Instructions for Espumizan Baby oral drops emulsion 100 mg/ml bottle 50 ml
Composition
active ingredient: simethicone;
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. Other drugs used in case of functional disorders of the digestive tract. Silicones.
ATX code A03A X13.
Pharmacological properties
Pharmacodynamics.
Espumisan® Baby contains the active ingredient simethicone, a stable, surface-active polydimethylsiloxane. It changes the surface tension of gas bubbles present in food masses and mucus of the digestive tract, thus destroying them.
The gases released in this process can then be absorbed by the intestinal wall and also removed during peristalsis.
Simethicone has a physical effect and does not participate in chemical or enzymatic reactions.
Pharmacokinetics.
Simethicone is not absorbed after oral administration and is excreted unchanged after passing through the gastrointestinal tract.
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 the active substance or to any of the excipients listed in the "Composition" section, complete intestinal obstruction.
Interaction with other medicinal products and other types of interactions
Unknown today.
Application features
The drug should be used with caution in patients with obstructive diseases of the gastrointestinal tract.
If new complaints appear and/or complaints persist after 14 days of treatment, a clinical examination should be performed.
Due to the risk of swallowing, the measuring cup should be kept out of the reach of children.
Espumizan® Baby contains 139 mg of sorbitol in 1 ml of drops, therefore this medicine should not be taken by patients with a rare hereditary form of fructose intolerance.
Use during pregnancy or breastfeeding
There are no clinical data on the effects of Espumisan® Baby on pregnancy. Caution should be exercised when prescribing to pregnant women.
The ability to influence the reaction speed when driving or working with other mechanisms
There are no special precautions.
Method of administration and doses
Shake well before use. For proper dosing of drops, hold the bottle vertically with the pipette tip facing down. A measuring cup with a milliliter scale is attached to the cap of the 30 ml or 50 ml dropper bottle as a dosing device. If necessary (for example, when using a dose of 25 drops and above), it can be used to measure the dose instead of the pipette tip. 25 drops equals 1 ml of the drug (or 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 of baby food at each feeding or 5–10 drops before each breastfeeding (given to 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 injected through the instrument channel of the endoscope during the examination to eliminate interfering foam bubbles.
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 intoxication after using simethicone.
Since simethicone is not absorbed and is not subject to chemical and enzymatic transformation during passage through the gastrointestinal tract, intoxication is practically excluded. Even a significant amount of Espumisan® Baby is tolerated without symptoms of intoxication. In case of using doses higher than recommended, you should consult a doctor.
Side effects
In isolated cases, skin hypersensitivity reactions, including itching, skin rash, and urticaria, have been observed when using the drug.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after a medicine has been authorised plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals should report any suspected adverse reactions.
Expiration date
3 years.
The shelf life after first opening the bottle is 6 months.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
No special storage conditions are required.
Keep the medicine out of the reach of children.
Packaging
30 ml or 50 ml in a bottle with a dropper, screw cap and measuring cup; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
BERLIN-CHEMI AG.
Address
Glienicker Weg 125, 12489 Berlin, Germany.
