Package leaflet: Information for the

user
Espumisan FORTE
240 mg, soft capsules
Simeticonum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or
as directed by the physician or pharmacist.

Keep this leaflet for future reference.
If advice or additional information is needed, consult a pharmacist.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 3 days or the patient feels worse, contact a doctor.

Table of contents

What Espumisan FORTE is and what it is used for
Important information before taking Espumisan FORTE
How to take Espumisan FORTE
Possible side effects
How to store Espumisan FORTE
Contents of the pack and other information

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

Espumisan FORTE contains the active substance simeticone, which is used
in gastrointestinal disorders and as an adjunct in diagnostic procedures.
The active substance in this medicine – simeticone – breaks down 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.
Indications
For symptomatic self-treatment of:

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

On medical advice:

as an adjunct in patient preparation for abdominal diagnostic examinations, such as radiological and ultrasonographic (US) imaging.

Espumisan FORTE is indicated for use in adolescents aged 15 years and older and adults.
Gas-related symptoms may also indicate functional disorders of the gastrointestinal tract,
manifesting as a sensation of pressure and fullness in the abdominal cavity, early satiety,
belching, intestinal rumbling, and bloating.
If no improvement occurs within 3 days or the patient feels worse, consult a doctor.

2. Information before using Espumisan FORTE

When not to use Espumisan FORTE

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

Warnings and precautions
Before starting to use Espumisan FORTE, consult your doctor or
pharmacist.
If new and/or persistent abdominal symptoms occur for 3 days, consult a doctor to determine the cause of symptoms and diagnose any possible disease requiring treatment.

Espumisan FORTE and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take or use.
No interactions with other medicines are known. Due to the surface-active properties of simethicone, pharmacokinetic interactions cannot be excluded.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
There is a lack of data on the use of simethicone in the treatment of pregnant women. Animal studies are insufficient to assess toxic effects on reproduction. No effect on pregnancy is expected, as systemic exposure to simethicone is negligible.

Breastfeeding
No effect on newborns/breastfed infants is expected, as systemic exposure of the breastfeeding mother to simethicone is negligible.

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

3. How to use Espumisan FORTE

This medicine should always be taken exactly as described in this patient information leaflet or
as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
Recommended dose for adolescents aged 15 years and adults:
For self-treatment of gastrointestinal discomfort associated with excessive gas accumulation,
e.g. bloating, feeling of fullness in the abdominal cavity:
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.
Upon doctor's instruction, as an aid in preparation for diagnostic examinations of the abdominal
area, e.g. radiological or ultrasonographic (ultrasound) examinations:
One capsule of Espumisan FORTE per day before the examination.
Patients with impaired liver or kidney function
Dosage adjustment is not necessary.
Elderly patients
There are no specific comparative data on the use of simethicone in elderly patients versus
other age groups.
Use in children
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 for as long as symptoms persist. If necessary, Espumisan
FORTE may be taken for up to 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
discuss this with their doctor or pharmacist.
Taking more Espumisan FORTE than recommended
Poisoning due to overdose of Espumisan FORTE is practically impossible. Even large doses
are well tolerated.
The active substance of the medicine – simethicone – eliminates foam in the gastrointestinal
tract through purely physical action. Simethicone is not absorbed by the body and undergoes
no chemical or biological transformation as it passes through the intestines.
Missed dose of Espumisan FORTE
A missed dose can be taken at any time.
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicinal products, this medicine can cause adverse effects, although not everyone experiences them.
Frequency unknown: cannot be estimated based on available data

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Espumisan FORTE

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or folding carton after "EXP". The expiry date refers to the last day of the specified 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 required. Such measures help protect the environment.

6. Contents of the pack and other information

What Espumisan FORTE contains
The active substance is simethicone.
Each soft capsule of Espumisan FORTE contains 240 mg of simethicone.
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, 8.2 mm in diameter ± 1 mm, containing a slightly opalescent, greyish-white, viscous liquid.
Espumisan FORTE is available in cardboard boxes containing 20 or 40 soft capsules packed in thermoformed blisters made of PVC/PVDC/Aluminium foil.
Not all pack sizes may be marketed.

Marketing Authorisation 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
or
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

For further information about 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

This medicinal product is authorised in 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