ESPUMISAN

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Espumisan (Espumisan Emulsion)
40 mg/ml, oral drops, emulsion
Simeticonum
Espumisan and Espumisan Emulsion are different trade names for the same medicinal product.
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 the patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet, so you can read it again if necessary.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If your symptoms do not improve or worsen, consult your doctor.

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 and as an adjunct in diagnostic procedures.
It can be used in all age groups.
The active substance in Espumisan, 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 eliminated from the gastrointestinal tract via intestinal peristalsis.
Espumisan is used:

• For symptomatic treatment of gastrointestinal disturbances associated with excessive gas accumulation, such as bloating, infantile 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 to reduce foaming in poisoning with surface-active agents (detergents).

If there is no improvement or if the patient feels worse, medical advice should be sought.

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 a doctor to determine the cause of the symptoms and to diagnose any underlying disease responsible for these symptoms.

Espumisan and other medicines
No interactions with other medicines are known.
Taking Espumisan with food and drink
Avoid consuming carbonated beverages while using Espumisan. 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 using any medicine, consult your doctor or pharmacist.
There are no restrictions on the use of Espumisan in women who are pregnant or 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 used according to the instructions in the leaflet or as directed by a physician.
In case of doubt, consult a doctor or pharmacist.
Dosage
The dose can be measured using the dropper provided.
More detailed information on how to use the dro游戏副本

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 necessary, Espumisan may be administered for a prolonged period.

Preparation for abdominal diagnostic examinations:

• 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, 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): 4–8 ml (equivalent to 100 to 200 drops) before endoscopy. If necessary, additional milliliters of the emulsion may be instilled through the endoscope's instrument channel during the procedure to reduce foaming in the gastrointestinal tract.

As an antidote in detergent (surface-active agent) poisoning:
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 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 downward.
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 chemically and physiologically inert substance that is not absorbed from the gastrointestinal tract; therefore, poisoning 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 treatment
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

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 adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. 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
Reporting adverse reactions enables the collection of further information on the safety of the medicine.

5. How to store Espumisan

Keep the medicine out of the 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.
Do not store above 30 °C.
After first opening, Espumisan remains stable for a period of 4 weeks.
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 packaging 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 1500, glyceryl monostearate, sorbic acid,
hydroxypropylcellulose, sodium cyclamate, sodium saccharin, purified water.

What Espumisan looks like and contents of the pack
A milky white to slightly yellowish emulsion, slightly viscous. Oral drops, emulsion.
Packaging: amber glass bottle with a screw cap and dropper, in a cardboard box,
containing 30 ml of oral emulsion.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Manufacturer:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

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

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

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa

SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation number in Germany, the country of export: 36478.00.00
Parallel import licence number: 425/22