Espumisan L

Leaflet attached to the packaging: patient information

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

Espumisan

40 mg/ml, oral drops, emulsion
Simeticone

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. 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 taking Espumisan
• 3. How to take 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 to treat gastrointestinal disorders, reducing foaming of the gastrointestinal contents and as an auxiliary agent in diagnostic tests.
It can be used in all age groups.
The active substance of the medicine, simeticone, causes the rupture 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:

• For symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, such as bloating, infantile colic in infants over 1 month old.
• As an auxiliary agent in preparing 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 the patient feels worse, they should consult their doctor.

2. Important information before taking Espumisan

When not to take Espumisan

Warnings and precautions

Before starting to take Espumisan, discuss it with your doctor or pharmacist.
Espumisan should not be taken by infants under 1 month old.
In case of new and/or persistent gastrointestinal symptoms, consult a doctor to determine the cause of the symptoms and possible diagnosis of the underlying disease.

Espumisan and other medicines

No interactions with other medicines are known.

Taking Espumisan with food and drink

While taking Espumisan, 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 taking any medicine, 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 medicine contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".

3. How to take Espumisan

This medicine should always be taken according to the leaflet or as directed by a doctor. In case of doubts, 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 bloating and infantile colic in infants over 1 month old:

Note: Espumisan can also be given to patients post-operatively.
Espumisan can be taken during or after a meal, and if necessary, also before bedtime.
Treatment should be continued until symptoms disappear. If necessary, Espumisan can be taken 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 a 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 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 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 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, consult a doctor or pharmacist.

Method of administration

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

Overdose of Espumisan

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.

Missed 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, consult a doctor or pharmacist.

4. Possible side effects

No side effects associated with 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, inform your doctor or pharmacist, or nurse.
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, more information can be collected on the safety of the use of the medicine.
Side effects can also be reported to the marketing authorization holder or parallel importer.

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 given month.
Do not store in the refrigerator. Do not freeze.
After the first opening of the packaging, the medicine retains its stability for a period of 6 months.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Espumisan contains

• The active substance of the medicine is simeticone. 1 ml (25 drops) of oral drops, emulsion contains 40 mg of simeticone.
• The other ingredients are: macrogol stearate, glycerol monostearate 40-55, sodium hydroxide, sodium chloride, carbomers, sodium citrate, sucralose, sorbic acid, purified water.

What Espumisan looks like and what the package contains

Milky white to yellowish emulsion, slightly viscous. Oral drops, emulsion.
Packaging: 30 ml brown glass bottle with a dropper made of PE and a cap with a PP ring, in a cardboard box.

Marketing authorization holder in Bulgaria, the country of export:

Berlin-Chemie AG (Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer:

Berlin-Chemie AG (Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35/37
87-100 Toruń
Marketing authorization number in Bulgaria, the country of export:20000194

Parallel import authorization number: 59/23 Date of approval of the leaflet: 30.03.2023

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