Espumisan

Package Leaflet: Information for the Patient

Espumisan

40 mg/ml, oral drops, emulsion
Simeticone

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

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your doctor.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package 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 package 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 disappearance of gas bubbles contained in the gastrointestinal masses and in the mucus of the gastrointestinal tract. This allows the released gases 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, for example: 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 you do not feel better or if you feel worse, you should contact your doctor.

2. Important information before using Espumisan

When not to use Espumisan

Warnings and precautions

Before starting to use Espumisan, you should discuss it with your doctor or pharmacist.
Espumisan should not be used in infants under 1 month of age.
In case of new and/or persistent abdominal complaints, you should consult a doctor to determine the cause of the complaints and diagnose any underlying disease that may require treatment.

Espumisan and other medicines

No interactions with other medicines are known.

Pregnancy, breastfeeding, and fertility

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 that the medicine is considered "sodium-free".

3. How to use Espumisan

This medicine should always be used in accordance with the package leaflet or as directed by your doctor or pharmacist.
In case of doubt, you should consult your doctor or pharmacist.

Dosage

Recommended dose:
Symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation

• e.g., bloating, infantile colic:

Note: Espumisan can also be given to patients in the postoperative period.
Espumisan can be taken directly before a meal, during, or after a meal, and if necessary, also before bedtime.
Treatment should be continued until symptoms disappear. If necessary, Espumisan can be administered for a longer period.
In preparation for diagnostic tests of the abdominal cavity

• Radiological and ultrasonographic examination:

• As an auxiliary substance administered together with the contrast agent suspension:
• 4 - 8 ml (≈ 100 - 200 drops) per 1 liter of contrast agent used during the double-contrast examination.
• In preparing patients for upper gastrointestinal endoscopy (gastroscopy):

Before endoscopy, 4 - 8 ml (≈ 100 - 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 poisonings with detergents (surfactants):
Depending on the severity of poisoning:
Note: If Espumisan is used as a first-aid measure after ingestion of a detergent, you should immediatelyconsult a doctor!

Method of administration

Shake before use.
To measure the correct number of drops, the bottle should be held vertically, with the opening facing downwards.
25 drops (1 ml of oral drops, emulsion) contain 40 mg of simeticone.
Since Espumisan does not contain sugar, it can also be administered to diabetic patients and patients with dietary disorders.

Use of a higher than recommended dose of Espumisan

No cases of poisoning have been reported after using Espumisan.
The active substance of Espumisan, simeticone, causes the disappearance of foam in the gastrointestinal tract in a purely physical way and is biologically and chemically completely inactive.
Therefore, the possibility of poisoning can be practically excluded. 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 recur.
In case of any further doubts regarding the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

In the case of medicines containing simeticone, hypersensitivity reactions, including urticaria, rash, skin redness, itching, allergic skin inflammation, and other skin reactions have been reported. The frequency cannot be estimated from the available data (frequency unknown).
Other side effects have also been reported, but since the medicinal product is practically not absorbed from the gastrointestinal tract, side effects are very rare.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should tell your doctor or pharmacist. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Espumisan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging after the abbreviation EXP. The expiry date refers to the last day of the given month.
Note regarding shelf life after first opening: after the first opening of the package, Espumisan retains its shelf life for a period of 6 months.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Espumisan contains

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

What Espumisan looks like and what the package contains

Milky white to yellowish emulsion, slightly viscous. Oral drops, emulsion.
Package: 30 ml glass bottle with a child-resistant closure, with a screw cap and dropper, in a cardboard box, containing 30 ml of oral drops, emulsion.

Marketing authorization holder and manufacturer

BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Berlin-Chemie / Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01

Date of the last update of the package leaflet: