Instructions Espumizan L oral drops emulsion 40 mg/ml bottle 30 ml
Composition
active ingredient: simethicone
1 ml of oral drops, emulsion (25 drops) contains simethicone 40 mg;
Excipients: polyethylene glycol stearate, glycerol monostearate, carbomers, banana flavoring*, acesulfame potassium, sorbitol non-crystallizing solution (E 420), sodium chloride, sodium citrate, sodium hydroxide, sorbic acid, purified water.
* Contains natural flavorings and propylene glycol.
Dosage form
Oral drops, emulsion.
Main physical and chemical properties: Low-viscosity emulsion of milky white color.
Pharmacotherapeutic group
Drugs used in functional disorders of the gastrointestinal tract. Other drugs used in functional disorders of the gastrointestinal tract. Silicones. ATX code A03A X13.
Pharmacological properties
Pharmacodynamics
Espumisan® L contains simethicone, a stable surface-active polydimethylsiloxane, as the active ingredient. It changes the surface tension of gas bubbles contained in food gruel and the mucous membranes of the digestive tract, causing them to disintegrate. The released gases can then be absorbed by the intestinal walls and also eliminated by intestinal peristalsis.
Simethicone has an exclusively physical effect; it does not participate in chemical reactions and is inert in pharmacological and physiological terms.
Pharmacokinetics
Simethicone is not absorbed when taken orally and is excreted unchanged through the gastrointestinal tract.
Indication
For symptomatic treatment of gastrointestinal complaints associated with gas formation, e.g. flatulence, colic in infants. As an aid in diagnostic examinations of the abdominal cavity, such as X-ray examinations, ultrasound diagnostics and preparation for gastroduodenoscopy. As an antifoam in intoxications with surfactants (washing powders or detergents).
Contraindication
Hypersensitivity to the active substance or to any of the excipients, complete intestinal obstruction.
Interaction with other medicinal products and other types of interactions
Unknown today.
Application features
At the first appearance and/or persistent complaints of abdominal disorders, a clinical examination should be performed.
This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Espumisan® L should be used with caution in patients with obstructive gastrointestinal diseases.
Ability to influence reaction speed when driving vehicles or other mechanisms
Espumizan® L has no or negligible influence on the ability to drive or use machines.
Use during pregnancy or breastfeeding
No effects are expected during pregnancy and breastfeeding, as the systemic exposure to simethicone is negligible. Espumisan® L can be used during pregnancy and breastfeeding.
Fertility
Non-clinical data do not indicate a special hazard for humans with respect to fertility.
Method of administration and doses
Doses.
25 drops correspond to 1 ml of emulsion.
For symptomatic treatment of gastrointestinal complaints associated with gas formation, e.g. flatulence, colic in infants:
| Age | Dosage in drops | Frequency of use |
| Children under 1 year old | Add 25 drops (1 ml) to a baby food bottle at each feeding or give with a small spoon before or after breastfeeding. | |
| Children aged 1 – 6 years | 25 drops (1 ml) | 3 – 5 times a day |
| Children aged 6 – 14 years | 25 – 50 drops (1-2 ml) | 3 – 5 times a day |
| Children aged 14 and over and adults | 50 drops (2 ml) | 3 – 5 times a day |
As an aid in diagnostic studies of the abdominal cavity
X-ray examination, ultrasound diagnostics:
| The day before the study | Morning of the study day |
| 2 ml 3 times a day (50 drops 3 times a day) | 2 ml (50 drops) |
As an additive to contrast agent suspension:
4 – 8 ml (100 – 200 drops) per 1 liter of contrast medium suspension for double-contrast imaging
To prepare for gastroduodenoscopy:
Before endoscopy, use 4 – 8 ml (100 – 200 drops)
If necessary, several milliliters of emulsion can be injected through the endoscope's instrument channel during the examination to eliminate gas bubbles.
As an antidote for surfactant poisoning
Depending on the severity of the poisoning:
| Age | Dosage |
| Children | 2.5 – 10 ml (from 65 drops to 1/3 of the bottle contents) |
| Adults | 10 – 20 ml (1/3 to 2/3 of the bottle contents) |
Espumizan® L should be taken during or after meals, and if necessary, before bedtime.
Espumisan® L can also be used in the postoperative period.
Shake before use; to dispense drops, hold the bottle vertically with the opening down.
The duration of treatment depends on the presence of complaints and is decided by the doctor individually.
If necessary, Espumizan® L can be used for a long time (see the section "Special instructions for use")
Children
The drug can be used in pediatric practice.
Overdose
To date, there are no known cases of overdose. Since simethicone is chemically and physiologically inert, intoxication is practically excluded. Even a significant amount of Espumisan® L is tolerated without symptoms. In case of taking doses higher than recommended, you should consult a doctor.
Adverse reactions
In isolated cases, skin hypersensitivity reactions, including itching, skin rash, and urticaria, have been observed with the use of Espumisan® L.
Reporting of suspected adverse reactions
If you notice any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. It is very important to report suspected side effects after the medicine has been authorised. This allows for continuous monitoring of the benefit/risk balance of the medicine.
Expiration date
3 years.
The shelf life after first opening is 6 months.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
No special storage conditions are required. Keep out of the reach of children!
Packaging
30 in a bottle with a dropper insert and stopper; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
BERLIN-CHEMI AG.
Location of the manufacturer and its business address
Glienicker Weg 125, 12489 Berlin, Germany.
