Espumisan 100 mg/ml

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. 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 this leaflet for the patient or as advised by your doctor or pharmacist.

• The leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if 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 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 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 mucous membrane of the gastrointestinal tract, causing them to burst. This allows the released gases to be absorbed by 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 there is no improvement after 3 days or if the patient feels worse, they should consult their 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, you should discuss it with your doctor or pharmacist.
In case of new symptoms, a doctor's visit is necessary. This medicine should not be used for more than 14 days without consulting a doctor. If the symptoms have not subsided within this time, 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 the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her 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

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 leaflet for the patient or as advised by your doctor or pharmacist. In case of doubts, 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 selected based on the severity of the symptoms.
The recommended dose is:
Without consulting a doctor in 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 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 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 more 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, opening downwards.
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 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.

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 of the medicine 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

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 you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, 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
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 100 mg/ml

The medicine should be stored in a place invisible and inaccessible to children.
This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special storage temperature requirements. Do not store in the refrigerator or freeze.
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. 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 emulsion contains 100 mg of simeticone.
The other ingredients are:
Macrogol stearate, glycerol monostearate 40-55, sorbic acid (E 200), sodium hydroxide (E 524), sodium chloride, carbomers, sodium citrate (E 331), sucralose (E 955), purified water.

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

Espumisan 100 mg/ml is a milky white to yellowish emulsion with low viscosity in brown glass bottles with a capacity of 30 ml and 50 ml, with a dropper, a cap with a guarantee ring, and a measuring cup, in a cardboard box.
Characteristic of this product is the gradual yellowing of the emulsion.
For 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
12489 Berlin
Germany

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export:
8749/2016/01
8749/2016/02

Parallel import authorization number: 59/15

This medicinal product 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 approval of the leaflet: 24.01.2025

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