Active ingredients: Simethicone
Mylicongas 40 mg chewable tablets
Indications Why is Mylicongas used? What is it for?
This medicine contains simethicone, an active ingredient that works by eliminating gases that form in the stomach or intestines (meteorism).
Mylicongas is used in adults who, due to bloating due, for example, to the tendency to swallow air (aerophagia), have swelling, pain in the abdomen, cramps, belching, flatulence.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment with Mylicongas.
Contraindications When Mylicongas should not be used
Do not take MYLICONGAS
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
Children
Mylicongas is not suitable for pediatric use.
Precautions for use What you need to know before taking Mylicongas
Talk to your doctor if you do not feel better or if you feel worse after treatment.
Interactions Which drugs or foods may change the effect of Mylicongas
No interactions with other drugs are known and have not been reported.
However, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
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 or pharmacist for advice before taking this medicine.
Driving and using machines
Mylicongas does not affect the ability to drive or use machines.
MYLICONGAS contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Mylicongas: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 4 tablets a day. Do not exceed the recommended dose.
Pediatric population
Mylicongas is not suitable for pediatric use.
Method of administration
Take 2 tablets at the end of each main meal.
The tablets must be chewed.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment
Overdose What to do if you have taken too much Mylicongas
If you take more MYLICONGAS than you should
In case of accidental ingestion of an excessive dose of the medicine, consult your doctor or pharmacist.
If you forget to take MYLICONGAS
Do not take a double dose to make up for a forgotten dose. Just take your next dose as normal.
Side Effects What are the side effects of Mylicongas
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you notice the following side effects while using MYLICONGAS:
- He retched;
- rashes on the skin;
- swelling of the face, eyes, lips, tongue, throat with difficulty in breathing (angioedema).
Such effects occur very rarely.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili.” By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep the medicine in the original package to protect the product from light and humidity.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What MYLICONGAS contains
The active ingredient is: simethicone.
Each tablet contains 40 mg of simethicone.
The other ingredients are: saccharin; alginic acid; lactose; sodium bicarbonate; povidone; hydrated calcium silicate; magnesium stearate.
Description of what MYLICONGAS looks like and contents of the pack
Mylicongas is a chewable tablet medicine, available in packs of 24 or 50 tablets contained in blisters.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
MYLICONGAS 40 MG CHEWABLE TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active principle: simethicone (activated dimethylpolysiloxane) 40 mg
For the full list of excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Chewable tablets
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of gastrointestinal bloating and adult aerophagia.
04.2 Posology and method of administration
Adults: 4 tablets per day (2 at the end of each main meal).
The tablets must be chewed.
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 without appreciable results, consult your doctor. The medicinal product contains lactose and is therefore not suitable for individuals with lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome.
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 MYLICONGAS in pregnant women, therefore it should not be used in pregnancy unless there is a real need 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 MYLICONGAS were highlighted.
04.9 Overdose
No overdose phenomena have been reported with the use of MYLICONGAS.
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
Saccharin; Alginic acid; Lactose; Sodium bicarbonate; Povidone; Hydrated calcium silicate; Magnesium stearate
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
Keep the medicine in the original package to protect the product from light and humidity
06.5 Nature of the immediate packaging and contents of the package
Box of 24 tablets 40 mg in blister
Box of 50 tablets 40 mg in blister
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
MYLICONGAS 40 mg chewable tablets-24 tablets AIC 038140024
MYLICONGAS 40 mg chewable tablets-50 tablets AIC 038140012
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
April 20, 1966
May 31, 2005
10.0 DATE OF REVISION OF THE TEXT
May 2008
