Espumisan Forte

Package Leaflet: Information for

the user

Espumisan FORTE

240 mg, soft capsules

Simeticonum

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 a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should consult a doctor.

Package Leaflet Contents

• 1. What is Espumisan FORTE and what is it used for
• 2. Important information before taking Espumisan FORTE
• 3. How to take Espumisan FORTE
• 4. Possible side effects
• 5. How to store Espumisan FORTE
• 6. Package contents and other information

1. What is Espumisan FORTE and what is it used for

Espumisan FORTE contains the active substance simeticone, which is used for gastrointestinal disorders and as an auxiliary in diagnostic tests.
The active substance of the medicine, simeticone, causes the breakdown of gas bubbles contained in the food mass and in the mucous membrane of the gastrointestinal tract. The gases released during this process can then be absorbed by the intestinal wall and eliminated as a result of intestinal movements.

Indications for use

For self-medication:

• gastrointestinal disorders associated with excessive gas accumulation, e.g. bloating, feeling of fullness in the abdominal cavity;

On the doctor's advice:

• as an aid in preparing patients for diagnostic tests of the abdominal cavity, such as radiological and ultrasonographic (USG) examinations.

Espumisan FORTE is indicated for use in adolescents from 15 years of age and adults.
Gas-related disorders may also be a sign of functional disorders in the gastrointestinal tract and may manifest as a feeling of pressure and fullness in the abdominal cavity, premature feeling of overeating, belching, rumbling in the intestines, and bloating.
If there is no improvement after 3 days or the patient feels worse, they should consult a doctor.

2. Important information before taking Espumisan FORTE

When not to take Espumisan FORTE

• -if the patient is allergic to simeticone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Espumisan FORTE, the patient should discuss it with their doctor or pharmacist.
In case of new or persistent abdominal disorders for 3 days, the patient should consult their doctor to determine the cause of the disorder and diagnose any underlying disease that may require treatment.

Espumisan FORTE and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other medicines are known. Due to the surface-active properties of simeticone, pharmacokinetic interactions cannot be ruled out.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There are no data on the use of simeticone in pregnant women. Animal studies are insufficient to assess the toxic effect on reproduction. No effect on pregnancy is expected, as the systemic exposure to simeticone is negligible.
Breastfeeding
No effect on newborns/infants is expected, as the systemic exposure of the breastfeeding mother to simeticone is negligible.

Driving and using machines

Espumisan FORTE has no influence or insignificant influence on the ability to drive and use machines.

3. How to take Espumisan FORTE

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Dosage

Recommended dose for adolescents from 15 years of age and adults:
In self-medication for gastrointestinal disorders associated with excessive gas accumulation, e.g. bloating, feeling of fullness in the abdominal cavity
The patient should take one capsule of Espumisan FORTE after each main meal (lunch and dinner). The dose should not exceed the maximum dose of 3 capsules per day.
On the doctor's advice as an aid in preparing for diagnostic tests of the abdominal cavity, e.g. radiological and ultrasonographic (USG) examinations:
One capsule of Espumisan FORTE per day before the examination.

Patients with liver or kidney disorders

No dose adjustment is necessary.

Patients in advanced age

There are no specific data comparing the use of simeticone in elderly patients with its use in other age groups.

Use in children

The use of Espumisan FORTE is not recommended in infants and children under 15 years of age.

Method of administration

Espumisan FORTE should be taken after main meals, with a glass of water.
Espumisan FORTE should be taken as long as symptoms persist. If necessary, Espumisan FORTE can be taken for 30 days. See also section 2: "Warnings and precautions".
If the patient feels that the effect of Espumisan FORTE is too strong or too weak, they should talk to their doctor or pharmacist.

Overdose of Espumisan FORTE

Overdose of Espumisan FORTE is practically excluded. Even large doses of the medicine are well tolerated.
The active substance of the medicine, simeticone, causes the breakdown of foam in the gastrointestinal tract in a purely physical way. Simeticone is not absorbed by the body and does not undergo chemical or biological transformation during its passage through the intestines.

Missed dose of Espumisan FORTE

The dose can be taken at any time.
A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Espumisan FORTE can cause side effects, although not everybody gets them.
Frequency not known: cannot be estimated from the available data

• hypersensitivity reactions, including hives, rash, redness, itching, allergic dermatitis, and other skin reactions.

Reporting side effects

If the patient experiences any side effects, including those not listed in the package leaflet, they should inform their 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 to gather more information on the safety of the medicine.

5. How to store Espumisan FORTE

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister or folding box after "EXP". The expiry date refers to the last day of the month.
The medicine should not be stored at a temperature above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Espumisan FORTE contains

The active substance is simeticone.
Each soft capsule of Espumisan FORTE contains 240 mg of simeticone.
The other ingredients are: gelatin, glycerol (E422)

What Espumisan FORTE looks like and contents of the pack

Espumisan FORTE is a transparent, round, soft, gelatin capsule with a diameter of 8.2 mm ± 1 mm, containing a slightly opalescent, grayish-white viscous liquid.
Espumisan FORTE is available in cardboard boxes containing 20 or 40 soft capsules packed in thermo-sealed blisters made of PVC/PVDC/Aluminum foil.
Not all pack sizes may be marketed.

Marketing authorization holder

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin, Germany

Manufacturer

LABORATORIOS ALCALÁ FARMA, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain
To obtain more detailed information about this medicine, the patient should 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

This medicine is authorized for sale in the Member States of the European Economic Area under the following names:

Bulgaria:
Еспумизан ФОРТЕ 240 mg меки капсули
Croatia: Espumisan forte 240 mg meke kapsule
Estonia:
Espumisan Forte
Finland:
Espumisan 240 mg pehmeät kapselit
Hungary:
Espumisan FORTE 240 mg lágy kapszula
Lithuania:
Espumisan 240 mg minkštosios kapsulės
Poland:
Espumisan FORTE
Romania:
Espumisan 240 mg capsule moi
Slovakia:
Espumisan FORTE 240 mg mäkké kapsuly
Slovenia:
Espumisan 240 mg mehke kapsule

Date of last revision of the package leaflet: 04/2025