Espumisan

Package Leaflet: Information for the User

ESPUMISAN

40 mg, capsules
Simeticone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is ESPUMISAN and what is it used for
• 2. Important information before taking ESPUMISAN
• 3. How to take ESPUMISAN
• 4. Possible side effects
• 5. How to store ESPUMISAN
• 6. Contents of the pack and other information

1. What is ESPUMISAN and what is it used for

ESPUMISAN contains the active substance simeticone, which is used to treat gastrointestinal disorders and as an auxiliary in diagnostic tests.
The active substance of the medicine - simeticone causes the bursting of gas bubbles contained in the food mass and in the mucus of the digestive tract. The gases released in this process can then be absorbed by the intestinal wall and eliminated as a result of intestinal movements.
Simeticone has only a surface effect and does not enter into any chemical reactions. It is a pharmacologically and physiologically inert substance.
Simeticone is not absorbed from the digestive tract after oral administration and is excreted unchanged.
ESPUMISAN is used:

• for the symptomatic treatment of gastrointestinal disorders associated with excessive gas accumulation, such as bloating, feeling of pressure and fullness, belching, rumbling in the intestines;
• in cases of increased gas production in the postoperative period;
• to prepare patients for radiological and ultrasonographic examinations of the abdominal cavity and gastroscopy.

ESPUMISAN is indicated for use in children from 6 years of age, adolescents, and adults.
If you do not feel better or if you feel worse, you should contact your doctor.

2. Important information before taking ESPUMISAN

When not to take ESPUMISAN

• -if you are allergic to simeticone, orange yellow FCF (E 110), methyl parahydroxybenzoate (E 218), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking ESPUMISAN, you should discuss it with your doctor or pharmacist.
In case of new and/or persistent abdominal complaints, you should consult your doctor to determine the cause of the complaints and diagnose any possible disease that requires treatment.

ESPUMISAN and other medicines

No interactions with other medicines are known.

Pregnancy and breastfeeding

Due to the action of simeticone and its lack of absorption from the digestive tract into the body, no harmful effects are expected when taking ESPUMISAN during pregnancy and breastfeeding.
There are no clinical data on the use of ESPUMISAN in pregnant women.

Driving and using machines

ESPUMISAN has no influence or negligible influence on the ability to drive and use machines.

ESPUMISAN contains the dye orange yellow and methyl parahydroxybenzoate.

ESPUMISAN contains the dye orange yellow (E 110) and methyl parahydroxybenzoate.
These substances may cause allergic reactions, in the case of methyl parahydroxybenzoate, probably delayed.

3. How to take ESPUMISAN

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Dosage

Recommended dose:
In gastrointestinal disorders associated with excessive gas accumulation, such as bloating, including cases of increased gas production in the postoperative period:

In preparation for diagnostic tests of the abdominal area, such as radiological, ultrasonographic, and gastroscopic examinations:

Use in children and adolescents

ESPUMISAN is not recommended for children under 6 years of age and infants. Other forms of the medicine are available.

Method of administration

ESPUMISAN can be taken directly before, during, or after meals, and if necessary, also before bedtime.
Note: ESPUMISAN can also be taken in the postoperative period.
ESPUMISAN should be taken as long as symptoms persist. If necessary, ESPUMISAN can be taken for a longer period. See also section 2: "Warnings and precautions".
If you feel that the effect of ESPUMISAN is too strong or too weak, you should talk to your doctor or pharmacist.

Taking a higher dose of ESPUMISAN than recommended

Overdose of ESPUMISAN is practically excluded. Even high doses of the medicine are well tolerated.
The active substance of the medicine - simeticone causes the disappearance of foam in the digestive tract in a purely physical way. Simeticone is not absorbed by the body and does not undergo chemical or biological transformation during passage through the intestines.

Missing a dose of ESPUMISAN

The dose can be taken at any time.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

In the case of medicines containing simeticone, hypersensitivity reactions, including urticaria, rash, redness, itching, allergic dermatitis, and other skin reactions have been reported. The frequency cannot be determined based on available data (frequency unknown).

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store ESPUMISAN

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or label and carton. The expiry date refers to the last day of the specified month.
Do not store this medicine at a temperature above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ESPUMISAN contains

The active substance of ESPUMISAN is simeticone.
Each capsule of ESPUMISAN contains 40 mg of simeticone.
The other ingredients are: methyl parahydroxybenzoate (E 218), gelatin, glycerol 85%, orange yellow FCF (E 110), quinoline yellow (E 104).

What ESPUMISAN looks like and contents of the pack

Soft, yellow, almost round gelatin capsules with a smooth surface and seam.
The contents of the capsules are colorless and may be slightly cloudy.
ESPUMISAN is packaged in 25 or 100 capsules in a cardboard box or 100 capsules in a colorless glass bottle.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01

Date of last revision of the package leaflet: