Espumisan 100 mg/ml

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

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

Espumisan 100 mg/ml

oral drops, emulsion
Simeticone

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 the 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 additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 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. Contents of the package 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.

Application

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

• for the symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, e.g. bloating or increased gas formation in the gastrointestinal tract;

After consulting a doctor:

• for the symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, e.g. in the case of increased gas formation 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) after consulting a doctor.

If after 3 days there is no improvement or you feel worse, you should consult your doctor.

2. Important information before using Espumisan 100 mg/ml

When not to use Espumisan 100 mg/ml:

• If you are allergic to simeticone or any of the other ingredients of this medicine (listed in section 6).
• You should also remember this when administering the medicine to other people.

Warnings and precautions

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

Children and adolescents

When using the medicine in infants and children, you 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Due to the lack of clinical trials on the use of the medicine during pregnancy, it is not recommended to use this medicine during pregnancy and breastfeeding.

Driving and using machines

Espumisan 100 mg/ml does not affect the ability to drive and use machines.

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 the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your 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.

Dosing
The dose of the medicine should be chosen based on the severity of the symptoms.

Recommended dose:

Without consulting a doctor for gastrointestinal disorders associated with excessive gas accumulation in the gastrointestinal tract.
This medicine can also be given to patients in the postoperative period after consulting a doctor.
This 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 longer than 14 days without consulting a doctor.
This medicine can be used for a longer period only if recommended by a doctor. See also section 2: "Warnings and precautions".
Before diagnostic examinations of the abdominal cavity according to the doctor's instructions.

Dosing 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.

Dosing 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.

Dosing in ml (using a measuring cup)

2 to 3 ml before the examination
If necessary, a few ml of 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 bottle cap. If necessary (e.g. to administer a dose larger than 25 drops), the measuring cup can be detached and used instead of the dropper.

Warning: Due to the risk of ingestion, 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 the use of Espumisan 100 mg/ml

After stopping the use of the medicine, symptoms may recur.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

No side effects associated with the use of this medicine have been reported so far.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +48 22 49-21-301
fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Espumisan 100 mg/ml

The medicine should be stored in a place invisible and inaccessible to children.
Do not use this medicine after the expiration date stated on the package. The expiration date is the last day of the specified month.
There are no special storage requirements. Do not store in the refrigerator or freeze.
This medicine can be used for 6 months after the first opening of the package.
Medicines should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the package and other information

What Espumisan 100 mg/ml contains

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

What Espumisan 100 mg/ml looks like and what the package contains

Espumisan 100 mg/ml is an oral drop, emulsion, slightly viscous, white to yellowish in color. Characteristic for this product is the gradual yellowing of the emulsion.
Available package: Brown glass bottle with a dropper, screw cap with a guarantee ring, and a measuring cup, containing 30 ml of oral drops, emulsion, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

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

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza Street 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
Pharma Innovations Sp. z o. o.
Jagiellońska Street 76
03-301 Warsaw
IVA Pharm Sp. z o.o.
Drawska Street 14/1
02-202 Warsaw
Marketing authorization number in Romania, the country of export: 8749/2016/01
Parallel import authorization number: 281/18

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

United Kingdom (RMS)
Espumisan 100 mg/ml oral drops, emulsion
Bulgaria
Еспумизан комфорт 100 mg/ml перорални капки, емулсия
Czech Republic
Espumisan drops 100 mg/ml
Estonia
Espumisan 100 mg/ml
Finland
Espumisan 100mg/ml drops, emulsion
Hungary
Espumisan 100 mg/ml internal emulsion
Latvia
Espumisan 100 mg/ml oral emulsion
Poland
Espumisan 100 mg/ml
Romania
Espumisan 100 mg/ml, oral drops, emulsion
Slovenia
Espumisan 100 mg/ml, oral drops, emulsion
Slovakia
Espumisan comfort 100 mg/ml oral emulsion drops

Date of leaflet approval: 21.09.2023

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