ESPUMISAN EASY 125MG N14

Code: A03AX13 

Active substances: Silicones

Vendor, principal: Fairpharm Vertriebs Gmbh. 

ESPUMISAN 40MG N50

Package leaflet: Information for the user Espumisan 40 mg soft capsules

Active substance: simeticone

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.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   Y ou must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1.   What Espumisan is and what it is used for
2.   What you need to know before you take 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 is used for symptomatic treatment of flatulence and as a supplementary agent for preparation of gastrointestinal tract diagnostic investigations in children from 6 years of age, adolescents and adults.
You must talk to a doctor if you do not feel better or if you feel worse.

2.   What you need to know before you take Espumisan Do not take Espumisan

-   if you are allergic to simeticone, sunset yellow (E110), methyl parahydroxybenzoate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor if the abdominal complaints recur or persist for a longer time. These complaints may be caused by a possible concurrent disease that should be prescribed adequate treatment.

Other medicines and Espumisan

Interactions of Espumisan with other medicines have not been observed so far.

Pregnancy, breast-feeding and fertility

Espumisan may be used during pregnancy and breast-feeding.

Driving and using machines

No special requirements.

Espumisan contains methyl parahydroxybenzoate and sunset yellow (E 110):

Due to methyl parahydroxybenzoate content urticaria (hives) may occur during the use of this medicine. Also delayed-type reactions like contact dermatitis are possible. Early-type reactions with urticaria and bronchospasm (spasm of bronchial muscles) occur rarely.
The medicine contains colouring agent sunset yellow (E110), which may cause allergy-like reactions, including asthma in people who are especially sensitive to this substance. Allergy occurs more often in people who are allergic to acetylsalicylic acid.

3. How to take Espumisan

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For gastrointestinal complaints caused by flatulence:
The recommended dose for children over 6 years of age, adolescents and adults is 2 Espumisan capsules 3-4 times a day.
For preparation for diagnostic investigations:
2 Espumisan capsules 3 times (corresponds to 240 mg of simeticone) on a day before the investigation and 2 Espumisan capsules (corresponds to 80 mg of simeticone) in the morning of investigation day.
Espumisan is sugar-free and suitable for use in diabetics and patients with nutrition disorders.
Espumisan is taken during or after meal, also before going to sleep, if required.
The duration of treatment is determined by the course of the complaints. Espumisan may be used for longer time, if required.
If you feel that the effect of Espumisan is too strong or too weak, talk to your doctor or pharmacist.

If you take more Espumisan than you should

Cases of intoxication are not known. The active substance of Espumisan breaks up the gas bubbles in the gastrointestinal tract physically and is chemically and biologically inactive. Therefore the possible intoxication is practically excluded. Also high doses of Espumisan are well tolerated.

If you forget to take Espumisan

The new dose may be taken at any suitable time.

If you stop taking Espumisan

The symptoms may recur.
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 everybody gets them.
Allergic reactions may occur with Espumisan use. See Espumisan contains methyl parahydroxybenzoate and sunset yellow (E110)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Espumisan

Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
Do not use Espumisan after the expiry date which is stated on the blister or carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Espumisan contains

-   The active substance is simeticone. Each soft capsule contains 40 mg of simeticone.
-   The other excipients are methyl parahydroxybenzoate (E 218), gelatin, glycerol (85%), quinoline yellow (E104), sunset yellow FCF (E110).

What ESPUMISAN looks like and contents of the pack

Almost round yellow smooth-surfaced gelatin soft capsules. Capsule contents are colourless, slightly turbid.
Espumisan is packaged in PVC/aluminium blister by 25, 50 or 100 in a package.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer BERLIN-CHEMIE AG (MENARINI GROUP)
Glienicker Weg 125 12489 Berlin,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
OÜ Berlin-Chemie Menarini Eesti Paldiski mnt. 27/29 Tallinn 10612 Estonia

This leaflet was last revised in July 2014.

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