Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is in a foreign language.
Espumisan (Espumisan Emulsion)
40 mg/ml, oral drops, emulsion
Simeticonum
Espumisan and Espumisan Emulsion are different brand names for the same medicine.
Please read the entire 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 for future reference.
If you need advice or further information, consult your doctor or pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents of the leaflet:

What Espumisan is and what it is used for
Important information before taking Espumisan
How to take Espumisan
Possible side effects
How to store Espumisan
Contents of the pack and other information

1. What Espumisan is and what it is used for

Espumisan contains the active substance simeticone, which is an agent used in gastrointestinal disorders to reduce foaming in the gastrointestinal tract and is also used as an adjunct in diagnostic examinations.
It can be used in all age groups.
The active ingredient in the medicine, simeticone, breaks down gas bubbles present in gastrointestinal contents and mucus. This allows the released gases to be absorbed through the intestinal wall or eliminated from the gastrointestinal tract via intestinal peristalsis.
Espumisan is used:

For symptomatic treatment of gastrointestinal disturbances associated with excessive gas accumulation, such as bloating, infantile colic in infants over 1 month of age.
As an adjunct in preparation for abdominal examinations, such as radiological and ultrasonographic imaging, and gastroscopy.
As an agent to reduce foaming in poisoning with surface-active agents (detergents).

If there is no improvement or if you feel worse, consult your doctor.

2. Important information before using Espumisan

When not to use Espumisan:

if the patient is allergic to simethicone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Espumisan, consult your doctor or pharmacist.
Espumisan must not be used in infants during the first month of life.
If new and/or persistent gastrointestinal symptoms occur, consult a doctor to determine the cause and to diagnose any underlying disease responsible for such symptoms.

Espumisan and other medicines
No interactions with other medicines are known.

Use with food and drink
During treatment with Espumisan, avoid consuming carbonated beverages. Espumisan may be taken directly before, during, or after meals, and, if necessary, also before bedtime.

Infants
Espumisan should be added to the bottle with milk and/or food, or administered with a spoon before or after breastfeeding.

Pregnancy, breastfeeding and fertility
Before using any medicine, consult your doctor or pharmacist.
There are no restrictions on the use of Espumisan during pregnancy and breastfeeding.

Driving and operating machinery
No special precautions are required.

Espumisan contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml; therefore, the medicine is considered "sodium-free".

3. How to use Espumisan

This medicine should always be used according to the instructions in the leaflet or as directed by a doctor.
If in doubt, consult a doctor or pharmacist.
Dosage
The dose can be measured using the dropper.
More detailed information on the use of the dropper can be found in the section "Instructions for use".
Recommended dose:
Symptomatic treatment of gastrointestinal discomfort associated with excessive accumulation of gas, such as bloating and infantile colic in infants over 1 month of age:

Age group	Dosage
Infants over 1 month of age	1 ml - 2 ml (25 - 50 drops), corresponding to 40 - 80 mg of simethicone per day, in 2 (2 times daily, 13 - 25 drops each) to 4 (4 times daily, 6 - 13 drops each) divided doses; total daily dose should not exceed 80 mg; Espumisan should be added to the milk bottle or administered with a spoon before or after breastfeeding.
Children from 1 to 6 years	1 ml (25 drops), corresponding to 40 mg of simethicone, 3 to 5 times daily.
Children from 6 to 14 years	1 ml (25 drops) - 2 ml (50 drops), corresponding to 40 - 80 mg of simethicone, 3 to 5 times daily.
Adolescents and adults	2 ml (50 drops), corresponding to 80 mg of simethicone, 3 to 5 times daily.

Warning: Espumisan may also be administered to patients in the postoperative period.
Espumisan may be taken during or after meals, and if necessary, also before bedtime.
Treatment should continue until symptoms resolve. If necessary, Espumisan may be administered for a prolonged period.

Preparation for abdominal diagnostic imaging:

Radiological and ultrasonographic examinations: 2 ml (50 drops) of Espumisan three times daily on the day before the examination, and 2 ml (50 drops) of Espumisan in the morning on the day of the examination, on an empty stomach.
As an auxiliary substance administered together with a contrast medium suspension: For double-contrast imaging, 4 to 8 ml (100 to 200 drops) of Espumisan per 1 liter of contrast fluid is used.
In preparation of patients for upper gastrointestinal endoscopy (gastroscopy): Before endoscopy, administer 4–8 ml (equivalent to 100 to 200 drops). If necessary, additional milliliters of the emulsion may be instilled through the instrument channel of the endoscope during the procedure to reduce foaming in the gastrointestinal tract.

As an antidote in detergent poisoning (surface-active agents):
Dosage in adults
Depending on the severity of poisoning, administer 10 to 20 ml (approximately 1/3 to 2/3 of the content of a 30 ml bottle) of Espumisan.
Dosage in children
Depending on the severity of poisoning, administer 2.5 to 10 ml (from 65 drops to approximately 1/3 of the content of a 30 ml bottle) of Espumisan.
Warning: If Espumisan is used as first aid after ingestion of detergent, immediate medical attention is required!
In case of any doubts or if the effect of Espumisan seems too strong or too weak, consult a physician or pharmacist.

Method of administration
Shake well before use.
Dosage using the dropper:
To measure the appropriate number of drops, hold the bottle vertically with the opening facing downwards.
25 drops (1 ml of oral drops, emulsion) contain 40 mg of simethicone.

Use of a higher than recommended dose of Espumisan
No cases of overdose have been reported to date.
Simethicone is a chemically and physiologically inert substance that is not absorbed from the gastrointestinal tract; therefore, intoxication is practically impossible. Even large doses of Espumisan are well tolerated.

Missed dose of Espumisan
In such a case, the missed dose may be taken at any time.

Discontinuation of Espumisan
In such a case, symptoms may recur.

If you have any further questions regarding the use of this medicinal product, please consult your physician or pharmacist.

4. Possible adverse reactions

No adverse reactions related to the use of Espumisan have been reported so far.
Reporting of adverse reactions
If any adverse reactions occur, including any undesirable symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also 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
Phone: (22) 49-21-301
Fax: (22) 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of using this medicinal product.

5. How to store Espumisan

Keep the 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.
Storage conditions
Do not store above 30°C.
After first opening, the medicine remains stable for 4 weeks.

6. Contents of the packaging and other information

What Espumisan contains
The active substance in Espumisan is simethicone.
1 ml (25 drops) of oral emulsion contains 40 mg of simethicone.
Other components of the medicine are: polyglycol 1500 stearate, glycerol monostearate, sorbic acid,
hydroxypropylcellulose, sodium cyclamate, sodium saccharin, purified water.

What Espumisan looks like and contents of the pack
Low-viscosity emulsion, milky white to slightly yellowish in colour. Oral drops, emulsion.
Espumisan is available in an amber glass bottle with a dropper and screw cap containing 30 ml of oral emulsion,
packaged in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Germany, country of export, and Manufacturer:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Parallel Importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Český Těšín
Czech Republic

Repackaged in:
Euceryn Manufacturing Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw

German, country of export, Marketing Authorisation Number: 36478.00.00
Parallel Import Authorisation Number: 132/22
[Trademark information notice]