Mylicon children 66, 6 mg 30 ml oral drops

Mylicon children 66.6 mg 30 ml oral drops is a solution specifically formulated for the symptomatic treatment of gastrointestinal meteorism and aerophagia in infants and children . Thanks to its active ingredient, simethicone , Mylicon acts rapidly by promoting the elimination of intestinal gas and reducing abdominal swelling , abdominal pain , cramps , belching and flatulence that often accompany these conditions in children.

The 30 ml oral solution in drops is easy to administer and well tolerated, making Mylicon children an ideal choice for the symptomatic treatment of disorders related to the accumulation of gas in the intestine. The product is also suitable for newborns and can be used as an over-the-counter medicine to provide rapid relief to the little ones, improving their daily well-being.

Mylicon children 66.6 mg oral drops contains a mixture of excipients selected to ensure maximum safety and tolerability, including sodium benzoate, ethanol, propylene glycol and delicate aromas such as raspberry and vanilla , which make administration more pleasant. Its effectiveness as an antimeteoric is supported by a targeted action that facilitates the dispersion of gas bubbles, helping to reduce abdominal discomfort in children.

Choosing Mylicon children means relying on a safe, practical and specific product for the needs of the little ones, ideal for counteracting the discomforts linked to the accumulation of intestinal gas and promoting the gastrointestinal well-being of infants and children .

ACTIVE INGREDIENTS

Active ingredients contained in Mylicon children 66.6 mg 30 ml oral drops - What is the active ingredient of Mylicon children 66.6 mg 30 ml oral drops?

1 ml of solution contains: Active ingredient : simethicone (activated dimethylpolysiloxane) 66.6 mg. Excipient with known effect : sodium, sodium benzoate, ethanol, propylene glycol. For the full list of excipients, see 6.1

EXCIPIENTS

Composition of Mylicon children 66.6 mg 30 ml oral drops - What does Mylicon children 66.6 mg 30 ml oral drops contain?

Citric acid monohydrate; sodium citrate; methylhydroxypropylcellulose; carboxypolymethylene; saccharin; sodium benzoate; sorbic acid; sodium bicarbonate; raspberry essence; concentrated vanilla essence; purified water.

DIRECTIONS

Therapeutic indications Mylicon children 66.6 mg 30 ml oral drops - Why is Mylicon children 66.6 mg 30 ml oral drops used? What is it used for?

Symptomatic treatment of gastrointestinal meteorism and aerophagia in infants and children.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Mylicon children 66.6 mg 30 ml oral drops - When should Mylicon children 66.6 mg 30 ml oral drops not be used?

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

DOSAGE

Quantity and method of taking Mylicon children 66.6 mg 30 ml oral drops - How to take Mylicon children 66.6 mg 30 ml oral drops?

Dosage Infants and children : 20 drops (= 0.6 ml), 2-4 times a day preferably after meals or otherwise as prescribed by your doctor. Do not exceed the recommended dose. After a short period of treatment (7 days) without appreciable results, consult your doctor. Method of administration Shake well before use. The drops should be dispersed in a little water.

CONSERVATION

Storage Mylicon children 66.6 mg 30 ml oral drops - How is Mylicon children 66.6 mg 30 ml oral drops stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Mylicon children 66.6 mg 30 ml oral drops - About Mylicon children 66.6 mg 30 ml oral drops it is important to know that:

Do not exceed the recommended doses. After a short period of treatment (7 days) without appreciable results, consult your doctor. If symptoms persist, worsen, or if new symptoms appear or in case of prolonged constipation, stop treatment and the patient should consult their doctor. Do not use in case of suspected intestinal perforation or ileus. Important information about some of the excipients: MYLICON contains: • less than 1mmol sodium (23 mg) per dose (20 drops). It can therefore be considered essentially sodium-free; • 0.6 mg sodium benzoate per dose (20 drops) equivalent to 0.17 mg/kg for a 3.5 kg newborn and 0.03 mg/kg for a 20 kg child. The increase in bilirubinemia following its separation from albumin may increase neonatal jaundice which may evolve into kernicterus (deposits of unconjugated bilirubin in the brain tissue); • 0.7025 mg of propylene glycol for each dose (20 drops), equivalent to 1.17 mg/ml. Co-administration with any substrate of alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates. • 0.174 mg of ethanol in each single dose (20 drops) which is equivalent to 0.290 mg/ml. The amount of this medicinal product is equivalent to less than 0.00435 ml of beer or 0.00174 of wine. This medicinal product contains an amount of ethanol such that it does not produce relevant effects.

INTERACTIONS

Interactions Mylicon children 66.6 mg 30 ml oral drops - Which medicines or foods can modify the effect of Mylicon children 66.6 mg 30 ml oral drops?

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

SIDE EFFECTS

Like all medicines, Mylicon children 66.6 mg 30 ml oral drops can cause side effects - What are the side effects of Mylicon children 66.6 mg 30 ml oral drops?

Undesirable effects observed during treatment in clinical studies and integrated with those collected during post-marketing experience are listed in the table below according to the 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
Skin and subcutaneous tissue disorders
Very rare	Angioedema Rash
Immune system disorders
rare	hypersensitivity reactions,

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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.

OVERDOSE

Overdose Mylicon children 66.6 mg 30 ml oral drops - What are the risks of Mylicon children 66.6 mg 30 ml oral drops in case of overdose?

Paediatric population Simethicone is a chemically inert substance, pharmacologically inactive and not absorbed from the gastrointestinal tract. Simethicone is also eliminated unchanged in the faeces. Accidental exposure to the product by children has not revealed symptoms in the majority of cases. The reported symptoms have been mild to moderate in nature and can be explained by the pre-existing condition.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Mylicon children 66.6 mg 30 ml oral drops.

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

DRIVING AND USE OF MACHINERY

Taking Mylicon children 66.6 mg 30 ml oral drops before driving or using machines - Does Mylicon children 66.6 mg 30 ml oral drops affect driving and using machines?

No effects on the ability to drive or use machines have been reported.