ESPUMISAN FORTE 240mg x 20 caps
Leaflet: information for the user
Espumizan FORTE 240 mg soft capsules
simethicone
Espumisan FORTE 240 mg soft capsules
simethicone
Read all of this leaflet carefully before you start taking this medicine,
because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better after three days or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Espumisan FORTE is and what it is used for
2. What you need to know before you take Espumisan FORTE
3. How to take Espumisan FORTE
4. Possible side effects
5. How to store Espumisan FORTE
6. Contents of the pack and other information
1. What Espumisan FORTE is and what it is used for
Espumisan FORTE contains the active substance simethicone, which is a gastrointestinal aid as well as a diagnostic tool.
The active ingredient, simethicone, causes gas bubbles embedded in food and mucus in the gastrointestinal tract to break down. The gases released in the process can then be absorbed by the intestinal wall and eliminated through bowel movements.
Therapeutic indications
- For the symptomatic treatment of complaints related to gas in the stomach or intestines, for example flatulence (flatulence) or bloating and a feeling of fullness.
- In preparation for imaging studies in the abdominal area, such as X-rays and ultrasounds, after consulting a doctor.
Espumisan FORTE is used to treat adults and adolescents over 15 years of age.
Gas-related complaints can also be a sign of functional disorders in the gastrointestinal tract and manifest as a feeling of pressure and fullness, premature feeling of having eaten enough, belching, intestinal rumbling, and bloating.
You should seek medical attention if you do not feel better after three days or if you feel worse.
2. What you need to know before you take Espumisan FORTE
Do not take Espumisan FORTE
- if you are allergic to simethicone or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Espumisan FORTE.
If the complaints recur and/or persist for more than 3 days, you should seek medical attention to determine the cause of the complaints and possibly an underlying condition that requires treatment.
Other medicines and Espumisan FORTE
You should tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
No interactions with other drugs are known. Due to the surfactant properties of simethicone, pharmacokinetic interactions cannot be excluded.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There are no data on the use of simethicone in the treatment of pregnant women. Animal studies are insufficient to assess reproductive toxicological effects. No effects are expected during pregnancy, since systemic exposure to simethicone is negligible.
Breastfeeding
No effects on the breastfed infant are expected, as the systemic exposure of the nursing mother to simethicone is negligible.
Driving and using machines
Espumisan FORTE has no or negligible influence on the ability to drive and use machines.
3. How to take Espumisan FORTE
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Dosage
The recommended dose for adolescents over 15 years of age and adults is:
For the treatment of gastrointestinal complaints related to gas, for example gas accumulation (flatulence or bloating and feeling of fullness:
Take one capsule of Espumisan FORTE after each of the main meals (lunch and dinner). Do not exceed the maximum daily dose of 3 capsules.
By doctor's prescription for preparation for diagnostic examinations in the abdominal area, such as X-rays and echography (ultrasound)
One capsule of Espumisan FORTE the day before the examination.
Patients with hepatic or renal impairment
No dose adjustment is necessary.
Elderly patients
There is no specific information comparing the use of simethicone in elderly patients with use in other age groups.
Use in children
Espumisan FORTE is not recommended for infants and children under 15 years of age.
Method of administration
Espumisan FORTE should be taken after main meals, with a glass of water.
Take Espumisan FORTE as long as you have symptoms. If necessary, Espumisan FORTE can be taken for up to 30 days. Please also see point 2:
"Warnings and precautions".
Please talk to your doctor or pharmacist if you think the effect of Espumisan FORTE is too strong or too weak.
If you take more Espumisan FORTE than you should
Poisoning after an overdose of Espumisan FORTE is practically impossible. Even large amounts of Espumisan FORTE are tolerated without any problems.
The active substance of Espumisan FORTE, simethicone, causes the breakdown of gas bubbles in the gastrointestinal tract in a completely physical way.
Simethicone does not enter the bloodstream and is not chemically or biologically changed during passage through the intestines.
If you forget to take Espumisan FORTE
You can make up the dose at any time.
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Not known: frequency cannot be estimated from the available data
Allergic reactions, including urticaria, rash, skin redness, itching, allergic dermatitis and other skin reactions.
Reporting side effects
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, Bulgaria Tel.: +359 2 8903417, website: www.bda.bg. By reporting side effects, you can help to provide more information on the safety of this medicine.
5. How to store Espumisan FORTE
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Espumisan FORTE contains
The active substance is simethicone.
Each Espumisan FORTE soft capsule contains 240 mg of simethicone.
The other ingredients are:
Gelatin, glycerol (E422).
What Espumisan FORTE looks like and what the pack contains
Espumisan FORTE is a transparent round soft gelatin capsule with a diameter of 8.2 mm ± 1 mm, containing a viscous liquid, slightly opalescent and gray-white.
Espumisan FORTE is available in cartons containing 20 or 40 soft capsules, packed in heat-sealed PVC/PVDC/aluminium blisters.
Not all types of packaging can be released for sale.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
Manufacturer
LABORATORIOS ALCALÁ FARMA, SL
Madrid Avenue, 82
28802 Alcalá de Henares (Madrid)
Spain
or
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
This medicine is authorised in the Member States of the European Economic Area under the following names:
Bulgaria: Espumisan FORTE 240 mg soft capsules
Croatia: Espumisan forte 240 mg soft capsules
Estonia: Espumisan Forte
Finland: Espumisan 240 mg rehmeät kapselit
Hungary: Espumisan FORTE 240 mg lágy kapszula
Lithuania: Espumisan 240 mg soft capsules
Poland: Espumisan FORTE
Romania: Espumisan 240 mg capsule moi
Slovakia: Espumisan FORTE 240 mg mökké kapsuly
Slovenia: Espumisan 240 mg mehke kapsule
Date of last revision of the leaflet:
07/2025