FLORDIS IBEROGAST 100ML
FLORDIS IBEROGAST 100ML
AUSTRALIAN PRODUCT INFORMATION (PI) IBEROGAST
The medicinal product IBEROGAST, oral liquid, contains the active ingredients Iberis amara whole plant extract liquid, Angelica archangelica root extract liquid, Matricaria recuitita flower extract liquid, Carum carvi fruit extract liquid, Silybum marianum fruit
extract liquid, Melissa offIcianalis leaf extract liquid, Mentha x piperitae leaf extract liquid, Chelidonium majus herb extract liquid and Glycyrrhiza glabra root extract liquid.
Description IBEROGAST oral liquid is a dark brown, clear to lightly cloudy liquid. Iberogast contains the active ingredients listed above, as well as ethanol and purified water..
Pharmacotherapeutic group: IBEROGAST is a herbal medicinal product for gastrointestinal disorders.
IBEROGAST is a fixed combination of 9 liquid extracts and exhibits its effects in the
gastrointestinal tract via a multi-targeted mode of action. In-vitro studies as well as
investigations in animals show a dual method of action at different segments of stomach and intestine. 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 are
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 multi-targeted mode of action.
Pharmacokinetic Properties A fast gastro-intestinal resorption has been proven for many ingredients. From toxicological studies it can be concluded that even at repeated administration of up to six months that the active ingredients in IBEROGAST do not accumulate.
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.
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.
IBEROGAST must not be taken in case of known allergies to the active ingredients (listed under Presentation).
If symptoms persist a doctor should be consulted.
Patients with pre-existing liver disease should consult their doctor prior to commencing treatment with IBEROGAST
Pregnancy and lactation
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).
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.
Effects on ability to drive and use machinery None.
Interactions with other medicinal products
No interactions were known at the time of printing.
In very rare cases, less than one in 10,000, hypersensitivity reactions such as exanthema, pruritus and dyspnea could occur.
Dosage and Administration
Unless otherwise prescribed, IBEROGAST is taken before or with meals in some liquid as following:
Adults and children over 12 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 6 years Give 10 drops 3 times a day (0.5 mL)
Children 3 months to 3 years Give 8 drops 3 times a day (0.4 mL)
Children under 3 months Give 6 drops 3 times a day (0.3 mL)
Duration of use depends on the kind, severity and course of the disease.
Shake the bottle before use.
In acute oral toxicity testing of IBEROGAST in various animal species and during longterm therapeutic experience in humans, no toxic signs of overdose were observed.
IBEROGAST oral liquid contains:
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 offcinalis leaf dry 33.33 mg/mL
Mentha x piperitae (peppermint)leaf ext. liq. (1:2.5-3.5 in 30% E:W) 50 microlitre/mL
EQUIV. Mentha x piperitae 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
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.
Special precautions for storage
Store below 25 C
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.