Espumisan

Patient Information Leaflet

Warning! Please 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 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a physician or pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a physician, pharmacist, or nurse. See section 4.
• If there is no improvement or if the patient feels worse, contact a physician.

Table of contents of the leaflet:

1. What Espumisan is and what it is 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 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 contents and is also used as an adjunct in diagnostic procedures.
It can be used in all age groups.
The active substance, simeticone, breaks down gas bubbles present in gastrointestinal contents and mucus. As a result, the released gases can be absorbed through the intestinal wall or expelled from the gastrointestinal tract via intestinal peristalsis.
Espumisan is indicated:

• For 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 there is no improvement or if the patient feels worse, consult a physician.

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 gastrointestinal symptoms occur, consult your doctor to determine the cause and to diagnose any underlying disease responsible for such symptoms.

Espumisan and 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 with milk and/or food, or administered with a spoon before or after breastfeeding.

Pregnancy, breastfeeding, and fertility
Before using 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 doctor.
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 droplet dispenser can be found in the section "Instructions for use".
Recommended dose:
Symptomatic treatment of gastrointestinal discomfort caused by excessive gas accumulation, such as bloating and infantile colic in infants over 1 month of age:

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 continue until symptoms have resolved. If needed, 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 three 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 medium suspension:

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

• In preparation of patients for upper gastrointestinal endoscopy (gastroscopy):

Before endoscopy, administer 4–8 ml (corresponding to 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:
Dosage in adults
Depending on the severity of poisoning, administer 10 to 20 ml (from approximately 1/3 to 2/3 of the content of a 30 ml bottle) of Espumisan.
Dosage in children
Depending on the severity of poisoning, administer 2.5 to 10 ml (from 65 drops to approximately 1/3 of the content of a 30 ml bottle) of Espumisan.
Warning: If Espumisan is used as first aid after ingestion of detergent, immediate medical attention is required!
If you have any doubts or feel that the effect of Espumisan is too strong or too weak, consult your doctor 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) contains 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 chemically and physiologically inert substance that is not absorbed from the gastrointestinal tract; therefore, the possibility of poisoning is practically excluded. 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 doctor or pharmacist.

4. Possible adverse reactions

To date, no adverse reactions related to the use of Espumisan have been reported.
Reporting of adverse reactions
If any adverse reactions occur, including any undesirable symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also 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 provide more information on the safety of the medicine.

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 stated month.
No special storage conditions are required.
After first opening, the medicine 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: polyoxyethylene stearate, glycerol monostearate 40-55, carbomers, sucralose, sodium chloride, sodium citrate, sodium hydroxide, sorbic acid, purified water.

What Espumisan looks like and contents of the pack
A milky white to slightly yellowish emulsion, slightly sticky. Oral drops, emulsion.
Pack: a 30 ml amber glass bottle with a PP cap and a PE dropper, contained in a cardboard box, containing 30 ml of oral emulsion.
For further information, please contact the responsible party or 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Latvia, country of export: 00-0568
Parallel import authorisation number: 410/22