ESPUMISAN

Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Espumisan (Espumisan L)
40 mg/ml, oral drops, emulsion
Simeticonum
Espumisan and Espumisan L are different brand names for the same medicine.
Please read the entire 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 patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your doctor.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms persist or worsen, contact your doctor.

Table of contents of the leaflet

1. What Espumisan is and what it is used for
2. Important information before taking Espumisan
3. How to take Espumisan
4. Possible side effects
5. How to store Espumisan
6. Contents of the pack and other information

1. What Espumisan is and what it is used for

Espumisan contains the active substance simeticone, which is an agent used in gastrointestinal disorders to reduce foaming in the gastrointestinal tract and is also used as an adjunct in diagnostic procedures.
It can be used in all age groups.
The active substance of the medicine, simeticone, causes the breakdown of gas bubbles present in gastrointestinal contents and mucus. As a result, the released gases can be absorbed through the intestinal wall or eliminated from the gastrointestinal tract via intestinal peristalsis.
Espumisan is indicated for:

• Symptomatic treatment of gastrointestinal disturbances associated with excessive gas accumulation, such as bloating, infantile colic in infants over 1 month of age.
• Adjunctive use in preparation for abdominal examinations, such as radiological and ultrasonographic examinations and gastroscopy.
• As an agent reducing foaming in poisoning with surface-active agents (detergents).

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

2. Important information before using Espumisan

When not to use Espumisan

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

Warnings and precautions
Before starting to use Espumisan, consult your doctor or pharmacist.
Espumisan should not be used in infants during the first month of life.
If new and/or persistent abdominal symptoms occur, consult a doctor to determine the cause and diagnose any possible underlying condition requiring 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 during pregnancy and breastfeeding.

Driving and operating machinery
No special precautions are required.

Espumisan contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per ml; therefore, the medicine is considered "sodium-free".

3. How to use Espumisan

This medicine should always be taken according to the instructions in the leaflet or as recommended by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Dosage
Recommended dose:
Symptomatic treatment of gastrointestinal complaints associated with excessive
accumulation of gas

• e.g. bloating, infantile colic :

Warning: Espumisan may also be administered to patients in the postoperative period.
Espumisan may be taken directly before, during, or after a meal, and, if necessary, also before bedtime.
Treatment should continue until symptoms have resolved. If necessary, Espumisan may be administered for a prolonged period.
In preparation for diagnostic examinations of the abdominal cavity:

• Radiological and ultrasonographic examination:

• As an excipient administered together with the contrast medium suspension:

4 - 8 ml ( ≙ 100 - 200 drops) per 1 liter of contrast fluid used in double-contrast examinations.

• In patient preparation for upper gastrointestinal endoscopy (gastroscopy):

Before endoscopy: 4 - 8 ml ( ≙ 100 - 200 drops).
If necessary, additional milliliters of the emulsion may be instilled during the procedure through the endoscope's instrument channel to reduce foaming of gastrointestinal contents.

• As an antidote in detergent (surface-active agent) poisoning:

Depending on the severity of poisoning:

Warning: If Espumisan medicine is used as first aid after ingestion of detergent,
you must immediately consult a doctor!
Instructions for use
Shake well before use.
To measure the correct number of drops, hold the bottle vertically with the opening facing downwards.
25 drops (1 ml of oral drops, emulsion) contains 40 mg of simethicone.
Since Espumisan medicine does not contain sugar, it can also be administered to patients
with diabetes and patients with nutritional disorders.
Use of a higher than recommended dose of Espumisan medicine
No cases of poisoning following the use of Espumisan medicine have been reported so far.
The active substance in Espumisan medicine – simethicone – eliminates foam in the gastrointestinal tract
in a purely physical manner and is biologically and chemically completely
inactive.
Therefore, the possibility of poisoning can practically be ruled out. Even large doses of Espumisan medicine are
well tolerated.
Missed dose of Espumisan medicine
In such a case, the missed dose can be taken at any time.
Discontinuation of Espumisan medicine
In such a case, symptoms may recur.
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

In medicinal products containing simethicone, hypersensitivity reactions have been reported, including urticaria,
rash, skin redness, itching, allergic dermatitis and other skin reactions. The frequency cannot be estimated
from the available data (frequency unknown).
Other adverse reactions have also been reported; however, since the medicinal product is practically not absorbed
from the gastrointestinal tract, adverse reactions are very rare.
Reporting of adverse reactions
If any adverse reactions occur, including any undesirable effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Espumisan

Keep this medicine 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 stated month.
Note on shelf-life after first opening: after first opening, the medicine Espumisan remains stable for 6 months.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What the medicine Espumisan contains
The active substance is simethicone.
25 drops (1 ml of oral drops, emulsion) contain 40 mg of simethicone.
The other ingredients are: polyoxyethylene stearate, glycerol monostearate 40-55, sodium hydroxide,
sodium chloride, carbomers, sodium citrate, sucralose, sorbic acid, purified water.

What the medicine Espumisan looks like and contents of the pack
Milk-white to yellowish emulsion, slightly sticky. Oral drops, emulsion.
Pack: 30 ml amber glass bottle with PP cap and PE dropper, in a cardboard box, containing 30 ml of oral drops, emulsion.

For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Latvia, country of export:
Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany

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

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in Latvia, country of export: 00-0568
Parallel import authorisation number: 77/25