Espumisan 100 mg/ml

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Espumisan 100 mg/ml

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 consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Espumisan 100 mg/ml and what is it used for
• 2. Important information before taking Espumisan 100 mg/ml
• 3. How to take Espumisan 100 mg/ml
• 4. Possible side effects
• 5. How to store Espumisan 100 mg/ml
• 6. Contents of the packaging 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).

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

2. Important information before taking Espumisan 100 mg/ml

When not to take 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 take 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 take this medicine for more than 14 days without consulting a doctor. If the symptoms have not subsided within this time, you should consult a 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Due to the lack of clinical studies 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".

Espumisan 100 mg/ml contains sorbitol

Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child.

3. How to take 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 doubts, you should consult a 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 selected 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.
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 subside, but not longer than 14 days without consulting a doctor.
This medicine can be taken for a longer period only if recommended by a doctor. See also section 2: "Warnings and precautions".
Before abdominal cavity examinations, as directed by the 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 poured into 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 the 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 packaging, 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.

Taking a higher dose of Espumisan 100 mg/ml than recommended

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.

Missing a 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 a 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 any side effects occur, including any possible side effects not listed in the 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will allow for the collection of 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 expiry date stated on the packaging. The expiry date refers to the last day of the given month.
There are no special storage requirements.
This medicine can be used for 6 months after the first opening of the packaging.
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 packaging 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 40 stearate type I, glycerol monostearate 40-55, sorbic acid, sodium hydroxide (for pH adjustment), acesulfame potassium, sodium chloride, sorbitol liquid, non-crystallizing (E 420), carbomer, sodium citrate, banana flavor, purified water.

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

Espumisan 100 mg/ml is a milky white, slightly viscous emulsion in orange glass bottles with a capacity of 30 ml and 50 ml with a dropper, a screw cap with a guarantee ring, and a measuring cup, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export:8749/2016/01
8749/2016/02
Parallel import authorization number:56/18

This medicinal product is authorized for sale 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 emulzió 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 leaflet approval: 03.01.2023
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