Espumisan

Leaflet attached to the packaging: patient information

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

Espumisan (Espumisan L)

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

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 according to the doctor's or pharmacist's instructions.

• 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. 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. 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 agent 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:

• 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 agent 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, 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, 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, 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, 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 use Espumisan

This medicine should always be used in accordance with the leaflet or according to the doctor's instructions. 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 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.
For 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 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 poured through the instrumental channel of the endoscope during the examination to reduce foaming of the gastrointestinal contents.

As an antidote in surfactant (detergent) poisonings:
Adult dosage
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.
Children's dosage
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 swallowing 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.
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.

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, 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 possible side effects not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for the 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 medicine.

5. How to store Espumisan

Store in a place invisible and inaccessible to 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.
There are no special storage precautions.
After the first opening of the packaging, Espumisan remains stable for 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. 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: macrogol stearate, glycerol monostearate 40-55, sorbic acid, sodium hydroxide, sodium chloride, carbomers, sodium citrate, sucralose, 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 glass bottle with a screw cap and dropper, in a cardboard box containing 30 ml of oral drops, emulsion.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the country of export:

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

Manufacturer:

Berlin-Chemie AG (Menarini Group)
Glienicker Weg 125
D-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
Marketing authorization number in Latvia, the country of export:00-0568
Parallel import authorization number:165/17
Date of leaflet approval: 02.09.2022
[Information about the trademark]