In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219
INDICATIONS
Symptomatic treatment of gastrointestinal meteorism and aerophagia in adults.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the components listed in paragraph 6.1.
WARNINGS AND PRECAUTIONS FOR USE
After a short period of treatment without appreciable results, consult your doctor. In case of persistence, worsening of symptoms, or if new symptoms appear or in case of prolonged constipation, stop treatment and consult your doctor. Do not use in case of suspected intestinal perforation or ileus. Important information about some excipients Mylicongas contains lactose. Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, e.g. galactosemia, or suffering from glucose/galactose malabsorption, should not take this medicine. Mylicongas contains less than 1 mmol (23 mg) of sodium per dose. It can therefore be considered essentially sodium-free.
INTERACTIONS
Taking SIMETICONE and mineral oil (paraffin) laxatives at the same time is not recommended, as the combination of these two products reduces their effectiveness.
SIDE EFFECTS
Side effects observed during treatment in clinical studies and integrated with those collected during post-marketing experience are listed in the table below according to System Organ Class (using MedDRA terminology) and according to the following frequency: Very common ≥ 1/10; Common ≥ 1/100 and < 1/10; Uncommon ≥ 1/1,000 and < 1/100; Rare ≥ 1/10,000 and < 1/1,000; Very rare < 1/10,000.
Gastrointestinal disorders
Very rare | Vomiting, diarrhea, abdominal pain, ileus, nausea
Pathologies of the skin and subcutaneous tissue
Very rare | Angioedema, Rash
Immune system disorders
rare | hypersensitivity reactions
Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.








