Espumisan 100 mg/ml

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Espumisan 100 mg/ml
100 mg/ml oral drops, emulsion
Simeticonum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents:

1. What is Espumisan 100 mg/ml and what is it used for?
2. Important information before using Espumisan 100 mg/ml
3. How to use Espumisan 100 mg/ml
4. Possible side effects
5. How to store Espumisan 100 mg/ml
6. Contents of the pack and other information

1. What is Espumisan 100 mg/ml and what is it used for?

This medicine is used for the symptomatic treatment of bloating (accumulation of gas) in all age groups. It reduces the surface tension of gas bubbles present in gastrointestinal contents and mucus, causing them to break. As a result, the released gases can be absorbed through the intestinal wall or eliminated from the gastrointestinal tract via intestinal peristalsis.
Indications
Espumisan 100 mg/ml is indicated:
Without consulting a doctor:

• for the symptomatic treatment of gastrointestinal disturbances associated with excessive gas accumulation, such as bloating or increased gas formation in the gastrointestinal tract;

After consulting a doctor:

• for the symptomatic treatment of gastrointestinal disturbances associated with excessive gas accumulation, e.g. increased gas formation in the gastrointestinal tract in the postoperative period;
• as an adjunct in patient preparation for abdominal examinations (e.g. radiological and ultrasonographic examinations, and endoscopic procedures, as an additive to the contrast medium suspension).

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Espumisan 100 mg/ml

When not to take Espumisan 100 mg/ml:

• If the patient is allergic to simethicone or any of the other ingredients of this medicine (listed in section 6).
• This should also be kept in mind when administering the medicine to other individuals.

Warnings and precautions
Before starting to take Espumisan 100 mg/ml, discuss this with your doctor or
pharmacist.
If new symptoms occur, a visit to the doctor is necessary. Do not take this medicine for longer than 14 days without consulting a doctor. If symptoms persist during this time, consult your doctor.
Children and adolescents
When using this medicine in infants and children, consult a doctor.
Espumisan 100 mg/ml and other medicines
No interactions with other medicines are known.
Espumisan 100 mg/ml with food and drink
No special requirements.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Due to the lack of clinical studies on the use of this medicine during pregnancy, its use is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
No special precautions are required.
Espumisan 100 mg/ml contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml; therefore, the medicine is considered "sodium-free".

3. How to use Espumisan 100 mg/ml

This medicine should always be used exactly as described in this patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The dose of Espumisan 100 mg/ml can be measured in two ways.
Depending on the size of the dose, it can be measured using:

• a dropper,
• a measuring device marked in ml. Detailed instructions on measuring doses are provided below.

Dosage
The dose should be adjusted according to the severity of symptoms.
Recommended dose:
Without consulting a doctor, for gastrointestinal discomfort associated with excessive
accumulation of gas in the digestive tract.

This medicine may also be administered to patients in the postoperative period after consultation with a physician.
This medicine may be taken directly before, during, or after meals, if necessary,
including before bedtime.
Treatment should continue until symptoms resolve, but not longer than 14 days without
consultation with a physician.
This medicine may be administered for a prolonged period only upon physician's recommendation. See also section 2:
"Warnings and precautions".
Prior to diagnostic examinations of the abdominal cavity, as directed by the physician.
Dosage in ml (using the measuring device)
1 ml three times daily the day before examination, after meals, and 1 ml in the morning on the day of examination
As an additive to contrast medium suspension, after consultation with the physician.
Dosage in ml (using the measuring device)
2 ml to 4 ml per 1 liter of contrast medium used during double-contrast examination
Prior to stomach and small intestine examination (endoscopy), after consultation with the physician.
Dosage in ml (using the measuring device)
2 to 3 ml before examination
If necessary, additional milliliters of the emulsion may be instilled through the endoscope during the procedure to reduce foaming in the gastrointestinal tract.
Method of administration
Shake well before use!
Use of the dropper (10–25 drops)
To measure the appropriate number of drops, hold the bottle vertically with the opening pointing downward.
25 drops correspond to 1 ml of emulsion (equivalent to 100 mg of simethicone).
Use of the measuring device
For accurate dosing, a measuring device marked in ml is provided in the package, attached to the cap of the 30 ml and 50 ml bottles. If necessary (e.g., to administer a dose exceeding 25 drops), the measuring device may be detached and used instead of the dropper.
Warning: Due to the risk of swallowing, the measuring device should be stored out of reach of children.
Overdose of Espumisan 100 mg/ml
Ingestion of a larger than recommended dose of Espumisan 100 mg/ml is not expected to cause poisoning. Even large doses of this medicine are well tolerated. The active substance, simethicone, reduces gastrointestinal gas bubbles purely through physical action. Simethicone is not absorbed and undergoes no chemical or enzymatic transformation in the gastrointestinal tract.
Missed dose of Espumisan 100 mg/ml
A missed dose may be taken at any time.
Discontinuation of Espumisan 100 mg/ml
After stopping the medicine, symptoms may recur.
If you have any further doubts concerning the use of this medicine, consult your physician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With medicines containing simethicone, hypersensitivity reactions have been reported, including urticaria,
rash, skin redness, itching, allergic dermatitis and other skin reactions. The frequency cannot be
determined from the available data (frequency unknown).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Side effects can also be reported directly to the Department of Monitoring of 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
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Espumisan 100 mg/ml

Keep this 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.
There are no special temperature storage requirements. Do not store in a refrigerator or freeze.
This medicine can be used for 6 months after first opening the container.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Espumisan 100 mg/ml contains
The active substance in Espumisan 100 mg/ml is simethicone.
1 ml of oral emulsion contains 100 mg of simethicone.
Other ingredients are:
Polysorbate 60, glycerol monostearate 40-55, sorbic acid (E 200), sodium hydroxide (E 524), sodium chloride, carbomers, sodium citrate (E 331), sucralose (E 955), purified water.

What Espumisan 100 mg/ml looks like and contents of the pack
Espumisan 100 mg/ml is a milky white to slightly yellowish, low-viscosity emulsion in 30 ml and 50 ml amber glass bottles, with a dropper, screw cap with tamper-evident ring, and a dosing spoon, packed in a cardboard box.
A characteristic feature of this product is a gradual yellowing of the emulsion over time.

For further information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Romania, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation number in Romania, country of export: 8749/2016/01
8749/2016/02
Parallel Import Licence number: 59/15

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Bulgaria Еспумизан комфорт 100 mg/ml перорални капки, емулсия
Czech Republic Espumisan
Estonia Espumisan 100 mg/ml
Hungary Espumisan 100 mg/ml belsőleges emulziós cseppek
Latvia Espumisan 100 mg/ml pilieni iekšķīgai lietošanai, emulsija
Poland Espumisan 100 mg/ml
Romania Espumisan 100 mg/ml, picături orale, emulsie
Slovenia Espumisan 100 mg/ml, peroralne kapljice, emulzija
Slovakia Espumisan comfort 100 mg/ml perorálne emulzné kvapky