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1. Espumisan 100 Mg/1ml Oral Drops Emulsion
2. Espumisan 100 Mg/1ml Oral Drops Emulsion

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Espumisan 100 mg/ml oral drops, emulsion

100 mg/ml

Oral drops, emulsion

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance: simeticone 1 ml contains 100 mg simeticone.

Excipient: sorbitol (E420),199 mg/ml For a full list of excipients, see Section 6.1.

3    PHARMACEUTICAL FORM

Oral drops, emulsion

Milky-white, slightly viscous emulsion

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

-    For the symptomatic treatment of gas-related gastrointestinal complaints such as meteorism or increased gas formation after operations

-    As a diagnostic aid in the abdominal region (e.g. to reduce gas shadows in X-rays, sonography; endoscopic examinations; as an adjunct to contrast media suspensions)

4.2    Posology and method of administration

Dosing can take place with a dropper insert or a measuring cap with ml graduation.

25 drops are equivalent to 1 ml (or 100 mg simeticone).

In gas-related gastrointestinal complaints

Age-group	Dosage in drops
Infants	5 -10 drops each to every bottle feed or before every breast-feed*
1 - 6 years	10 drops 3 - 5 times daily
6 - 14 years	10 to 20 drops 3 - 5 times

	daily
Adolescents and adults	20 drops 3 - 5 times daily

*5 -10 drops each are put into the bottle feed or administered to the infant with a small spoon immediately before breast-feeding.

It is also possible to take Espumisan 100 mg/ml oral drops, emulsion after operations.

For the preparation of imaging examinations Dosage in ml

1 ml 3 times on the day before the examination after meals and 1 ml on the morning of the examination

As an adjunct to contrast media suspensions Dosage in ml

2 ml to 4 ml to 1 litre of contrast meal for double-contrast imaging

For the preparation of gastroduodenoscopy
Dosage in ml
2 ml to 3 ml before endoscopy
If necessary, a few more ml of the emulsion can be put through the instrument canal of the endoscope during the examination to eliminate interfering foam bubbles.

Method and duration of administration

Shake well before use!

In order to achieve dosage-compatible dropping, the bottle must be held vertically with the dropper insert facing downwards.

As a measuring device, a measuring cap with millilitre graduation is attached to the screw-cap of the 30-ml and 50-ml dropper bottles. If necessary (for example with doses of 25 drops and more), it can be pulled off and used instead of the dropper insert to measure off the dose.

Note: Due to the danger of swallowing, the measuring cup should be kept away from children.

In gas-related gastrointestinal complaints

Espumisan 100 mg/ml oral drops, emulsion is taken with or after meals, also before going to bed if necessary.

The duration of therapeutic use is in line with the course of the complaints.

If required, Espumisan 100 mg/ml oral drops, emulsion can also be taken over a long period of time.

For the preparation for imaging examinations

The recommended dose of Espumisan 100 mg/ml oral drops, emulsion is taken on the day before the examination and on the morning of the examination.

Note:

In newly occurring and/or persistent complaints, they should be clinically investigated.

4.3    Contraindications

Espumisan 100 mg/ml oral drops, emulsion should not be used in patients with hypersensitivity to the active substance simeticone or one of the other ingredients.

4.4    Special warnings and precautions for use

Espumisan 100 mg/ml oral drops, emulsion contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5    Interaction with other medicinal products and other forms of interaction

None known to date

4.6    Pregnancy and lactation

For Espumisan 100 mg/ml oral drops, emulsion, no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing to pregnant women.

4.7    Effects on ability to drive and use machines

No special precautions

4.8    Undesirable effects

Undesirable effects in association with the use of Espumisan 100 mg/ml oral drops, emulsion have not been observed to date.

Overdose

Intoxications following use of simeticone have not become known to date.

Simeticone is not absorbed and not changed chemically or enzymatically during gastrointestinal passage. Intoxication is therefore practically ruled out. Even large quantities of Espumisan 100 mg/ml oral drops, emulsion are tolerated without symptoms.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Gastrointestinal agent, polysiloxane, defoaming agent

ATC code: A03AX13, OTHER DRUGS FOR FUNCTIONAL BOWEL DISORDERS, Silicones

Espumisan 100 mg/ml oral drops, emulsion contains as the active substance simeticone, a stable, surface-active polydimethylsiloxane. It alters the surface tension of the gas bubbles embedded in the bolus and in the mucus of the digestive tract, which thus disintegrate.

The gases released in the process can then be absorbed by the intestinal wall, as well as eliminated through intestinal peristalsis.

Simeticone has a physical action and is not involved in chemical or enzymatic reactions.

5.2    Pharmacokinetic properties

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

5.3    Preclinical safety data

Simeticone behaves in a chemically inert manner and is not absorbed from the intestinal lumen. Systemic toxic effects are therefore not expected.

There are no non-clinical data on Espumisan 100 mg/ml oral drops, emulsion. Preclinical data on simeticone reveal no specific hazard for humans based on limited studies of repeated-dose toxicity, carcinogenic potential and reproductive toxicity.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol stearate Glycerol monostearate 40-55 Sorbic acid

Sodium hydroxide (for pH adjustment) Acesulfame potassium Sodium chloride

11/06/2010

DATE OF REVISION OF THE TEXT

26/02/2014