Espumisan

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESPUMISAN® (ESPUMISAN®)

Composition:

Active substance: simethicone;

1 soft capsule contains 40 mg of simethicone;

Excipients: methylparaben (E 218), gelatin, glycerol (85 %), yellow FCF (E 110), quinoline yellow (E 04).

Pharmaceutical form. Soft capsules.

Main physico-chemical properties: nearly round, yellow, soft, gelatin capsules with a nominal diameter of 5 mm, having a seam and smooth surface. The capsule contents are a viscous, colorless liquid which may be slightly cloudy.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Medicinal products used in the treatment of functional intestinal disorders.

ATC code A03A X13.

Pharmacological properties.

Pharmacodynamics.

Espumisan contains as the active ingredient simethicone – a stable surface-active polydimethylsiloxane. It alters the surface tension of gas bubbles in the gastric and intestinal contents and in the gastrointestinal mucus, resulting in the rupture of these bubbles. The released gases can then be absorbed through the intestinal walls and eliminated via intestinal peristalsis. The action of simethicone is purely physical; it does not participate in chemical reactions and is pharmacologically and physiologically inert.

Pharmacokinetics.

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

Preclinical safety data.

Simethicone is chemically inert and is not absorbed from the intestinal lumen. Systemic toxic effects are not expected. Preclinical data based on conventional repeated-dose toxicity studies indicate no special hazard for humans regarding carcinogenicity or toxic effects on reproductive function.

Clinical characteristics.

Indications.

• For symptomatic treatment of gastrointestinal tract complaints caused by excessive gas accumulation, such as bloating and flatulence.
• As an adjunctive agent in diagnostic procedures of abdominal organs, particularly in X-ray examinations and ultrasound examinations (US) of abdominal organs.

Espumisanâ is indicated for use in children aged 6 years and older, adolescents, and adults.

Contraindications.

Hypersensitivity to the active substance, to the dye Yellow West FCF (E 110), methylparaben (E 218), or to any other excipient listed in the section "Composition". Intestinal obstruction, obstructive gastrointestinal tract disorders.

Interaction with other medicinal products and other forms of interaction.

Currently unknown.

Special precautions for use.

In case of recurrence and/or presence of persistent gastrointestinal complaints, a clinical examination of the patient should be performed.

Use during pregnancy or breastfeeding.

Pregnancy and breastfeeding.

No adverse effects are expected during pregnancy or lactation, as the systemic action of simethicone is negligible. There are no clinical data on the use of Espumisan® in pregnant women.

Fertility.

Preclinical data indicate no specific risk to humans regarding fertility.

Ability to influence reaction speed when driving or operating machinery.

Espumisan® has no effect or has negligible effect on the ability to drive and operate machinery.

Method of administration and dosage.

Take Espumisanâ during or after meals, and if necessary, before bedtime.

Espumisanâ can also be used in the postoperative period.

The duration of use depends on the presence of symptoms.

If needed, Espumisanâ may be used for a prolonged period (see section "Special instructions").

Dosage.

For gastrointestinal complaints (flatulence, bloating)

As an adjunct in the diagnosis of abdominal organs (radiographic examination, ultrasound examination)

Children.

Espumisanâ is not recommended for children under 6 years of age and infants. Other dosage forms are available.

Overdose.

There have been no reports of overdose. Since simethicone is chemically and physiologically completely inert, intoxication is practically impossible. Even administration of a large amount of Espumisanâ is well tolerated without symptoms.

Side effects.

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

Yellow FCF (E 110) may cause allergic reactions. Methylparaben (E 218) may cause hypersensitivity reactions, including delayed-type reactions such as pruritus, rash, and urticaria.

Reporting suspected adverse reactions.

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

Shelf life. 3 years.

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

Storage conditions. Store at a temperature not exceeding 30 °C. Keep out of reach and sight of children.

Packaging. 25 soft capsules in a blister; 1, 2, or 4 blisters per cardboard box.

Availability category. Over-the-counter (without prescription).

Manufacturer.

BERLIN-CHEMIE AG.

Manufacturer's address and place of business.

Glinker Weg 125, 12489 Berlin, Germany.