SIMECRIN*50CPR MAST 40MG
Symptomatic treatment of gastrointestinal meteorism and aerophagia in adults.
Dosage and method of use
Adults:Simecrin 40 mg Chewable Tablets:4 tablets per day (two at the end of each main meal).Simecrin 80 mg Chewable Tablets:2 tablets per day (one at the end of each main meal).Simecrin 120 mg Chewable Tablets:2 tablets per day (one at the end of each main meal). The tablets must be chewed.Simecrin 80 mg/ml oral emulsion:1-1.5 ml (at the end of each main meal). The prescribed quantity of oral emulsion should be taken with the measuring syringe and dispersed in a glass of water.
Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Generally contraindicated during pregnancy (see section 4.6).
No side effects due to Simecrin have been highlighted.Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. 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.
Do not exceed the recommended dose. After a short period of treatment without appreciable results, consult your doctor. Important information about some excipients The chewable tablets contain lactose: patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. The oral emulsion contains para-hydroxybenzoates which may cause allergic reactions (even delayed). The oral emulsion contains less than 1 mmol (23 mg) sodium per ml, i.e. essentially 'sodium-free'.
Pregnancy and breastfeeding
PregnancyThere are no adequate data on the use of Simecrin in pregnant women, therefore it should not be used during pregnancy unless there is a real need and after a risk/benefit assessment by the doctor.Feeding timeIt is not known whether simethicone is excreted in breast milk. The excretion of simethicone in breast milk has not been studied in animals. The decision whether to continue/discontinue breast-feeding or to continue/discontinue simethicone therapy should be made taking into account the benefit of breastfeeding for the infant and of simethicone therapy for the woman.
Expiration and conservation
Chewable tablets: store the medicine in the original packaging to protect the product from light and humidity.
Interactions with other drugs
There are no known, nor have been reported, interactions with other drugs.
No overdose phenomena have been reported with the use of Simecrin.
Simecrin 40 mg chewable tabletsOne tablet contains:Active principle: simethicone mg 40 Excipient with known effects: 158.8 mg of lactose.Simecrin 80 mg chewable tabletsOne tablet containsActive principle: simethicone mg 80 Excipient with known effects: 317.6 mg of lactose.Simecrin 120 mg chewable tabletsOne tablet contains:Active principle: simethicone 120 mg Excipient with known effects: 476.4 mg of lactose.Simecrin 80 mg/ml oral emulsion1 ml of emulsion contains: Active ingredient: simethicone 80 mg Excipients with known effect: methyl parahydroxy benzoate 0.9 mg, propyl parahydroxy benzoate 0.1 mg and sodium 2.71 mg. For the complete list of excipients see paragraph 6.1
Chewable tabletsMannitol (E421), hydrated colloidal silica, pregelatinized starch, lactose monohydrate, polyvinylpyrrolidone K30, crospovidone, talc, magnesium stearate, mint flavour.Oral emulsion:Citric acid monohydrate, Sodium citrate, Carbomers, Sodium saccharin, Hypromellose, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Tuttifrutti flavour, Purified water.