Espumisan baby

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESPUMISAN® BABY

Composition:

Active substance: simethicone;

1 ml of oral drops, emulsion, contains 100 mg of simethicone;

Excipients: macrogol stearate, glycerol monostearate, carbomers, sodium chloride, sodium citrate (E 331), sodium hydroxide (E 524), sorbic acid (E 200), sucralose (E 955), purified water.

Pharmaceutical form. Oral drops, emulsion.

Main physicochemical properties: low-viscosity emulsion ranging from milky white to yellowish in color.

Pharmacotherapeutic group. Agents acting on the gastrointestinal tract and metabolism. Agents used in functional gastrointestinal disorders. Other agents used in functional gastrointestinal disorders. Silicones.

ATC code A03AX13.

Pharmacological properties.

Pharmacodynamics.

Espumisan® Baby contains the active ingredient simethicone, a stable, surface-active polydimethylsiloxane. It alters the surface tension of gas bubbles present in gastrointestinal contents and mucus, thereby causing their collapse.

The released gases can then be absorbed by the intestinal wall or eliminated via intestinal peristalsis.

Simethicone exerts a physical action and does not participate in chemical or enzymatic reactions.

Pharmacokinetics.

Simethicone is not absorbed following oral administration and is excreted unchanged after passing through the gastrointestinal tract.

Clinical characteristics.

Indications.

• Symptomatic treatment of gastrointestinal complaints associated with gas formation, such as flatulence, including postoperative period; infant colic.
• As an auxiliary agent during diagnostic examinations of abdominal organs (X-ray, ultrasound) and preparation for gastro-duodenoscopy.
• As an anti-foaming agent in intoxications with surface-active substances (laundry detergents or cleaning agents).

Contraindications.

Hypersensitivity to the active substance or to any of the excipients listed in the section "Composition", complete intestinal obstruction.

Interaction with other medicinal products and other types of interactions.

Currently unknown.

Special precautions for use.

The drug should be used with caution in patients with obstructive gastrointestinal disorders.

If new complaints appear and/or complaints persist after 14 days of treatment, a clinical examination is required.

Due to the risk of accidental ingestion, the measuring cup should be stored out of reach of children.

This medicinal product contains less than 1 mmol of sodium (23 mg) per 1 ml of emulsion, i.e. it is practically sodium-free.

Use during pregnancy or breastfeeding.

There are no clinical data on the effect of Espumisan® Baby during pregnancy. Caution should be exercised when prescribing to pregnant women.

Ability to affect the reaction rate while driving or operating machinery.

No special warnings.

Method of Administration and Dosage

Shake well before use. For proper dosing of the drops, hold the bottle vertically with the dropper tip facing downward. Attached to the cap of the 30 ml or 50 ml dropper bottle is a measuring cup graduated in milliliters, which serves as a dosing device. If necessary (e.g., when administering doses of 25 drops or more), the measuring cup may be used to measure the dose instead of the dropper tip. 25 drops equal 1 ml of the medicinal product (or 100 mg of simethicone).

For symptomatic treatment of gastrointestinal disorders caused by gas formation.

Administer the medication during or after meals, and if necessary, before bedtime.

The duration of treatment depends on the presence of symptoms.

Infants: 5–10 drops added to each feeding bottle or 5–10 drops given before each breastfeeding (administered to the infant via a teaspoon).

Children 1–6 years: 10 drops 3–5 times daily.

Children 6–14 years: 10–20 drops 3–5 times daily.

Children from 14 years and adults: 20 drops 3–5 times daily.

For preparation prior to radiological or ultrasound examination.

Adults: 1 ml after each meal, three times daily, the day before examination, and 1 ml in the morning on the day of examination.

As an additive to contrast suspension.

Adults: 2–4 ml per 1 liter of suspension for double-contrast imaging.

For preparation prior to gastro-duodenoscopy.

Adults: 2–3 ml before the procedure. If necessary, additional milliliters of the emulsion may be administered during the procedure through the endoscope’s instrument channel to eliminate interfering foam bubbles.

As an antidote in poisoning with surfactants, depending on severity.

Adults: 4–8 ml as a single dose. Children: 1–4 ml as a single dose.

Children.

The medication may be used in pediatric practice.

Overdose.

There have been no reported cases of intoxication following simethicone administration.

Since simethicone is neither absorbed nor chemically or enzymatically metabolized during passage through the gastrointestinal tract, intoxication is practically impossible. Even large amounts of Espumisan® Baby are well tolerated without symptoms of intoxication. In case of administration of doses higher than recommended, medical advice should be sought.

Adverse reactions.

Hypersensitivity reactions have been reported, including urticaria, rash, erythema, pruritus, allergic dermatitis, and other skin reactions, with medicinal products containing simethicone. The frequency of these reactions cannot be estimated from the available data (frequency unknown).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report any suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Shelf life after first opening of the bottle – 6 months.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep the medicinal product out of the reach of children.

Do not refrigerate or freeze.

Packaging.

30 ml or 50 ml in a bottle with a dropper cap, screw cap, and measuring cup; 1 bottle in a cardboard box.

Classification of release.

Over-the-counter (without prescription).

Manufacturer.

BERLIN-CHEMIE AG.

Manufacturer's address and place of business.

Glienicker Weg 125, 12489 Berlin, Germany.