Espumisan

LEAFLET ATTACHED TO THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is 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.

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 advised 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 tell their doctor, 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 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 through 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 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 of age.
In case of new and/or persistent gastrointestinal symptoms, consult a 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.

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 and/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 in accordance with the leaflet or as advised by a doctor. In case of doubt, 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 post-operatively.
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 taken 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 upper gastrointestinal endoscopy (gastroscopy):Before endoscopy, 4-8 ml (corresponding to 100 to 200 drops). If necessary, a few milliliters 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 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.
Dosage 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.

Taking 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, 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 this leaflet, tell your doctor, 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.

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 opening the packaging, Espumisan remains stable for 4 weeks.
Medicines should not be disposed of via wastewater or household waste. 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 Espumisan is simeticone.
1 ml (25 drops) of oral drops, emulsion contains 40 mg of simeticone.
The other ingredients of the medicine are: macrogol 1500 stearate, glycerol monostearate, sorbic acid, hydroxypropyl cellulose, sodium cyclamate, sodium saccharin, purified water.

What Espumisan looks like and what the packaging contains

Milky white to yellowish emulsion, slightly viscous. Oral drops, emulsion.
Packaging: orange glass bottle with a screw cap and dropper, in a cardboard box, containing 30 ml of oral drops, emulsion.
To obtain more detailed information, consult 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Germany, the country of export: 36478.00.00
Parallel import authorization number: 425/22
Date of leaflet approval: 09.12.2022
[Information about the trademark]