Phytotherapeutic medicinal product suitable for the treatment of functional dyspepsia in adults.
Indications
Iberogastadvance is a phytotherapeutic medicinal product for the symptomatic treatment of functional dyspepsia, the main symptoms of which are epigastric pain, epigastric heartburn, postprandial fullness and early satiety, but often also loss of appetite, excessive belching and heartburn. Iberogastadvance is indicated for adults aged 18 years and over.
Composition
Active substances
1 ml contains: 0.15 ml of liquid extract of bitter iberis (Iberis amara L., planta tota recens) (1:1.5-2.5), extraction solvent ethanol 50% V/V; 0.30 ml of liquid extract of common chamomile flower (Matricaria recutita L., flos) (1:2-4), extraction solvent ethanol 30% V/V; 0.20 ml of liquid extract of cumin fruit (Carum carvi L., fructus) (1:2.5-3.5), extraction solvent ethanol 30% V/V; 0.15 ml of liquid extract of lemon balm leaves (Melissa officinalis L., folium) (1:2.5-3.5), extraction solvent ethanol 30% V/V; 0.10 ml of liquid extract of peppermint leaves (Mentha x piperita L., folium) (1:2.5-3.5), extraction solvent ethanol 30% V/V; 0.10 ml of liquid extract of liquorice root (Glycyrrhiza glabra L., and/or G. inflata Bat. and/or G. uralensi Fisch, radix) (1:2.5-3.5), extraction solvent ethanol 30% V/V. 1 ml = 20 drops. Total ethanol content approximately 31% V/V.
Excipients
None.
Directions for use and Dosage
Dosage
Adults aged 18 years and over: 20 drops (1 mL) 3 times a day. Paediatric population: The safety and efficacy of Iberogastadvance in children and adolescents under 18 years of age have not been established. Renal or hepatic impairment: There are insufficient data to make specific dosage recommendations in patients with impaired renal/hepatic function. Method of administration: Take with a little liquid before or during meals. Oral use. Shake before use. Hold the dropper bottle at a 45-degree angle during dispensing. Close tightly with the purple cap after use. Duration of treatment: If symptoms persist during treatment with the medicine, consult a doctor or pharmacist after 7 days of treatment.
Warnings
Patients should be advised to consult a doctor if symptoms persist, if new symptoms develop, or if the expected success of the administration is not achieved within 7 days to ensure there are no underlying conditions. Paediatric population: The safety and efficacy of Iberogastadvance in children and adolescents under 18 years of age have not been established. Therefore, use in children and adolescents is not recommended. This medicine contains 240 mg of alcohol (ethanol) in 20 drops. The amount contained in one dose (20 drops/1 ml) of this medicine is equivalent to less than 7 ml of beer or 3 ml of wine. The small amount of alcohol contained in this medicine will not produce noticeable effects.
Contraindications
Hypersensitivity to the active substances or to other plants of the Apiaceae or Asteraceae family.
Undesirable effects
According to the MedDRA frequency convention, frequencies are defined as very common (>=1/10), common (between >=1/100 and <1/10), uncommon (between >=1/1,000 and <1/100), rare (between >=1/10,000 and <1/1,000), very rare (<1/10,000) and not known (frequency cannot be estimated from the available data). Immune system disorders. Not known: allergic reactions (e.g., dyspnoea or skin reactions such as itching or rash). Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorization of the herbal medicinal product is important. It allows continued monitoring of the benefit/risk balance of the herbal medicinal product.
Pregnancy and breastfeeding
Pregnancy:There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of Iberogastadvance in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Iberogastadvance during pregnancy.
Breastfeeding: There is insufficient information on the excretion of the active substances of Iberogastadvance or its metabolites in human breast milk. A risk to the infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy with Iberogastadvance taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: There are no data available on the effects of Iberogastadvance on fertility. No effects on fertility have been observed in animal experiments.
Storage
Do not store above 25 degrees C.
Format
50 ml Drops
Product Code:FRCM205408
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