Espumisan

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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 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.

• 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 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 tract 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 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 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 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, the patient should discuss it with their doctor or pharmacist.
Espumisan should not be taken by infants under 1 month of age.
In the event of new and/or persistent gastrointestinal symptoms, the patient should consult their 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

During treatment with 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 the bottle with milk or food, or given on a spoon before or after breastfeeding.

Pregnancy, breastfeeding, and fertility

Before taking 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 ml, which means it is considered "sodium-free".

3. How to take Espumisan

This medicine should always be taken as described in the leaflet or as advised by a doctor. In case of doubts, 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 taken for a longer period.
For 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):

Prior to 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 tract contents.
As an antidote in detergent (surface-active substance) poisonings:
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, 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.
Dosing 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 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 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 treatment with 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 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, 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 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.
No special storage precautions are required.
After the first opening of the packaging, the medicine retains its potency for 6 months.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their 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 stearate, glycerol monostearate 40-55, carbomers, sucralose, sodium chloride, sodium citrate, sodium hydroxide, 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 glass bottle with a PP cap and a PE dropper, in a cardboard box, containing 30 ml of oral drops, emulsion.
For more detailed information, the patient should contact the marketing authorization holder or the 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:

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
Marketing authorization number in Latvia, the country of export: 00-0568

Parallel import authorization number: 410/22 Date of approval of the leaflet: 22.11.2022

[Information about the trademark]