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 medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult your doctor or pharmacist.
• If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, you should contact your 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. Contents of the packaging 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 medicine, 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 through the intestinal wall or removed from the gastrointestinal tract as a result of intestinal peristalsis.
Espumisan is used:

• For symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, such as bloating, infantile colic in infants over 1 month of age.
• As an auxiliary in preparation for abdominal cavity tests, such as radiological and ultrasonographic examinations and gastroscopy.
• As a defoaming agent in poisonings with surface-active substances (detergents).

If there is no improvement or you feel worse, you should consult your 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 case of new and/or persistent gastrointestinal symptoms, you should consult your doctor to determine the cause of the symptoms and possibly diagnose the underlying disease.

Espumisan and other medicines

No interactions with other medicines 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 or food or given on a spoon before or after breastfeeding.

Pregnancy, breastfeeding, and fertility

Before using any medicine, you should consult your 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 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

This medicine should always be used in accordance with the leaflet or as directed by your doctor. In case of doubts, you should consult your 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 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 diagnostic tests of the abdominal cavity:

• 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 the contrast agent suspension:

For double-contrast imaging, 4 to 8 ml (100 to 200 drops) of Espumisan are used per 1 liter of contrast fluid.

• In preparing patients for upper gastrointestinal endoscopy (gastroscopy):

Before endoscopy, 4-8 ml (corresponding to 100-200 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 substance) 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 ingestion of 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 your 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 medicine, you should consult your 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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

Store in a place 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 specified month.
Do not store above 30°C.
After the first opening of the packaging, Espumisan remains stable for 4 weeks.
Medicines should not be disposed of via wastewater or household waste containers. 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 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 medicine are: hydroxypropyl cellulose, sorbic acid, sodium cyclamate, sodium saccharin, glycerol monostearate, macrogol 1500 stearate, purified water.

What Espumisan looks like and what the packaging contains

Milky white to yellowish emulsion, slightly viscous. Oral drops, emulsion.
Espumisan is available in a 30 ml or 32 ml brown glass bottle with a screw cap, dropper, and measuring cup, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer:

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Germany, the country of export:36478.00.00
Parallel import authorization number:601/12
Date of leaflet approval: 17.10.2022
[Information about the trademark]