SIMETICONE IBI OS GTT FL 30ML

SIMETICONE IBI BAMBINI GOCCE ORALI, SOSPENSION

active ingredients

1 ml of suspension contains: Active ingredient: simeticone 66,6 mg. Excipients with known effects This medicine contains 2.4 mg of benzoate sodium per maximum daily dose. For the full list of excipients, see paragraph 6.1.

Excellent

Metilcellulose, xanthan gum, sodium saccharin, currant aroma, benzoate sodium, sodium hydroxide, sorbic acid, purified water.

Therapeutic indications

Syntomatic treatment of gastro-enteric meteorism and infant aerophagia.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

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

Conservation

This medicine does not require any special precaution for conservation.

Warnings

Do not exceed the recommended doses. After a short period of treatment (7 days) without appreciable results consult your doctor. In case of persistence or worsening of symptoms or in case of prolonged constipation, the patient must consult the doctor. Do not use in case of suspected intestinal perforation or ileo. Important information about some excipients This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’. This medicine contains 2.4 mg of benzoate salt per maximum daily dose equivalent to 1 mg/ml. The increase in bilirubinemia following its detachment from albumin can increase the neonatal hetero that can evolve in kernittero (deposits of bilirubin not conjugated in the brain tissue).

Interactions

The contemporary intake of simeticons and laxatives based on mineral oils (paraffin) is not recommended, since the combination of these two products reduces its effectiveness.

Effects

Undesirable effects observed during treatment in clinical trials and integrated with those collected during post-marketing experience are listed in the table below as per the Classification for Systems and Organs (using MedDRA terminology) and as follows: Very common (≥ 1/10); Common(≥ 1/100 until Classification for systems and organs Rare (≥ 1/10.000 up to Very rare ( Gastrointestinal diseases   vomiting, diarrhea, abdominal pain, ileo, nausea Pathologies of skin and subcutaneous tissue   angioedema, rash Immune system pathologies hypersensitivity reactions   Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Overdosing

Pediatric population Symeticons is a chemically inert substance, pharmacologically inactive and not absorbed by the gastrointestinal tract. The symeticons are also eliminated unmodified in the feces. Accidental exposure to the product in children has not detected symptoms in most cases. The symptoms reported were mild to moderate in nature and can be explained with the pre-existing condition.

Pregnancy

There is no adequate data on the use of Simeticone IBI in pregnant women, therefore it should not be used in pregnancy unless a real need and after the assessment of the risk/benefit by the doctor.

Food

It is not known whether symeticons are excreted in breast milk. The excretion of symeticons in breast milk was not studied in animals. The decision whether to continue/interrupt treatment based on symeticons should be taken taking into consideration the benefit of breastfeeding for the newborn and the treatment based on symeticons for women.

Source: Farmadati