Espumisan

Package Leaflet: Information for the Patient

Warning!

The leaflet should be kept. Information on the immediate packaging in a foreign language.

Espumisan

Simeticone
40 mg/ml, oral drops, emulsion

Read the leaflet carefully 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact a 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 pack 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 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 by the intestinal wall or removed from the gastrointestinal tract as a result of intestinal peristalsis.
Espumisan is used:

• For the 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 preparing for abdominal cavity tests, such as radiological and ultrasonographic examinations, and gastroscopy.
• As a defoaming agent in poisonings with surfactants (detergents).

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

2. Important information before using Espumisan

When not to use Espumisan:

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

Warnings and precautions

Before starting to use Espumisan, the patient should discuss it with their doctor or pharmacist.
Espumisan should not be used in infants under 1 month of age.
In case of new and/or persistent gastrointestinal symptoms, the patient should 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.

Using Espumisan with food and drink

While using Espumisan, the patient 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 medicine, the patient should consult their 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 1 ml, which means the medicine is considered "sodium-free".

3. How to use Espumisan

This medicine should always be used as described in the leaflet or as directed by a doctor. In case of doubt, the patient should consult their 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 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 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 100-200 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 poisonings with detergents (surfactants):
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, the patient should immediatelyconsult a doctor!
In case of any doubts or feelings that the effect of Espumisan is too strong or too weak, the patient should consult their 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.

Overdose of Espumisan

No cases of overdose have been reported. 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 excluded. 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 recur.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

No side effects associated with the use of Espumisan have been reported.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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.
Reporting side effects 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 given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

Storage conditions

Do not store above 30°C.
After the first opening of the packaging, the medicine retains its potency for 4 weeks.

6. Contents of the pack 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 pack contains

Milky white emulsion, slightly viscous. Oral drops, emulsion.
Espumisan is available in packs:
A brown glass bottle with a screw cap, dropper, and measuring cup in a cardboard box, containing 30 ml of oral emulsion.
For more detailed information, the patient 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 36478.00.00

Parallel import authorization number: 628/12 Date of approval of the leaflet: 20.10.2022

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