Active ingredients: Simethicone
MYLICON Children oral drops, solution
Indications Why is Mylicon used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antimeteorico (favors the elimination of gases that form in the gastrointestinal tract).
THERAPEUTIC INDICATIONS
Symptomatic treatment of gastro-enteric meteorism and of the "aerophagia of the infant and child
Contraindications When Mylicon should not be used
Hypersensitivity to the active substance or to any of the excipients.
Generally contraindicated in pregnancy (see Special warnings)
Precautions for use What you need to know before taking Mylicon
Do not exceed the recommended dose.
After a short period of treatment (7 days) with no appreciable results, consult your doctor.
Interactions Which drugs or foods may change the effect of Mylicon
No interactions with other drugs are known and have not been reported.
Warnings It is important to know that:
Pregnancy.
There are no adequate data on the use of Mylicon in pregnant women, therefore it should not be used in pregnancy unless clearly needed and after a benefit / risk assessment by the physician.
Feeding time.
It is not known whether simethicone is excreted in human milk. The decision on 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.
Dose, Method and Time of Administration How to use Mylicon: Posology
Infants and children: 20 drops (= 0.6 ml), 2-4 times a day preferably after meals or otherwise according to medical prescription.
Shake well before use. The drops should be dispersed in a little water.
Overdose What to do if you have taken too much Mylicon
No overdose phenomena have been reported with the use of Mylicon.
Side Effects What are the side effects of Mylicon
No undesirable effects due to Mylicon were reported
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important that you report any side effects to your doctor or pharmacist.
Expiry and Retention
COMPOSITION
1 ml of solution contains
Active principle: simethicone (activated dimethylpolysiloxane) 66.6 mg
Excipients: Citric acid monohydrate, Sodium citrate, Methylhydroxypropylcellulose, Carboxypolymethylene, Saccharin, Sodium benzoate, Sorbic acid, Sodium bicarbonate, Raspberry essence, Concentrated vanilla essence, Purified water.
PHARMACEUTICAL FORM AND CONTENT
Oral drops, solution; bottle of 30 ml
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
More information about Mylicon can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL
01.0 NAME OF THE MEDICINAL PRODUCT
MYLICON CHILDREN ORAL DROPS SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains
Active principle: simethicone (activated dimethylpolysiloxane) 66.6 mg
For the full list of excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Oral drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of gastro-enteric meteorism and of the "aerophagia of the infant and child.
04.2 Posology and method of administration
Infants and children: 20 drops (= 0.6 ml), 2-4 times a day preferably after meals or otherwise according to medical prescription.
Shake well before use.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
Generally contraindicated in pregnancy (see section 4.6)
04.4 Special warnings and appropriate precautions for use
Do not exceed the recommended dose.
After a short period of treatment (7 days) with no appreciable results, consult your doctor.
04.5 Interactions with other medicinal products and other forms of interaction
No incompatibilities with other drugs are known, nor have they been reported.
04.6 Pregnancy and lactation
Pregnancy.
There are no adequate data on the use of Mylicon in pregnant women, therefore it should not be used in pregnancy unless clearly needed and after a benefit / risk assessment by the physician.
Feeding time.
It 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 on 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 simethicone-based therapy for women.
04.7 Effects on ability to drive and use machines
There are no reported effects on the ability to drive and use of machines.
04.8 Undesirable effects
No undesirable effects due to Mylicon were reported.
04.9 Overdose
No overdose phenomena have been reported with the use of Mylicon.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs for functional intestinal disorders.
ATC A03AX13.
Simethicone (activated methylpolysiloxane) is a chemically inert polymer of methylsiloxane. Its molecular weight ranges from 14,000 to 21,000. Activation is due to the presence, to the extent of 4-4.5% of silica airgel, which enhances its antifoam power. In fact, the chemical-physical property of simethicone is to lower the surface tension; this property means that the gas bubbles present in the gastrointestinal tract converge, forming free gas, which is easily eliminated.
This relieves all those annoying symptoms (pains, cramps, a sense of tension, belching, flatulence) that accompany bloating, the prerogative of many ailments of the gastrointestinal tract.
05.2 Pharmacokinetic properties
Simethicone is not absorbed from the gastrointestinal tract and does not interfere with the absorption of nutrients.
It does not alter the volume and acidity of gastric secretions and chronic toxicity studies in the rat have shown that it does not decrease the absorption of essential metabolites.
Furthermore, the absence of an increase in silicones in the intestinal wall, liver and urine indicates a total lack of absorption.
05.3 Preclinical safety data
Experimental animal data reveal no special hazard for humans based on conventional studies of safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Citric acid monohydrate; Sodium citrate; Methylhydroxypropylcellulose; Carboxypolymethylene; Saccharin; Sodium benzoate; Sorbic acid; Sodium bicarbonate; Raspberry essence; Concentrated essence of vanilla; Purified water
06.2 Incompatibility
There are no known cases of chemical-physical incompatibility with other substances.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
There are no particular storage conditions
06.5 Nature of the immediate packaging and contents of the package
30ml glass dropper bottle
06.6 Instructions for use and handling
See section 4.2 - Posology and method of administration
07.0 MARKETING AUTHORIZATION HOLDER
Johnson & Johnson SpA Via Ardeatina km 23,500 - 00040 Santa Palomba - Pomezia ROME
08.0 MARKETING AUTHORIZATION NUMBER
MYLICON Children, oral drops, solution-bottle 30 ml AIC 020708069
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First Authorization: March 3, 1969
Renewal: May 31, 2005
10.0 DATE OF REVISION OF THE TEXT
May 2008
