Espumisan

Package leaflet: Information for the user

ESPUMISAN
40 mg, capsules
Simeticonum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

1. What ESPUMISAN is and what it is 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 ESPUMISAN is and what it is used for

ESPUMISAN contains the active substance simeticone, which is an agent used in gastrointestinal disorders and as an adjunct in diagnostic examinations.
The active substance of the medicine – simeticone – causes the breakdown of gas bubbles present in the intestinal contents and mucus of the gastrointestinal tract. The gases released in this process can then be absorbed through the intestinal wall and eliminated via intestinal movements.
Simeticone exerts only a surface effect and does not participate in any chemical reactions. It is pharmacologically and physiologically inert.
Simeticone is not absorbed from the gastrointestinal tract following oral administration and is excreted unchanged.
ESPUMISAN is indicated for use:

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

ESPUMISAN is indicated for use in children from 6 years of age, adolescents, and adults.
If there is no improvement or if you feel worse, consult your doctor.

2. Important information before using the medicine ESPUMISAN

When not to use ESPUMISAN

• if the patient is allergic to simethicone, sunset 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 starting to use ESPUMISAN, discuss it with your doctor or pharmacist.
If new and/or persistent abdominal symptoms occur, consult a doctor to determine the cause and diagnose any possible illness requiring treatment.

ESPUMISAN with other medicines
No interactions with other medicines are known.

Pregnancy and breastfeeding
Due to the mechanism of action of simethicone and its lack of absorption from the gastrointestinal tract into the body, harmful effects of using ESPUMISAN during pregnancy and breastfeeding are not expected.
However, there are no clinical data on the use of ESPUMISAN in pregnant women.

Driving and operating machinery
ESPUMISAN has no effect or has a negligible effect on the ability to drive and operate machinery.

ESPUMISAN contains the colour sunset yellow FCF and methyl parahydroxybenzoate.
ESPUMISAN contains the colour sunset yellow FCF (E 110) and methyl parahydroxybenzoate.
These substances may cause allergic reactions; in the case of methyl parahydroxybenzoate, the reactions are probably delayed.

3. How to use ESPUMISAN

This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Dosage
Recommended dose:
For gastrointestinal disorders associated with excessive accumulation of gas, e.g. bloating, including increased gas formation in the postoperative period:

In preparation for diagnostic examinations of the abdominal area, e.g. radiological,
ultrasonographic and gastroscopic procedures:

Use in children and adolescents
ESPUMISAN is not recommended for children under 6 years of age and infants. Other dosage forms are available.
Method of administration
ESPUMISAN may be taken directly before, during, or after meals, and if necessary, also before bedtime.
Note: ESPUMISAN may also be used in the postoperative period.
ESPUMISAN should be taken as long as symptoms persist. If necessary, ESPUMISAN may be used for a prolonged period. See also section 2: "Warnings and precautions".
If the patient feels that the effect of ESPUMISAN is too strong or too weak, they should consult their doctor or pharmacist.
Use of a higher than recommended dose of ESPUMISAN
Poisoning due to overdose of ESPUMISAN is practically impossible. Even large doses of the medicine are well tolerated.
The active substance of the medicine – simethicone – eliminates foam in the gastrointestinal tract through a purely physical mechanism. Simethicone is not absorbed by the body and does not undergo chemical or biological transformation while passing through the intestines.
Missed dose of ESPUMISAN
A missed dose can be taken at any time.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

With medications 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 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 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ESPUMISAN medicine

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, label, or carton. The expiry date refers to the last day of the stated month.
Do not store this medicine above 30°C.
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.
Each ESPUMISAN capsule contains 40 mg of simethicone.
Other ingredients are: methyl parahydroxybenzoate (E 218), gelatin, glycerol 85%, yellow
FCF (E 110), quinoline yellow (E 104).
What ESPUMISAN looks like and contents of the pack
Soft, nearly round, yellow, gelatin capsules with a smooth surface and a seam.
The capsule contents are colourless and may be slightly cloudy.
ESPUMISAN is packed in cardboard boxes containing 25 or 100 capsules, or in a colourless glass bottle containing 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00
Fax: +48 22 566 21 01