Espumisan® l
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESPUMISAN® L (ESPUMISAN® L)
Composition:
Active substance: simeticone
1 ml of oral drops, emulsion (25 drops) contains 40 mg of simeticone;
Excipients: polyethylene glycol stearate, glycerol monostearate, carbomers, banana flavoring*, potassium acesulfame, sorbitol solution, non-crystallizing (E 420), sodium chloride, sodium citrate, sodium hydroxide, sorbic acid, purified water.
* Contains flavoring substances identical to natural ones, and propylene glycol.
Pharmaceutical form. Oral drops, emulsion.
Main physicochemical properties. Low-viscosity emulsion of milky-white color.
Pharmacotherapeutic group. Agents used in functional gastrointestinal disorders. Other agents used in functional gastrointestinal disorders. Silicones. ATC code A03A X13.
Pharmacological properties.
Pharmacodynamics.
Espumisan® L contains as active substance simethicone – a stable surface-active polydimethylsiloxane. It alters the surface tension of gas bubbles present in the intestinal contents and mucus of the gastrointestinal tract, causing them to break down. The released gases can then be absorbed by the intestinal walls or eliminated via intestinal peristalsis.
Simethicone exerts a purely physical action; it does not participate in chemical reactions and is inert pharmacologically and physiologically.
Pharmacokinetics.
Simethicone is not absorbed after oral administration and is excreted unchanged via the gastrointestinal tract.
Clinical characteristics.
Indications.
- For symptomatic treatment of gastrointestinal complaints associated with gas formation, such as flatulence and infant colic.
- As an auxiliary agent in diagnostic examinations of the abdominal cavity, such as X-ray imaging, ultrasound diagnostics, and preparation for gastroscopy.
- As an anti-foaming agent in intoxications with surface-active substances (e.g. detergents or cleaning agents).
Contraindications.
Hypersensitivity to the active substance or to any of the excipients, complete intestinal obstruction.
Interaction with other medicinal products and other forms of interaction.
Currently unknown.
Special precautions for use.
When gastrointestinal symptoms first appear and/or persist, a clinical examination should be performed.
This medicinal product contains sorbitol. Patients with rare hereditary fructose intolerance should not use this medicinal product.
Espumisan® L should be used with caution in patients with obstructive gastrointestinal disorders.
Use during pregnancy or breastfeeding.
No adverse effects are expected during pregnancy or breastfeeding, as the systemic effect of simethicone is negligible. Espumisan® L can be used during pregnancy and breastfeeding.
Fertility.
Non-clinical data do not indicate any specific risk to humans regarding fertility.
Ability to affect reaction speed when driving or operating machinery.
Espumisan® L has no effect or has a negligible effect on the ability to drive or operate machinery.
Method of administration and dosage.
Dosage.
25 drops correspond to 1 ml of the emulsion.
For symptomatic treatment of gastrointestinal complaints associated with gas formation
- for example, in meteorism, in infant colic:
| Age |
Dosage in drops |
Frequency of administration |
|
| Children under 1 year |
25 drops (1 ml) added to a bottle of infant formula with each feeding, or administered with a small spoon before or after breastfeeding |
||
| Children 1 – 6 years old |
25 drops (1 ml) |
3 – 5 times daily |
|
| Children 6 – 14 years old |
25 – 50 drops (1–2 ml) |
3 – 5 times daily |
|
| Children from 14 years and adults |
50 drops (2 ml) |
3 – 5 times daily |
|
As an adjunct in diagnostic examinations of the abdominal cavity
- Radiological examination, ultrasound diagnostics:
| The day before the procedure |
In the morning on the day of the procedure |
| 2 mL three times a day (50 drops three times a day) |
2 mL (50 drops) |
- As an additive to suspensions of contrast agents:
| 4 – 8 ml (100 – 200 drops) per 1 liter of contrast agent suspension for double-contrast imaging |
- For preparation for gastro-duodenoscopy:
| Before endoscopy, apply 4 – 8 mL (100 – 200 drops) If necessary, during the procedure several milliliters of the emulsion can be administered through the endoscope's instrument channel to eliminate gas bubbles |
As an antidote in cases of poisoning with surfactants:
Depending on the severity of poisoning:
| Age |
Dosage |
| Children |
2.5 – 10 ml (from 65 drops to 1/3 of the bottle content) |
| Adults |
10 – 20 ml (from 1/3 to 2/3 of the bottle content) |
Method of administration.
Espumisan® L should be taken during or after meals, and if necessary – before bedtime.
Espumisan® L can also be used in the postoperative period.
Shake well before use; when dosing the drops, hold the bottle vertically with the opening facing downward.
The duration of treatment depends on the presence of symptoms and is determined individually by a physician.
If necessary, Espumisan® L can be used for a prolonged period (see section "Special instructions").
Children.
The medicinal product can be used in pediatric practice.
Overdose.
Cases of overdose have not been reported to date. Since simethicone is chemically and physiologically inert, intoxication is practically impossible. Even large amounts of Espumisan® L are well tolerated without symptoms. In case of ingestion of doses higher than recommended, medical advice should be sought.
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).
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after a medicinal product has been authorized is important. It allows continued 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 through the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.
Shelf life.
3 years.
Shelf life after first opening – 6 months.
Do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions.
No special storage conditions required. Keep out of reach of children!
Packaging.
30 ml or 50 ml in a bottle with dropper insert and cap; 1 bottle in a cardboard box.
Availability.
Over-the-counter (without prescription).
Manufacturer.
BERLIN-CHEMIE AG.
Manufacturer's location and address of its business site.
Glienicker Weg 125, 12489 Berlin, Germany.