SIMECRIN * 30CPR MAST 80MG

SIMECRIN * 30CPR MAST 80MG

Therapeutic indications

Symptomatic treatment of gastrointestinal bloating and adult aerophagia.

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 The prescribed amount of oral emulsion should be withdrawn with the dosing syringe and dispersed in a glass of water.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Generally contraindicated in pregnancy (see section 4.6).

Side effects

No undesirable effects due to Simecrin were reported.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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.

Special warnings

Do not exceed the recommended dose. After a short period of treatment without appreciable results, consult your doctor. Important information about some of the ingredients The chewable tablets contain lactose: patients with 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 can cause allergic reactions (including 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 in pregnancy unless clearly needed and after a benefit / risk assessment by the physician.Feeding timeIt is not known whether simethicone is excreted in human milk. The excretion of simethicone into breast milk has not been studied in animals. The decision whether to continue / discontinue breastfeeding or to continue / discontinue simethicone therapy should be made taking into account the benefit of breastfeeding for the infant and the benefit of simethicone therapy for the woman.

Expiration and retention

Chewable tablets: keep the medicine in the original package to protect the product from light and humidity.

Interactions with other drugs

No interactions with other drugs are known and have not been reported.

Overdose

No overdose phenomena have been reported with the use of Simecrin.

Active principles

Simecrin 40 mg chewable tabletsOne tablet contains:Active principle: simethicone 40 mg Excipient with known effect: 158.8 mg of lactose.Simecrin 80 mg chewable tabletsOne tablet containsActive principle: simethicone 80 mg Excipient with known effect: 317.6 mg of lactose.Simecrin 120 mg chewable tabletsOne tablet contains:Active principle: simethicone 120 mg Excipient with known effect: 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 full list of excipients see section 6.1

Excipients

Chewable tabletsMannitol (E421), Hydrated colloidal silica, Pregelatinised starch, Lactose monohydrate, Polyvinylpyrrolidone K30, Crospovidone, Talc, Magnesium stearate, Mint flavor.Oral emulsion:Citric acid monohydrate, Sodium citrate, Carbomers, Sodium saccharin, Hypromellose, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, All fruit flavor, Purified water.