Instructions for Espumizan baby oral drops 100mg/ml 30ml
Composition
active ingredient: 1 ml of oral drops, emulsion contains simethicone 100 mg;
Excipients: macrogol stearate, glycerol monostearate, carbomers, banana flavoring, acesulfame potassium, non-crystallizing liquid sorbitol (E 420), sodium chloride, sodium citrate, sodium hydroxide, sorbic acid, purified water.
Dosage form
Oral drops, emulsion.
Main physicochemical properties: low-viscosity emulsion of milky-white color, with a fruity banana odor.
Pharmacotherapeutic group
Drugs affecting the digestive tract and metabolism. Drugs used in case of functional disorders of the digestive tract.
ATX code A03A X13.
Pharmacological properties
Pharmacodynamics
Simethicone is a non-toxic, silicon-based surfactant that is an antifoam. It changes the surface tension of gas bubbles formed in the stomach contents and intestinal mucus, causing them to collapse. The released gases are absorbed by the intestinal wall or removed during intestinal peristalsis.
Pharmacokinetics
Simethicone acts exclusively on the surface of gas bubbles and is not absorbed by the mucous membrane of the digestive tract. Simethicone is not absorbed when administered orally and is excreted unchanged by the intestines.
Indication
- Symptomatic treatment of gastrointestinal complaints associated with gas formation, e.g. flatulence, including in the postoperative period; colic in infants;
- As an aid in conducting diagnostic examinations of the abdominal organs (radiography, ultrasound) and preparation for gastroduodenoscopy.
- As an antifoam for intoxications with surfactants (washing powders or detergents).
Contraindication
Hypersensitivity to simethicone or other components of the drug, complete intestinal obstruction.
Interaction with other medicinal products and other types of interactions
Unknown so far.
Application features
The drug should be used with caution in patients with obstructive diseases of the gastrointestinal tract.
At the first appearance, as well as in case of repeated or persistent complaints, a clinical examination should be performed. Due to the possibility of swallowing the measuring cup by children, it should be kept out of the reach of children. The medicine should also be kept out of the reach of children.
The drug contains 199.17 mg of sorbitol in 1 ml of drops, therefore it should not be prescribed to patients with a rare hereditary form of fructose intolerance.
Use during pregnancy or breastfeeding
There are no reservations.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no reservations.
Method of administration and doses
Before use, the contents of the bottle should be shaken well. To dispense the drops, hold the bottle vertically with the pipette tip down. A measuring cup for measuring the dose, with a scale in millimeters, is attached to the bottle cap. If necessary, for example, when using a dose of 25 drops and above, use this measuring cup to measure the dose instead of the pipette tip. 25 drops equals 1 ml of the drug (100 mg of simethicone).
For the symptomatic treatment of digestive system disorders caused by gas formation.
The drug should be used during or after meals, and if necessary, before bedtime. The duration of treatment depends on the presence of complaints.
Infants: 5-10 drops per bottle with each feeding or 5-10 drops before each breastfeeding (given to the baby using a teaspoon).
Children 1-6 years old: 10 drops 3-5 times a day.
Children 6-14 years old: 10-20 drops 3-5 times a day.
Children from 14 years of age and adults: 20 drops 3-5 times a day.
To prepare for an X-ray or ultrasound examination.
Adults: 1 ml after meals 3 times a day before the examination and 1 ml in the morning on the day of the examination.
As an additive to the contrast medium suspension.
Adults: 2-4 ml per 1 liter of suspension for double contrast.
To prepare for gastroduodenoscopy.
Adults: 2-3 ml before the examination. If necessary, a few more milliliters of emulsion can be administered through the instrument channel of the endoscope during the examination.
As an antidote for surfactant poisoning, depending on the severity of the poisoning
Adults: 4-8 ml once. Children: 1-4 ml once.
Children
The drug is used in pediatric practice.
Overdose
To date, there are no known cases of overdose. Since simethicone is chemically and physiologically inert, intoxication is practically excluded. Even a significant amount of Espumisan-baby is well tolerated without any symptoms of intoxication. In case of using doses higher than recommended, you should consult a doctor.
Adverse reactions
In isolated cases, skin hypersensitivity reactions, including itching, skin rash, and urticaria, have been observed when using the drug.
Expiration date
For a closed bottle – 3 years, after first opening – 6 months. Do not use the drug after the expiration date indicated on the package.
Storage conditions
No special storage conditions are required.
Packaging
30 ml or 50 ml in a bottle with a dropper and a screw cap; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
BERLIN-CHEMI AG.
Location of the manufacturer and its business address
Glienicker Weg 125, 12489, Berlin, Germany.
