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.
4.9
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
Sorbitol liquid (non-crystallising) (E 420)
Carbomer
Sodium citrate
Banana flavour
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
The shelf life is 36 months
After the first opening, Espumisan 100 mg/ml oral drops, emulsion is stable for 6 more months.
The medicinal product should not be used after the expiry date.
6.4 Special precautions for storage
This medical product does not require any special storage conditions.
6.5 Nature and contents of container
Labelled 30-ml or 50-ml amber-glass bottle with dropper insert, screw-cap and
attached measuring cap
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
BERLIN-CHEMIE AG (MENARINI GROUP)
Glienicker Weg 125 12489 Berlin, Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 15548/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 19/05/2015
10 DATE OF REVISION OF THE TEXT
19/05/2015