Espumisan

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Espumisan(Espumisan L)

40 mg/ml, oral drops, emulsion

Simeticonum
Espumisan and Espumisan L are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to your doctor.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Espumisan and what is it used for
• 2. Important information before taking Espumisan
• 3. How to take Espumisan
• 4. Possible side effects
• 5. How to store Espumisan
• 6. Contents of the pack and other information

1. What is Espumisan and what is it used for

Espumisan contains the active substance simethicone, which is used to treat gastrointestinal disorders by reducing foaming of the gastrointestinal contents and as an auxiliary in diagnostic tests.
It can be used in all age groups.
The active substance of the medicine, simethicone, causes the breakdown of gas bubbles contained in food masses and in the mucus of the gastrointestinal tract. This allows the gases released in this way to be absorbed by the intestinal wall or removed from the gastrointestinal tract as a result of intestinal peristalsis.

Espumisan is used:

• For symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, such as bloating, infantile colic in infants over 1 month of age.
• As an auxiliary in preparing for abdominal cavity tests, such as radiological and ultrasonographic examinations, and gastroscopy.
• As a defoaming agent in poisonings with surface-active substances (detergents).

If you do not feel better or if you feel worse, you should contact your doctor.

2. Important information before taking Espumisan

When not to take Espumisan

Warnings and precautions

Before starting to take Espumisan, you should discuss it with your doctor or pharmacist.
Espumisan should not be taken by infants under 1 month of age.
In case of new or persistent abdominal complaints, you should consult your doctor to determine the cause of the complaints and diagnose any underlying disease that may require treatment.

Espumisan and other medicines

No interactions with other medicines are known.

Pregnancy, breastfeeding, and fertility

There are no restrictions on the use of Espumisan in pregnant and breastfeeding women.

Driving and using machines

No special precautions are required.

Espumisan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".

3. How to take Espumisan

This medicine should always be taken as described in the leaflet or as directed by your doctor or pharmacist.
In case of doubt, you should consult your doctor or pharmacist.

Dosage

The recommended dose is:
Symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation

• e.g., bloating, infantile colic:

Note: Espumisan can also be given to patients in the postoperative period.
Espumisan can be taken directly before a meal, during, or after a meal, and if necessary, also before bedtime.
Treatment should be continued until symptoms resolve. If necessary, Espumisan can be administered for a longer period.
In preparation for diagnostic tests of the abdominal cavity

• Radiological examination, ultrasonography:
• As an auxiliary substance administered together with the contrast agent suspension:
• 4 - 8 ml (≈ 100 - 200 drops) per 1 liter of contrast fluid used during the double-contrast examination.
• In preparing patients for upper gastrointestinal endoscopy (gastroscopy):

Before endoscopy, 4 - 8 ml (≈ 100 - 200 drops).
If necessary, a few ml of the emulsion can be instilled through the instrumental channel of the endoscope during the examination to reduce foaming of the gastrointestinal contents.
As an antidote in detergent (surface-active substance) poisoning:

Note: If Espumisan is used as a first-aid measure after ingesting a detergent, you should immediatelyconsult a doctor!

Method of administration

Shake before use.
To measure the correct number of drops, the bottle should be held vertically, with the opening facing downwards.
25 drops (1 ml of oral drops, emulsion) contain 40 mg of simethicone.
Since Espumisan does not contain sugar, it can also be given to diabetic patients and patients with eating disorders.

Overdose of Espumisan

No cases of poisoning with Espumisan have been reported so far.
The active substance of Espumisan, simethicone, causes the disappearance of foam in the gastrointestinal tract in a purely physical way and is biologically and chemically completely inactive.
Therefore, the possibility of poisoning can be practically excluded. Even large doses of Espumisan are well tolerated.

Missed dose of Espumisan

In such a case, the missed dose can be taken at any time.

Stopping the use of Espumisan

In such a case, the symptoms may return.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

In the case of medicines containing simethicone, hypersensitivity reactions, including urticaria, rash, skin redness, itching, allergic skin inflammation, and other skin reactions, have been reported. The frequency cannot be determined from the available data (frequency unknown).
Other side effects have also been reported, but since the medicinal product is practically not absorbed from the gastrointestinal tract, side effects are very rare.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Espumisan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Note on shelf life after first opening: after the first opening of the packaging, Espumisan retains its shelf life for 6 months.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Espumisan contains

The active substance of the medicine is simethicone.
25 drops (1 ml of oral drops, emulsion) contain 40 mg of simethicone.
The other ingredients are: macrogol stearate, glycerol monostearate 40-55, sodium hydroxide, sodium chloride, carbomers, sodium citrate, sucralose, sorbic acid, purified water.

What Espumisan looks like and what the pack contains

Milky white to yellowish emulsion, slightly viscous. Oral drops, emulsion.
Packaging: 30 ml glass bottle with a PP screw cap and a PE dropper, in a cardboard box, containing 30 ml of oral drops, emulsion.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Berlin-Chemie AG (Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer:

Berlin-Chemie AG (Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Latvia, the country of export: 00-0568
Parallel import authorization number: 77/25

Date of approval of the leaflet: 21.02.2025

[Information about the trademark]