Patient Information Leaflet

Warning! Keep this 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 of the same medicine.
Please read this 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 doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your doctor or pharmacist.
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, consult your doctor.

Table of contents:

What Espumisan is and what it is used for
Important information before taking Espumisan
How to take Espumisan
Possible side effects
How to store Espumisan
Contents of the pack and other information

1. What Espumisan is and what it is used for

Espumisan contains the active substance simethicone, which is an agent used in gastrointestinal disorders to reduce foaming in the gastrointestinal tract and is also used as an adjunct in diagnostic examinations.
It can be used in all age groups.
The active substance in this medicine, simethicone, breaks down 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 the symptomatic treatment of gastrointestinal disturbances associated with excessive gas accumulation, such as bloating, infant colic in infants over 1 month of age.
As an adjunct 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 symptoms do not improve or worsen, consult your 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 must not be used in infants during the first month of life.
If new and/or persistent gastrointestinal symptoms occur, consult your doctor to determine the cause and to diagnose any underlying disease causing these symptoms.

Espumisan with other medicines
No interactions with other medicines are known.

Taking Espumisan with food and drink
During treatment with Espumisan, avoid consuming carbonated beverages. Espumisan may be taken directly before, during, or after meals, and if necessary, also before bedtime.

Infants
Espumisan should be added to the bottle of milk and/or food, or administered with a spoon before or after breastfeeding.

Pregnancy, breastfeeding and fertility
Before taking any medicine, consult your doctor or pharmacist.
There are no restrictions on the use of Espumisan in pregnant or breastfeeding women.

Driving and operating machinery
No special precautions are required.

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

3. How to use Espumisan

This medicine should always be used according to the instructions in the leaflet or as directed by a physician.
If in doubt, consult a doctor or pharmacist.
Dosage
The dose can be measured using the dropper.
More detailed information on how to use the dropper can be found in the section
"How to use".
Recommended dose:
Symptomatic treatment of gastrointestinal discomfort associated with excessive gas accumulation, such as bloating and infantile colic in infants over 1 month of age:

Age group	Dosage
Infants over 1 month of age	1 - 2 ml (25 – 50 drops), corresponding to 40 – 80 mg of simethicone per day, divided into 2 (2 times daily, 13 – 25 drops) to 4 (4 times daily, 6 –
	13 drops) divided doses; the total daily dose should not exceed 80 mg; Espumisan should be added to the milk bottle or administered with a spoon before or after breastfeeding.
Children from 1 to 6 years of age	1 ml (25 drops), corresponding to 40 mg of simethicone, 3 to 5 times daily.
Children from 6 to 14 years of age	1 ml – 2 ml (25 – 50 drops), corresponding to 40 – 80 mg of simethicone, 3 to 5 times daily.
Adolescents and adults	2 ml (50 drops), corresponding to 80 mg of simethicone, 3 to 5 times daily.

Warning: Espumisan may also be administered to patients in the postoperative period.
Espumisan may be taken during or after meals, and, if necessary, also before bedtime.
Treatment should be continued until symptoms subside. If required, Espumisan may be administered for a prolonged period.

In preparation for diagnostic examinations of the abdominal cavity:

Radiological and ultrasonographic examinations:

2 ml (50 drops) of Espumisan 3 times daily 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 suspension:

For double-contrast imaging examinations, 4 to 8 ml (100 to 200 drops) of Espumisan per 1 liter of contrast fluid is used.

In preparing patients for upper gastrointestinal endoscopy (gastroscopy):
Before endoscopy, 4–8 ml (equivalent to 100 to 200 drops). If necessary, additional milliliters of the emulsion may be administered through the instrument channel of the endoscope during the procedure to reduce foaming of gastrointestinal contents.

As an antidote in detergent poisoning (surfactant agents):
Dosage in adults
Depending on the severity of poisoning, 10 to 20 ml (from approximately 1/3 to 2/3 of the content of a 30 ml bottle) of Espumisan should be administered.
Dosage in children
Depending on the severity of poisoning, 2.5 to 10 ml (from 65 drops to approximately 1/3 of the content of a 30 ml bottle) of Espumisan should be administered.
Warning: If Espumisan is used as first aid after ingestion of a detergent, immediate medical attention is required!
In case of any doubts or if the effect of Espumisan seems too strong or too weak, consult a physician or pharmacist.

Method of administration
Shake well before use.
Dosage using the dropper:
To measure the correct number of drops, hold the bottle vertically with the opening facing downwards.
25 drops (1 ml of oral drops, emulsion) contain 40 mg of simethicone.

Use of a higher than recommended dose of Espumisan
No cases of overdose have been reported to date.
Simethicone is a substance that is chemically and physiologically completely inert and is not absorbed from the gastrointestinal tract; therefore, intoxication is practically impossible. Even large doses of Espumisan are well tolerated.

Missed dose of Espumisan
In such a case, the missed dose may be taken at any time.

Discontinuation of Espumisan
In such a case, symptoms may recur.

If you have any further doubts regarding the use of this medicinal product, consult your physician or pharmacist.

4. Possible adverse reactions

No adverse reactions related to the use of Espumisan have been reported to date.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Reporting adverse reactions helps to provide more information on the safety of this medicinal product.

5. How to store Espumisan

Keep the 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 specified month.
No special storage conditions are required.
After first opening, Espumisan remains stable for 6 months.
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 pack and other information

What Espumisan contains

The active substance in Espumisan is simethicone. 1 ml (25 drops) of oral emulsion contains 40 mg of simethicone.

The other ingredients are: polyoxyl stearate, glycerol monostearate 40-55, sorbic acid,
sodium hydroxide, sodium chloride, carbomers, sodium citrate, sucralose, purified water.
What Espumisan looks like and contents of the pack
A milky white to yellowish emulsion, slightly sticky. Oral drops, emulsion.
Espumisan is available in a 30 ml amber glass bottle with a screw cap and dropper,
contained in a cardboard box with 30 ml of oral emulsion.
For more detailed 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
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
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation number in Latvia, country of export: 00-0568
Parallel import licence number: 165/17