Espumisan 100 mg/ml

Package Leaflet: Information for the User

Espumisan 100 mg/ml

100 mg/ml oral drops, emulsion
simeticone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

Package Leaflet Contents

• 1. What is Espumisan 100 mg/ml and what is it used for
• 2. Important information before using Espumisan 100 mg/ml
• 3. How to use Espumisan 100 mg/ml
• 4. Possible side effects
• 5. How to store Espumisan 100 mg/ml
• 6. Package contents and other information

1. What is Espumisan 100 mg/ml and what is it used for

This medicine is used for the symptomatic treatment of bloating (gas accumulation) in all age groups. It reduces the surface tension of gas bubbles contained in food masses and in the gastrointestinal tract mucus, causing them to burst. This allows the released gases to be absorbed through the intestinal wall or eliminated from the gastrointestinal tract as a result of intestinal peristalsis.

Indications

Espumisan 100 mg/ml is used:
Without consulting a doctor:

• for the symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, such as bloating or increased gas production in the gastrointestinal tract;

After consulting a doctor:

• for the symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, such as increased gas production in the gastrointestinal tract in the postoperative period;
• as an adjunct in preparing patients for abdominal cavity examinations (e.g., radiological and ultrasonographic examinations and endoscopic examinations, as an addition to the contrast agent suspension).

If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using Espumisan 100 mg/ml

When not to use Espumisan 100 mg/ml

• If the patient is allergic to simeticone or any of the other ingredients of this medicine (listed in section 6).
• This should also be remembered when administering the medicine to other people.

Warnings and precautions

Before starting to use Espumisan 100 mg/ml, the patient should discuss it with their doctor or pharmacist.
In case of new symptoms, a doctor's visit is necessary. The medicine should not be used for more than 14 days without consulting a doctor. If the symptoms have not resolved by then, the patient should consult a doctor.

Children and adolescents

When using the medicine in infants and children, the patient should consult a doctor.

Espumisan 100 mg/ml and other medicines

No interactions with other medicines are known.

Espumisan 100 mg/ml with food and drink

There are no special requirements.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Due to the lack of clinical studies on the use of the medicine during pregnancy, caution should be exercised when prescribing the medicine to pregnant women.

Driving and using machines

No special precautions are required.

Espumisan 100 mg/ml contains sodium

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

3. How to use Espumisan 100 mg/ml

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The dose of Espumisan 100 mg/ml can be measured in two ways.
Depending on the dose size, the dose can be measured using:

• a dropper,
• a measuring cup with a scale in ml. Detailed information on how to measure doses can be found below.

Dosage
The dose of the medicine should be chosen based on the severity of the symptoms.
The recommended dose is:
Without consulting a doctor for gastrointestinal disorders associated with excessive gas accumulation in the gastrointestinal tract.
The medicine can also be given to patients in the postoperative period after consulting a doctor.
The medicine can be taken directly before, during, or after a meal, and if necessary, also before bedtime.
Treatment should be continued until the symptoms resolve, but not for more than 14 days without consulting a doctor.
The medicine can be used for a longer period only if advised by a doctor. See also section 2: "Warnings and precautions".
Before diagnostic examinations of the abdominal cavity, as advised by a doctor.

Dosage in ml (using a measuring cup)

1 ml 3 times a day the day before the examination, after meals, and 1 ml in the morning on the day of the examination
As an addition to the contrast agent suspension after consulting a doctor.

Dosage in ml (using a measuring cup)

2 ml to 4 ml per 1 liter of contrast agent used during the examination with double contrast
Before stomach and small intestine examination (endoscopy) after consulting a doctor.

Dosage in ml (using a measuring cup)

2 to 3 ml before the examination
If necessary, a few ml of the emulsion can be added to the endoscope during the examination to reduce foaming of the gastrointestinal tract contents
Method of administration

Shake before use!
Using a dropper (10-25 drops)
To measure the correct number of drops, the bottle should be held vertically, with the opening facing down.
25 drops correspond to 1 ml of emulsion (which corresponds to 100 mg of simeticone).
Using a measuring cup
To enable dosing, a measuring cup with a scale in ml is included in the package, attached to the cap of the bottles containing 30 and 50 ml. If necessary (e.g., to administer a dose larger than 25 drops), the measuring cup can be detached and used instead of the dropper.
Note: Due to the risk of swallowing, the measuring cup should be stored in a place inaccessible to children.

Overdose of Espumisan 100 mg/ml

Taking a large dose of this medicine will not cause poisoning. Even large doses of this medicine are well tolerated. The active substance of this medicine is simeticone, which physically reduces foaming of the gastrointestinal tract contents. Simeticone is not absorbed and does not undergo chemical or enzymatic transformations in the gastrointestinal tract.

Missed dose of Espumisan 100 mg/ml

A missed dose can be taken at any time.

Stopping use of Espumisan 100 mg/ml

After stopping the use of the medicine, symptoms may recur.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
For medicines containing simeticone, hypersensitivity reactions, including urticaria, rash, skin redness, itching, allergic dermatitis, and other skin reactions, have been reported. The frequency cannot be estimated from the available data (frequency unknown).

Reporting side effects

If side effects occur, including those not listed in this package leaflet, the patient should inform their doctor or pharmacist, or nurse.
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
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store Espumisan 100 mg/ml

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not store in the refrigerator or freeze.
The medicine can be used for 6 months after the first opening of the package.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Espumisan 100 mg/ml contains

The active substance of Espumisan 100 mg/ml is simeticone.
1 ml of oral emulsion contains 100 mg of simeticone.
The other ingredients are: macrogol stearate, glycerol monostearate 40-55, sorbic acid (E 200), sodium hydroxide (E 524) (for pH correction), sodium chloride, carbomers, sodium citrate (E 331), sucralose (E 955), purified water.

• The medicine is a white emulsion with a low viscosity in orange glass bottles with a capacity of 30 ml and 50 ml, with a dropper, a screw cap with a tear-off ring, and a measuring cup.
• A characteristic feature of this product is the gradual yellowing of the emulsion.
• Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

BERLIN-CHEMIE AG (MENARINI GROUP)
Glienicker Weg 125
12489 Berlin, Germany
To obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: + 48 22 566 21 00
Fax: + 48 22 566 21 01

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Еспумизан комфорт 100 mg/ml перорални капки, емулсия
Czech Republic
Espumisan
Estonia
Espumisan 100 mg/ml
Hungary
Espumisan 100 mg/ml belsőleges emulziós cseppek
Latvia
Espumisan 100 mg/ml pilieni iekšķīgai lietošanai, emulsija
Poland
Espumisan 100 mg/ml
Romania
Espumisan 100 mg/ml, picături orale, emulsie
Slovenia
Espumisan 100 mg/ml, peroralne kapljice, emulzija
Slovakia
Espumisan comfort 100 mg/ml perorálne emulzné kvapky
Date of last revision of the package leaflet:03/2025