Tradename:
Simethicone
Active substance:
Simethicone emulsion 30% 66.68 mg equivalent to 20 mg simethicone
Auxiliary ingredients:
Macrogol 6000, xanthan gum, sodium carmellose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharin, anhydrous citric acid, sodium citrate dihydrate, potassium sorbate, anise flavor and purified water.
Dosage form: Drops for oral use
Pharmachologic effect:
Pharmacodynamic properties
The physiologically active ingredient is a chemically inert, non-systemic gastric defoamer, Gent, which works by altering the elasticity of mucus bubbles in the gastrointestinal tract.
Thus, the gas bubbles collapse or coalesce, and in this form the gas is more easily eliminated through belching or flatulence.
Pharmacokinetics
Simethicone is not absorbed from the gastrointestinal tract
Indication
Means for relieving cramping pain, colic.
Dosage and Administration
For adults and the elderly:
Not shown.
For infants: 20 mg (1 ml) before each feeding.
If necessary, the dose can be increased to 40 mg (2 ml). Simethicone treatment may provide progressive improvement in symptoms over several days.
Side effects
Not
Overdose
In case of intentional or accidental overdose, symptomatic treatment
Drug Interactions
Levothyroxine may bind to simethicone.
Absorption of levothyroxine may be impaired if simethicone is given to infants at the same time as hormonal therapy.
Precautions and Warnings
The parahydrobenzoates used in simethicone may cause delayed-type hypersensitivity reactions.
If symptoms persist, see a doctor.
Storage conditions
Store below 30°C.
Package
Carton box with amber glass bottle.(Type III) containing 30 ml emulsion with cap with low density polypropylene plastic cap, polyethylene foam insert and plastic 3-piece polypropylene dropper cap, polypropylene pipette and thermoplastic elastomer rubber inner bottle , leaflet