Active ingredients: Simethicone
SIMECRIN 40 mg chewable tablets
SIMECRIN 80 mg chewable tablets
SIMECRIN 120 mg chewable tablets
Simecrin package inserts are available for pack sizes: - SIMECRIN 40 mg chewable tablets, SIMECRIN 80 mg chewable tablets, SIMECRIN 120 mg chewable tablets
- SIMECRIN 80 mg / ml Oral emulsion
Indications Why is Simecrin 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 adults 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 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 taking Simecrin
Talk to your doctor or pharmacist before taking SIMECRIN.
Do not exceed the recommended dose.
Children
The tablets are not intended for use in children.
This medicine is available in another form suitable for administration to children: ask your doctor or pharmacist.
Interactions Which drugs or foods may change the effect of Simecrin
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.
Your doctor may advise you to take SIMECRIN only if considered strictly necessary and after careful consideration of the risks and benefits related to its use.
Driving and using machines
No known effects.
SIMECRIN 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.
Dosage and method of use How to use Simecrin: Dosage
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
SIMECRIN 40 mg: 4 tablets per day (2 at the end of each main meal).
SIMECRIN 80 mg: 2 tablets per day (1 at the end of each main meal).
SIMECRIN 120 mg: 2 tablets per day (1 at the end of each main meal).
The tablets must be chewed.
Overdose What to do if you have taken too much Simecrin
If you take more SIMECRIN than you should
There are no known cases of overdose.
If you accidentally take too many tablets, 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 tablet.
Side Effects What are the side effects of Simecrin
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.
Store in the original package to protect the medicine from light and moisture.
Do not throw away 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 tablet contains 40 mg, 80 mg or 120 mg of simethicone.
- The other ingredients are mannitol, colloidal hydrated silica, pregelatinised starch, lactose monohydrate, polyvinylpyrrolidone K 30, crospovidone, talc, magnesium stearate, mint flavor.
Description of the appearance of SIMECRIN and contents of the pack
SIMECRIN 40 mg: round, convex, white chewable tablets with mint flavor, available in packs of 50 tablets.
SIMECRIN 80 mg: white oblong chewable tablets with mint flavor, available in packs of 30 tablets.
SIMECRIN 120 mg: round, flat, white chewable tablets with mint flavor, available in packs of 24 tablets.
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
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
SIMECRIN 40 mg chewable tablets
one tablet contains:
active ingredient: Simethicone 40 mg.
SIMECRIN 80 mg chewable tablets
one tablet contains
active ingredient: Simethicone 80 mg.
SIMECRIN 120 mg chewable tablets
One tablet contains:
active ingredient: Simethicone 120 mg.
SIMECRIN 80 mg / ml oral emulsion
1 ml of emulsion contains:
active ingredient: Simethicone 80 mg.
For excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Chewable tablets; Oral emulsion.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Gastro-enteric meteorism, adult aerophagia.
04.2 Posology and method of administration
SIMECRIN 40 mg chewable tablets:
4 tablets per day (two at the end of each main meal).
SIMECRIN 80 mg chewable tablets:
2 tablets per day (one at the end of each main meal).
SIMECRIN 120 mg chewable tablets:
2 tablets per day (one at the end of each main meal).
SIMECRIN 80 mg / ml oral emulsion:
1-1.5 ml (at the end of each main meal).
04.3 Contraindications
Hypersensitivity to the components of the product.
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 chewable tablets contain lactose: use with caution in lactase insufficiency, galactosemia and glucose / galactose malabsorption syndrome.
The oral suspension contains para-hydroxybenzoates: these can cause allergic reactions, usually of the delayed type.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
Incompatibilities with other drugs are not known, nor have they been reported.
04.6 Pregnancy and lactation
The safety of use of Simethicone in pregnancy has not been ascertained. Therefore the product should be used only in case of need and after an assessment of the risk / benefit.
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 Simethicone were highlighted.
04.9 Overdose
No overdose phenomena have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
A03AX13 Drugs for functional gastrointestinal disorders
Simethicone (activated methylpolysiloxane) is a chemically inert polymer of methylsiloxane. The activation is due to the presence, in the measure, of 4-4.5% of Silicon Oxide which enhances the antifoam power. The chemical-physical property of Simethicone is to lower the surface tension: the gas bubbles in the tract gastrointestinal in the presence of Simethicone converge, forming free gas, which is more 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 rats 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
Toxicological studies conducted in rats, rabbits, dogs and monkeys, treated with different doses of Simethicone for periods of time ranging from three months to two years, did not highlight any pathological changes in the body weight, weight and histological appearance of the various organs, and blood and urine tests. No abnormal effects (fetal and neonatal status, fertility, growth, liver and kidney function, histopathology and organ weights, incidence of tumor numbers) were observed in diet-fed rats containing methylpolysiloxane for three consecutive generations.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Chewable tablets:
mannitol, colloidal hydrated silica, pregelatinised starch, lactose monohydrate, polyvinylpyrrolidone K30, crospovidone, talc, magnesium stearate, mint flavor.
Oral emulsion:
citric acid monohydrate, sodium citrate, carbomer, aodium saccharinate, methylhydroxypropylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, all fruit flavor, 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
Tablets: keep in the original cardboard box to protect the product from humidity and light.
06.5 Nature of the immediate packaging and contents of the package
SIMECRIN "40 mg chewable tablets": box of 50 tablets in blister;
SIMECRIN "80 mg chewable tablets": box of 30 tablets in blister;
SIMECRIN "120 mg chewable tablets": box of 24 tablets in blister;
SIMECRIN 80 mg / ml oral emulsion: glass bottle of 100 ml with dosing syringe.
06.6 Instructions for use and handling
The tablets should be chewed.
The prescribed amount of oral emulsion should be withdrawn with the dosing syringe and dispersed in a glass of water.
07.0 MARKETING AUTHORIZATION HOLDER
CRINOS S.p.A. Via Pavia, 6 - 20136 Milan.
08.0 MARKETING AUTHORIZATION NUMBER
SIMECRIN "40 mg chewable tablets" - 50 tablets AIC n. 034842017
SIMECRIN "80 mg chewable tablets" - 30 tablets AIC n. 034842029
SIMECRIN "120 mg chewable tablets" - 24 tablets AIC n. 034842031
SIMECRIN "80 mg / ml oral emulsion" - Bottle 100 ml AIC n. 034842043
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
10/02/2003
10.0 DATE OF REVISION OF THE TEXT
10/07/2005