ESPUMISAN

ESPUMISAN Gold Pearls against flatulence

Important notes (mandatory information)

Espumisan Gold Pearls against flatulence. Active ingredient: Simethicone. Field of application: for the symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness and functional dyspepsia and for the preparation of diagnostics in the abdominal area, such as endoscopy, X-ray and sonography.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Espumisan Gold Pearls against flatulence
Active ingredient: Simethicone

Please read all of this leaflet carefully because it contains important information for you. This product is available without a prescription. However, in order to achieve the best possible treatment results, Espumisan Gold Pearls against flatulence must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after a few days, you should see a doctor.

This package leaflet includes

1. WHAT ARE ESPUMISAN GOLD PEARLS AGAINST FLATULENCE AND WHAT ARE THEY USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING ESPUMISAN GOLD PEARLS AGAINST FLATULENCE?
3. HOW TO TAKE ESPUMISAN GOLD PEARLS AGAINST FLATULENCE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ESPUMISAN GOLD PEARLS AGAINST FLATULENCE AND HOW LONG ARE THEY SHELF-LIFE?
6. FURTHER INFORMATION

1. WHAT ARE ESPUMISAN GOLD PEARLS AGAINST FLATULENCE AND WHAT ARE THEY USED FOR?

This medical device is a so-called defoamer. It is used for the symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness and functional dyspepsia and for the preparation of diagnostics in the abdominal area, such as endoscopy, X-ray and sonography.

2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING ESPUMISAN GOLD PEARLS AGAINST FLATULENCE?

Espumisan Gold Pearls against flatulence must not be taken if you are hypersensitive (allergic) to simethicone or any of the other ingredients of Espumisan Gold Pearls against flatulence. Espumisan Gold Pearls against flatulence should only be used for fresh surgical wounds after gastrointestinal operations after careful clarification by your doctor.

Pregnancy and breastfeeding

There are no concerns about taking Espumisan Gold Pearls against flatulence during pregnancy and breastfeeding.

In children

Children under 14 years of age should not take this product for the symptomatic treatment of gas-related gastrointestinal complaints. Other dosage forms are available for this age group to achieve a suitable dosage (e.g. Espumisan Emulsion).

When taking Espumisan Gold Pearls against flatulence capsules with medicines

Interactions with medicines are not known.

3. HOW TO TAKE ESPUMISAN GOLD PEARLS AGAINST FLATULENCE?

Always take Espumisan Gold Pearls against flatulence exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure. Please follow the instructions for use, otherwise Espumisan Gold Pearls against flatulence will not work properly!

For gas-related gastrointestinal complaints

Age Single dose Total daily dose
Adults and adolescents from 14 years 1 - 2 soft capsules (corresponding to 140 - 280 mg simethicone) 3 - 6 soft capsules (corresponding to 420 - 840 mg simethicone)

For children under 14 years of age and infants, other dosage forms are available to achieve a suitable dosage (e.g. Espumisan Emulsion). Espumisan Gold Pearls against flatulence should be taken with or after meals, if necessary also before going to bed. The capsules are swallowed whole. You can also swallow Espumisan Gold Pearls against flatulence with some liquid (e.g. 1 glass of water) if this makes it easier for you to take them. The duration of use depends on the course of the symptoms. Espumisan Gold Pearls against flatulence can be taken for a longer period of time if necessary.

In preparation for imaging examinations

If your doctor has not given you any other dosage instructions, the following dosage is recommended

Age	the day before the examination	on the morning of the examination
Adults and adolescents from 6 years	2 – 3 soft capsules (corresponding to 280 – 420 mg simethicone)	1 soft capsule (corresponding to 140 mg simethicone)

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Side effects, if any, previously reported for Espumisan Gold Pearls against flatulence were of no clinical significance. If you notice any side effects, please inform the manufacturer or your doctor as stated in this leaflet.

5. HOW TO STORE ESPUMISAN GOLD PEARLS AGAINST FLATULENCE AND HOW LONG ARE THEY SHELF-LIFE?

Keep this product out of the reach of children. Do not use after the expiry date stated on the carton under "use by".

6. FURTHER INFORMATION

If you experience new and/or persistent abdominal pain, you should see a doctor so that the cause of the symptoms and any underlying condition that may require treatment can be identified. The active ingredient in Espumisan Gold Pearls against flatulence dissolves the foam in the gastrointestinal tract by purely physical means and is chemically and biologically completely ineffective. Therefore, poisoning is practically impossible. Even large amounts of Espumisan Gold Pearls against flatulence are well tolerated.

Composition

1 soft capsule contains 140 mg simethicone as the active ingredient. The other ingredients are gelatine, glycerol 85%, quinoline yellow (E 104) and iron oxide red (E172).

Espumisan Gold Pearls against flatulence are available in packs of 20 and 40 soft capsules.

Distributor

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin

Manufacturer

Catalent Germany Eberbach GmbH
Gammelsbacher Straße 2
69412 Eberbach

This package leaflet was last revised in May 2017.

Source: Information from the package leaflet
Status: 04/2018
Active ingredient: Simethicone. Field of application: for the symptomatic treatment of gas-related gastrointestinal complaints, e.g. flatulence (meteorism), feeling of fullness and functional dyspepsia and for the preparation of diagnostics in the abdominal area, such as endoscopy, X-ray and sonography.