Espumisan^® L (Emulsion) Instructions for Use

Marketing Authorization Holder

Berlin-Chemie/Menarini Pharma, GmbH (Germany)

Manufactured By

Berlin-Chemie, AG (Germany)

ATC Code

A03AX13 (Silicones)

Active Substance

Simeticone (Rec.INN registered by WHO)

Dosage Form

Espumisan® L

Oral emulsion 40 mg/1 ml: 30 ml bottle with dropper cap and measuring cap

Dosage Form, Packaging, and Composition

Oral emulsion milky-white in color, slightly viscous, with a banana odor.

Excipients: hypromellose (M.W.=3.0), sorbic acid, sodium cyclamate, sodium saccharin, banana flavor No.516060, purified water.

30 ml – dark glass bottles with a dropper cap (1) – cardboard boxes.

Clinical-Pharmacological Group

A drug reducing flatulence

Pharmacotherapeutic Group

Carminative agent

Pharmacological Action

The active component Simeticone is a surfactant that reduces the surface tension of gas bubbles in the gastrointestinal tract, causing them to break down.

The use of simeticone for the preparation and performance of diagnostic procedures prevents the occurrence of image defects caused by gas bubbles.

Pharmacokinetics

Simeticone is not absorbed from the gastrointestinal tract. It is excreted from the body unchanged.

Indications

• Symptoms of flatulence: bloating, feeling of pressure and fullness in the epigastric region, increased gas formation (including in the postoperative period, as well as in newborns and infants);
• Intestinal colic;
• Preparation for diagnostic examinations of the abdominal and pelvic organs (ultrasound, radiography), including as an additive to contrast agent suspensions for double-contrast imaging;
• Poisoning by detergents (including surfactants contained in detergents) as a defoaming agent.

ICD codes

Dosage Regimen

The drug is taken orally during or after meals, and if necessary also before bedtime.

For flatulence, adults and children over 14 years of age are prescribed 2 ml (50 drops) of emulsion 3-5 times/day; children aged 6 to 14 years – 1-2 ml (25-50 drops) 3-5 times/day; children aged 1 to 6 years – 1 ml (25 drops) 3-5 times/day; infants – 1 ml (25 drops) of the drug is added to a bottle with baby food or given with a small spoon before or after breastfeeding.

The duration of use depends on the severity of symptoms. If necessary, the drug can be taken for a long time.

For preparation for radiography and ultrasound examination of the abdominal organs, 2 ml (50 drops) are prescribed 3 times/day the day before the examination and 2 ml (50 drops) in the morning on the day of the examination.

For obtaining a double-contrast image, add 4-8 ml (100-200 drops) of emulsion per 1 liter of contrast suspension.

For poisoning by detergents, the drug is prescribed to adults 10-20 ml (1/3-2/3 of the bottle contents), children – 2.5-10 ml (65 drops – 1/3 of the bottle contents) of the drug depending on the severity of poisoning.

Adverse Reactions

No adverse reactions associated with the use of the drug have been observed.

Contraindications

• Intestinal obstruction;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Data on the possibility and safety of using the drug during pregnancy and lactation have not been provided.

Pediatric Use

Used in children according to indications in accordance with the dosage regimen.

Special Precautions

The drug can also be taken after surgeries.

The emulsion does not contain sugar and can be used in patients with diabetes mellitus.

Drug Interactions

No clinically significant interaction of the drug with other medicinal products has been established.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.