Simethicone IBI Children Oral Drops 30 ml

Therapeutic indications

Symptomatic treatment of gastro-enteric meteorism and aerophagia in the infant and child.

Dosage

Posology Pediatric population: 15 drops (= 0.6 ml), 2-4 times a day preferably after meals or otherwise according to medical prescription. Method of administration Shake well before use. The drops are dispersed in a little water.

Overdose

No overdose phenomena have been reported with the use of Simethicone IBI.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

No undesirable effects due to Simethicone IBI were highlighted. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Pregnancy There are no adequate data on the use of Simethicone IBI in pregnant women, therefore it should not be used in pregnancy unless clearly needed and after the benefit / risk assessment by the physician. Breastfeeding It is not known whether simethicone is excreted in human milk. The excretion of simethicone into breast milk has not been studied in animals. A decision on whether to continue / discontinue simethicone therapy must be made taking into account the benefit of breastfeeding for the infant and the benefit of simethicone therapy for the woman.

Special warnings

Do not exceed the recommended dose. After a short period of treatment (7 days) without appreciable results, consult your doctor.

Expiry and Retention

No special storage precautions.

Active principles

1 ml of suspension contains: Active ingredient : simethicone 66.6 mg. For the full list of excipients, see section 6.1.

Excipients

Methylcellulose, xanthan gum, sodium saccharin, currant flavor, sodium benzoate, sorbic acid, purified water.