Espumisan 100 mg/ml

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Espumisan 100 mg/ml
100 mg/ml oral drops, emulsion
Simeticonum
Please read the entire leaflet carefully before using this 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.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Contents of the leaflet

1. What Espumisan 100 mg/ml is and what it is used for
2. Important information before using Espumisan 100 mg/ml
3. How to use Espumisan 100 mg/ml
4. Possible adverse effects
5. How to store Espumisan 100 mg/ml
6. Contents of the pack and other information

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

This medicine is used for symptomatic treatment of bloating (accumulation of gas) in all age groups. It reduces the surface tension of gas bubbles present in food masses and mucus in the gastrointestinal tract, causing them to break. As a result, the released gases can be absorbed through the intestinal wall or eliminated from the gastrointestinal tract via intestinal peristalsis.
Indications
Espumisan 100 mg/ml is indicated:
Without prior consultation with a doctor:

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

Following consultation with a doctor:

• for symptomatic treatment of gastrointestinal disturbances associated with excessive gas accumulation, for example, increased gas formation in the gastrointestinal tract in the postoperative period;
• as an adjunct in patient preparation for abdominal examinations (e.g. radiological and ultrasonographic examinations, and endoscopic examinations, as an additive to the suspension of contrast agent).

If there is no improvement after 3 days or if your condition worsens, consult your doctor.

2. Important information before using Espumisan 100 mg/ml

When not to take Espumisan 100 mg/ml

• If the patient is allergic to simethicone or any of the other ingredients of this medicine (listed in section 6).
• This should also be kept in mind 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.
If new symptoms occur, a visit to the doctor is necessary. Do not take this medicine for longer than 14 days without consulting a doctor. If symptoms have not improved within this time, you should consult your doctor.
Children and adolescents
If using this medicine in infants and children, 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
No special requirements.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Due to lack of clinical data on use during pregnancy, the use of this medicine is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Espumisan 100 mg/ml does not impair the ability to drive or operate machinery.
Espumisan 100 mg/ml contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, meaning 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 certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking this medicine or giving it to a child.

3. How to use Espumisan 100 mg/ml

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

• a dropper,
• a measuring device graduated in ml. Detailed information on how to measure doses is provided below.

Dosage
The dose should be adjusted according to the severity of symptoms.
Recommended dose:
Without consulting a doctor, for gastrointestinal discomfort associated with excessive
accumulation of gas in the digestive tract.

This medicine may also be administered to patients in the postoperative period after consultation with a doctor.
This medicine may be taken directly before, during, or after meals, as needed,
including before bedtime.
Treatment should continue until symptoms subside, but not longer than 14 days without
consultation with a doctor.
This medicine may be used for prolonged periods only upon a doctor's recommendation. See also section
2: "Warnings and precautions".
Before diagnostic imaging of the abdominal cavity, according to the doctor's instructions.
Dosage in ml (using the measuring device)
1 ml three times daily the day before examination, after meals, and 1 ml in the morning on the day of examination
As an additive to the contrast suspension, after consultation with a doctor.
Dosage in ml (using the measuring device)
2 ml to 4 ml per 1 liter of contrast agent used during double-contrast imaging
Before stomach and small intestine examination (endoscopy), after consultation with a doctor.
Dosage in ml (using the measuring device)
2 to 3 ml before the examination
If necessary, several ml of the emulsion may additionally be instilled through the endoscope during the procedure to reduce foaming of gastrointestinal contents.
Instructions for use
Shake well before use!
Use of the dropper (10-25 drops)
To measure the appropriate number of drops, hold the bottle vertically with the opening facing downward.
25 drops correspond to 1 ml of emulsion (equivalent to 100 mg of simethicone).
Use of the measuring device
To facilitate dose measurement, the package contains a measuring device marked in ml, attached to the caps of bottles containing 30 and 50 ml. If necessary (e.g., for administering doses exceeding 25 drops), the measuring device may be detached and used instead of the dropper.
Warning: Due to the risk of swallowing, the measuring device should be stored out of reach of children.
Overdose of Espumisan 100 mg/ml
Taking a larger than recommended dose of this medicine will not cause poisoning. Even large doses of this medicine are well tolerated. The active substance, simethicone, reduces foaming of gastrointestinal contents purely through physical action. Simethicone 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 may be taken at any time.
Discontinuation of Espumisan 100 mg/ml
After stopping the use of this medicine, symptoms may recur.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

To date, no adverse effects related to the use of this medicinal product have been reported.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting of adverse effects allows the collection of further information on the safety of the medicinal product.

5. How to store Espumisan 100 mg/ml

Keep this medicine 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 stated month.
No special storage conditions are required.
This medicine can be used for 6 months after first opening the container.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Espumisan 100 mg/ml contains

• The active substance in Espumisan 100 mg/ml is simethicone. 1 ml of oral emulsion drops contains 100 mg of simethicone.
• The other ingredients are: macrogol stearate 40 type I, glycerol monostearate 40-55, sorbic acid, sodium hydroxide (for pH adjustment), acesulfame potassium, sodium chloride, liquid sorbitol, non-crystallizing (E 420), carbomer, sodium citrate, banana flavor, purified water.

What Espumisan 100 mg/ml looks like and contents of the pack
Espumisan 100 mg/ml is a milky white, slightly viscous emulsion in amber glass bottles of 30 ml and 50 ml capacity, equipped with a dropper, a screw cap with a tamper-evident ring, and an attached dosing spoon, all contained in a cardboard box.
For more detailed information, please 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization numbers 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 European Economic Area countries under the following names:
Bulgaria Espumisan comfort 100 mg/ml oral drops, emulsion
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