Espumisan

Leaflet attached to the packaging: patient information

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

Espumisan (Espumisan Emulsion)

40 mg/ml, oral drops, emulsion
Simeticone
Espumisan and Espumisan Emulsion are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

This drug should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's recommendations.

• You should keep this leaflet so that you can read it again if necessary.
• If you need advice or additional information, you should consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Espumisan and what is it used for
• 2. Important information before using Espumisan
• 3. How to use Espumisan
• 4. Possible side effects
• 5. How to store Espumisan
• 6. Package contents and other information

1. What is Espumisan and what is it used for

Espumisan contains the active substance simeticone, which is used in gastrointestinal disorders, reducing foaming of the gastrointestinal contents and as an auxiliary in diagnostic tests.
It can be used in all age groups.
The active substance of the drug, simeticone, causes the bursting of gas bubbles contained in food masses and in the mucus of the gastrointestinal tract. This allows the gases released in this way to be absorbed by the intestinal wall or removed from the gastrointestinal tract as a result of intestinal peristalsis.
Espumisan is used:

• In the symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, such as, for example: bloating, infantile colic in infants over 1 month of age.
• As an auxiliary in preparing for abdominal cavity tests, such as, for example, radiological and ultrasonographic examinations and gastroscopy.
• As a means of reducing foaming in poisonings with surface-active agents (detergents).

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

2. Important information before using Espumisan

When not to use Espumisan:

Warnings and precautions

Before starting to use Espumisan, you should discuss it with your doctor or pharmacist.
Espumisan should not be used in infants under 1 month of age.
In the event of new and/or persistent gastrointestinal symptoms, you should consult a doctor to determine the cause of the symptoms and possibly diagnose the underlying disease.

Espumisan and other drugs

No interactions with other drugs are known.

Using Espumisan with food and drink

While using Espumisan, you should avoid consuming carbonated beverages. Espumisan can be taken directly before, during, or after a meal, and if necessary, also before bedtime.
Infants
Espumisan should be added to a bottle with milk and/or food or given on a spoon before or after breastfeeding.

Pregnancy, breastfeeding, and fertility

Before using any drug, you should consult a doctor or pharmacist.
There are no restrictions on the use of Espumisan in pregnant and breastfeeding women.

Driving and using machines

No special precautions are required.

Espumisan contains sodium

The drug contains less than 1 mmol (23 mg) of sodium per 1 ml, which means the drug is considered "sodium-free".

3. How to use Espumisan

This drug should always be used in accordance with the leaflet or according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.

Dosage

The dose can be measured using a dropper.
More detailed information on using the dropper can be found in the "Method of administration" section.
The recommended dose is:
Symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, such as, for example: bloating and infantile colic in infants over 1 month of age:

Note: Espumisan can also be given to patients in the postoperative period.
Espumisan can be taken during or after a meal, and if necessary, also before bedtime.
Treatment should be continued until the symptoms disappear. If necessary, Espumisan can be given for a longer period.
In preparation for abdominal cavity tests:

• Radiological and ultrasonographic examination:2 ml (50 drops) of Espumisan 3 times a day 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 agent suspension:For double-contrast imaging, 4 to 8 ml (100 to 200 drops) of Espumisan per 1 liter of contrast fluid are used.
• In preparing patients for endoscopic examination of the upper gastrointestinal tract (gastroscopy):Before endoscopy, 4-8 ml (corresponding to 100 to 200 drops). If necessary, a few ml of the emulsion can be instilled through the instrumental channel of the endoscope during the examination to reduce foaming of the gastrointestinal contents.

As an antidote in detergent (surface-active agent) poisoning:
Dosage in adults
Depending on the severity of the poisoning, 10 to 20 ml (approximately 1/3 to 2/3 of the contents of the 30 ml bottle) of Espumisan are used.
Dosage in children
Depending on the severity of the poisoning, 2.5 to 10 ml (65 drops to approximately 1/3 of the contents of the 30 ml bottle) of Espumisan are used.
Note: If Espumisan is used as a first-aid measure after ingesting a detergent, you should immediatelyconsult a doctor!
In case of any doubts or feelings that the effect of Espumisan is too strong or too weak, you should contact a doctor or pharmacist.

Method of administration

Shake before use.
Dosage using a dropper:
To measure the correct number of drops, the bottle should be held vertically, with the opening facing down.
25 drops (1 ml of oral drops, emulsion) contain 40 mg of simeticone.

Using a higher dose of Espumisan than recommended

No cases of overdose have been reported so far.
Simeticone is a chemically and physiologically completely inert substance that is not absorbed from the gastrointestinal tract, so the possibility of poisoning can be practically ruled out. Even large doses of Espumisan are well tolerated.

Missing a dose of Espumisan

In such a case, the missed dose can be taken at any time.

Stopping the use of Espumisan

In such a case, the symptoms may return.
In case of any further doubts related to the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

No side effects related to the use of Espumisan have been reported so far.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department for 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: (22) 49-21-301
Fax: (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 drug.

5. How to store Espumisan

Store in a place invisible and inaccessible to children.
Do not use this drug after the expiration date stated on the packaging. The expiration date indicates the last day of the given month.
Drugs should not be thrown into the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

Storage conditions

Do not store at a temperature above 30°C.
After the first opening of the packaging, the drug remains stable for 4 weeks.

6. Package contents and other information

What Espumisan contains

The active substance of Espumisan is simeticone.
1 ml (25 drops) of oral drops, emulsion contains 40 mg of simeticone.
The other ingredients of the drug are: macrogol 1500 stearate, glycerol monostearate, sorbic acid, hydroxypropylcellulose, sodium cyclamate, sodium saccharin, purified water.

What Espumisan looks like and what the packaging contains

Emulsion with low viscosity, white to yellowish in color. Oral drops, emulsion.
Espumisan is available in a brown glass bottle with a dropper and screw cap, containing 30 ml of oral drops, emulsion, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the 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 Czeski Cieszyn
Czech Republic

Repackaged by:

Euceryna Laboratory Pharmaceutical Works 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 export license number: 36478.00.00

Parallel import license number: 132/22 Date of leaflet approval: 14.03.2022

[Information about the registered trademark]