Espumisan l
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Espumisan
40 mg/ml, oral drops, emulsion
Simeticonum
Please read carefully the entire leaflet before using this 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, please consult a physician or pharmacist.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a physician, pharmacist, or nurse. See section 4.
- If symptoms do not improve or worsen, contact a physician.
Table of contents
- What Espumisan is and what it is used for
- Important information before using Espumisan
- How to use Espumisan
- Possible side effects
- How to store Espumisan
- Contents of the package 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 examinations.
It may be used in all age groups.
The active substance in 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 the 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 reducing foaming in poisoning with surface-active agents (detergents).
If there is no improvement or if the patient feels worse, consult a physician.
2. 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 discomfort occurs, consult a doctor to determine the cause of symptoms and to diagnose any underlying disease causing them.
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 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
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 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 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 in 2 (2 times daily, 13 - 25 drops each time) to 4 divided doses (4 times daily, 6 - 13 drops each time); total daily dose not exceeding 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 | 1 ml (25 drops), corresponding to 40 mg of simethicone, 3 to 5 times daily. |
| Children from 6 to 14 years | 1 - 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, before bedtime as well.
Treatment should continue until symptoms have resolved. If necessary, Espumisan may be administered for a prolonged period.
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 suspension: For double-contrast imaging examinations, 4 to 8 ml (100 to 200 drops) of Espumisan per 1 liter of contrast fluid should be used.
- In preparation for upper gastrointestinal endoscopy (gastroscopy): 4–8 ml (corresponding to 100–200 drops) of Espumisan before endoscopy. If necessary, additional milliliters of the emulsion may be administered 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 appears too strong or too weak, consult a physician or pharmacist.
Instructions for use
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 chemically and physiologically inert substance that is not absorbed from the gastrointestinal tract; therefore, intoxication is practically impossible. Even large doses of Espumisan are well tolerated.
Missed dose of Espumisan
If a dose has been missed, it may be taken at any time.
Discontinuation of Espumisan
In such a case, symptoms may recur.
If you have any further questions regarding the use of this medicinal product, please consult your physician 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 a doctor, pharmacist, or nurse.
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 gather further information on the safety of the medicine.
Adverse reactions may also be reported to the responsible entity or the parallel importer.
5. How to store Espumisan
Keep 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 in a refrigerator. Do not freeze.
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 package and other information
What Espumisan contains
- The active substance is simethicone. 1 ml (25 drops) of oral drops, emulsion contains 40 mg of simethicone.
- Other ingredients are: polyoxyethylene stearate, glycerol monostearate 40-55, sodium hydroxide, sodium chloride, carbomers, sodium citrate, sucralose, sorbic acid, purified water.
What Espumisan looks like and contents of the pack
Milk-white to slightly yellowish, slightly viscous emulsion. Oral drops, emulsion.
Pack: 30 ml amber glass bottle with a PE dropper and PP screw cap with tamper-evident ring, in a cardboard box.
Marketing Authorisation Holder in Bulgaria, 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:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
Działkowa 56
02-234 Warsaw
Forteczna 35/37
87-100 Toruń
Poland
Marketing Authorisation Number in Bulgaria, country of export: 20000194
Parallel Import Authorisation Number: 59/23