Instructions for Espumizan soft capsules 40 mg No. 25
Composition
active ingredient: simethicone;
1 soft capsule contains simethicone 40 mg;
excipients: methylparaben (E 218), gelatin, glycerin (85%), sunset yellow FCF (E 110), quinoline yellow (E 104).
Dosage form
Soft capsules.
Main physicochemical properties: almost round, yellow, soft, gelatin capsules with a nominal diameter of 5 mm, having a seam and a smooth surface. The contents of the capsule are a viscous colorless liquid that may be slightly cloudy.
Pharmacotherapeutic group
Drugs affecting the digestive system and metabolism. Drugs for use in functional bowel disorders. ATX code A03A X13.
Pharmacological properties
Pharmacodynamics
Espumisan contains simethicone as an active ingredient - a stable surface-active polydimethylsiloxane. It changes the surface tension of gas bubbles in the contents of the stomach and intestines and in the mucus of the digestive tract, as a result of which these bubbles collapse. The gases released in the process can then be absorbed by the intestinal walls and excreted under the action of intestinal peristalsis. The action of simethicone is exclusively physical in nature, it does not participate in chemical reactions and is inert in pharmacological and physiological terms.
Pharmacokinetics
Simethicone is not absorbed after oral administration and is excreted unchanged after passing 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 studies of repeated dose toxicity, indicate no special hazard for humans with respect to carcinogenicity and reproductive toxicity.
Indication
For symptomatic treatment of gastrointestinal complaints caused by increased gas accumulation, e.g. bloating, flatulence. As an aid in the diagnosis of abdominal organs, in particular during X-ray examination, ultrasound examination (US) of the abdominal organs.
Espumizan is indicated for use in children aged 6 years and older, adolescents, and adults.
Contraindication
Hypersensitivity to the active substance, sunset yellow FCF (E 110), methylparaben (E 218) or to any of the excipients listed in the "Composition" section. Intestinal obstruction, obstructive diseases of the gastrointestinal tract.
Interaction with other medicinal products and other types of interactions
Unknown today.
Application features
In case of recurrence and/or prolonged complaints from the digestive tract, a clinical examination of the patient should be performed.
Ability to influence reaction speed when driving vehicles or other mechanisms
Espumizan has no or negligible influence on the ability to drive and use machines.
Use during pregnancy or breastfeeding
Pregnancy and breastfeeding.
No effects are expected during pregnancy and lactation, as the systemic effect of simethicone is negligible. There are no clinical data on the use of Espumisan in pregnant women.
Fertility.
Preclinical data indicate no special hazard for humans with respect to fertility.
Method of administration and doses
Take Espumizan during or after meals, and if necessary, before bedtime.
Espumizan can also be used in the postoperative period.
The duration of use depends on the presence of complaints.
If necessary, Espumizan can be used for a long time (see the section "Features of use").
Dosage.
For complaints from the gastrointestinal tract (flatulence, bloating)
| Age | Dosage | Frequency of use |
| Children aged 6 years and over, adolescents and adults | 2 capsules (equivalent to 80 mg simethicone) | 3–4 times a day |
As an aid in the diagnosis of abdominal organs (X-ray examination, ultrasound examination)
| The day before the study | On the morning of the study day |
2 capsules 3 times a day (equivalent to 240 mg simethicone) | 2 capsules (equivalent to 80 mg of simethicone) |
Children
Espumisan is not recommended for children under 6 years of age and infants. Other dosage forms are available.
Overdose
No cases of overdose have been reported. Since simethicone is chemically and physiologically completely inert, intoxication is practically excluded. Even the use of a significant amount of Espumisan is tolerated asymptomatically.
Adverse reactions
No adverse reactions associated with the use of Espumisan have been observed to date. Yellow FCF (E 110) may cause allergic reactions. Methylparaben (E 218) may cause hypersensitivity reactions, including delayed type, including itching, rash, urticaria.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions after a medicinal product has been authorised plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
25 soft capsules in a blister; 1 blister 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.
