Espumisan 100 mg/ml

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Espumisan 100 mg/ml
oral drops, emulsion
Simeticonum
Please read this 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 patient leaflet or as directed by
a 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, contact your doctor.

Table of 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 side 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 the symptomatic treatment of bloating (accumulation of gas) in all age groups. It reduces the surface tension of gas bubbles present in gastrointestinal contents and mucus, 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 consultation with a doctor:

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

After consultation with a doctor:

• for the 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 contrast medium suspension).

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, consult 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, consult your doctor.
Children and adolescents
When 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 child, she should consult her doctor or pharmacist before using this medicine.
Due to the lack of clinical studies on the use of this medicine during pregnancy, its use 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; therefore, this medicine is considered "sodium-free".

3. How to use Espumisan 100 mg/ml

This medicine should always be used exactly as described in this patient leaflet or as directed 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 instructions on how to measure doses are provided below.

Dosage
The dose should be adjusted according to the severity of symptoms.
Recommended dose:
Without prior consultation with 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 physician.
This medicine may be taken directly before, during, or after meals, as necessary,
including before bedtime.
Treatment should continue until symptoms resolve, but not longer than 14 days without
consultation with a physician.
This medicine may be used for prolonged periods only upon a physician's recommendation. See also section
2: "Warnings and precautions".
Before diagnostic examinations of the abdominal cavity, as directed by the physician.
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 contrast suspension, after consultation with a physician.
Dosage in ml (using the measuring device)
2 ml to 4 ml per 1 liter of contrast agent used
during double-contrast examinations
Before stomach and small intestine examination (endoscopy), after consultation with a physician.
Dosage in ml (using the measuring device)
2 to 3 ml before examination
If necessary, several ml of the emulsion may be additionally administered
through the endoscope during the procedure to reduce foaming of gastrointestinal contents.
Method of administration
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
For accurate dosing, the package contains a measuring device marked in ml, attached to the bottle cap. If necessary (e.g., for administering doses larger than 25 drops), the measuring device may be detached and used instead of a dropper.
Caution: Due to the risk of swallowing, the measuring device should be stored out of reach of children.
Accidental ingestion of a dose higher than recommended of Espumisan 100 mg/ml
Ingestion of a large dose of this medicine will not cause poisoning. Even large doses of this medicine are well tolerated. The active substance in this medicine is simethicone, which reduces gastrointestinal foam purely through physical action. Simethicone is not absorbed and does not undergo chemical or enzymatic transformation 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 medicine, symptoms may recur.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

To date, no adverse reactions related to the use of this medicine have been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions 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 adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Espumisan 100 mg/ml

Keep this medicine out of the 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 instructions are required. Do not store in a refrigerator or freeze.
This medicine can be used for 6 months after first opening the container.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Espumisan 100 mg/ml contains

• The active substance in Espumisan 100 mg/ml is simethicone. 1 ml of oral drops, emulsion contains 100 mg of simethicone.
• Other ingredients are: polyoxyethylene 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 contents of the pack
Espumisan 100 mg/ml is an oral emulsion, slightly viscous, milky white to yellowish in colour. A gradual yellowing of the emulsion is characteristic of this product.
Pack available: Brown glass bottle with dropper, tamper-evident cap and measuring spoon, containing 30 ml of oral drops, emulsion, in a cardboard box.
For further detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, 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.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
Marketing authorisation number in Romania, country of export: 8749/2016/01
Parallel import authorisation number: 281/18
This medicinal product is authorised for use in the European Economic Area countries 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 kapky 100 mg/ml
Estonia Espumisan 100 mg/ml
Finland Espumisan 100mg/ml tipat, emulsio
Hungary Espumisan 100 mg/ml belsőleges emulzió
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