Active ingredients: Simethicone
SIMECRIN Children 66.6 mg / ml oral drops, emulsion
Why is Simecrin Children used? What is it for?
SIMECRIN contains the active ingredient simethicone, an antimeteoric which works by promoting the elimination of gases that form in the stomach and intestines.
SIMECRIN is used in infants and children to treat symptoms in cases of
- gastro-enteric bloating
- aerophagia.
Talk to your doctor if you don't feel better or if you feel worse after 7 days.
Contraindications When Simecrin Children should not be used
Do not take SIMECRIN
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
- during pregnancy.
Precautions for use What you need to know before you take Simecrin Children
Talk to your doctor or pharmacist before taking SIMECRIN.
Do not exceed the recommended dose.
Interactions Which drugs or foods may change the effect of Simecrin Children
There are no known interactions with other medicines.
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
There are no adequate data on the safety and efficacy of SIMECRIN in pregnancy and breastfeeding, therefore do not take this medicine if you are in these conditions.
Driving and using machines
No known effects.
Dose, Method and Time of Administration How to use Simecrin Children: 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 20 drops 2-4 times a day preferably after meals or as directed by your doctor.
Shake well before use and disperse the drops in a little water.
Overdose What to do if you have taken too much Simecrin Children
If you take more SIMECRIN than you should
There are no known cases of overdose.
If you accidentally take an overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to take SIMECRIN
Skip the forgotten dose and do not take a double dose to make up for a forgotten dose.
Side Effects What are the side effects of Simecrin Children
No undesirable effects have been reported following the use of SIMECRIN.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety. of this medicine.
Expiry and Retention
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 carton after EXP. 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 SIMECRIN contains
- The active ingredient is simethicone. One ml of emulsion contains 66.6 mg of simethicone.
- The other ingredients are citric acid monohydrate, sodium citrate, hypromellose, carboxypolymethylene, saccharin, sodium benzoate, sorbic acid, sodium bicarbonate, raspberry essence, concentrated essence of vanilla, purified water.
Description of the appearance of SIMECRIN and contents of the pack
Fluid emulsion, white in color, with a mixed aroma and flavor of raspberry and vanilla.
SIMECRIN is available in a 30 ml glass bottle with a built-in dropper.
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
SIMECRIN Children - Oral drops, emulsion
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of emulsion contains, active principle: simethicone 66.6 mg
For the full list of excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Oral drops, emulsion.
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. The drops should be dispersed in a little water.
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 interactions with other drugs are known and have not been reported.
04.6 Pregnancy and lactation
Pregnancy
There are no adequate data on the use of Simecrin 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 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 Simecrin were reported.
04.9 Overdose
No overdose phenomena have been reported with the use of Simecrin.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: other drugs for functional intestinal disorders.
ATC code: 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; methyl hydroxypropyl cellulose; carboxypolymethylene; saccharin; sodium benzoate; sorbic acid; sodium bicarbonate; essence of raspberry; 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
No special storage precautions.
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
Crinos SpA - Via Pavia, 6 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
SIMECRIN Children oral drops, emulsion - bottle 30 ml - AIC 034842056
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: 24 October 2007
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of: October 2007
