308 patients) was conducted over a treatment period of eight weeks. In the placebo controlled studies, Iberogast showed a significantly superior efficacy vs. placebo for the main outcome criterion. In the study versus cisapride, an equivalent efficacy for Iberogast was determined.

Irritable bowel syndrome.

In a further randomised double blind controlled clinical study 208 patients with irritable bowel syndrome according to Rome criteria were treated, after a 7 day wash-out period for four weeks with Iberogast or placebo. The main outcome parameter was an abdominal symptom profile consisting of eight disease specific symptoms which were analysed as a sumscore. A change of the sumscore indicated an improvement or worsening of the disease. In this trial Iberogast also showed a significantly superior efficacy versus placebo for improving the symptoms of irritable bowel syndrome.

5.2 Pharmacokinetic Properties

A fast gastrointestinal resorption has been proven for many ingredients. From toxicological studies, it can be concluded that even at repeated administration of up to six months, the active ingredients in Iberogast do not accumulate.

5.3 Preclinical Safety Data

Genotoxicity.

See Section 4.6 Fertility, Pregnancy and Lactation.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The shelf life of Iberogast is 24 months.
Should Iberogast show any turbidity or cloudiness, this will have no effect on the efficacy of the preparation.
Do not use Iberogast after the expiry date printed on the container and outer packaging.
Iberogast should not be used more than eight weeks after initial opening of the bottle.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Iberogast, oral liquid, is supplied in an amber glass bottle with a built in dropper and screw cap closure in volumes of 20 mL, 50 mL and 100 mL.

6.6 Special Precautions for Disposal

None.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Iberogast oral liquid is a dark brown, clear to lightly cloudy liquid.

7 Medicine Schedule (Poisons Standard)

Not applicable.

Summary Table of Changes