ESPUMISAN 100MG/ML DROP EMULSIJA 30ML

ATC code: A03AX13 

Active substances: Simeticonum

Vendor, principal: Berlin-Chemie Ag. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ESPUMISAN 100MG/1ML 30ML

PACKAGE LEAFLET: INFORMATION FOR THE USER

Espumisan 100 mg/ml oral drops, emulsion

Simeticone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always use 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.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 deys.

What is in this leaflet:

1.   What Espumisan 100 mg/ml is and what it is used for
2.   What you need to know before you take Espumisan 100 mg/ml
3.   How to take Espumisan 100 mg/ml
4.   Possible side effects
5.   How to store Espumisan 100 mg/ml
6.   Contents of the pack and other information

1. What Espumisan 100 mg/ml is and what it is used for

This medicine treats the symptoms of flatulence (wind and trapped wind) and is suitable for all age-groups. It works by disintegrating gas bubbles embedded in the food mass and in the mucus of the digestive tract. The gases released in the process can then be taken up by the intestinal wall, as well as removed by intestinal movement.

Uses

Espumisan 100 mg/ml is used:
As self-medication:
-   for treating the symptoms of gas-related gastro-intestinal complaints, for example buildup of gas in the intestines (meteorism), flatulence.
Under the supervision of a doctor:
-   for treating the symptoms of gas-related gastro-intestinal complaints, for example when there is an increase in intestinal gas after operations;
-   for preparing diagnostic procedures in the abdominal region (e.g. X-ray and sonography, endoscopic examinations, as an adjunct to contrast media suspensions).
You must talk to a doctor if you do not feel better after 3 days or if you feel worse.

2. What you need to know before you use Espumisan 100 mg/ml Do not take Espumisan 100 mg/ml :

-   if you are allergic to simeticone or any of the other ingredients of this medicine (listed in section 6).
-   Please keep in mind when administering the medicine to others that this may also apply to them.

Warnings and precautions

Talk to your doctor or pharmacist before using Espumisan 100 mg/ml.
If you get new complaints, you must visit a doctor. Do not take this product for longer than 14 days without consulting a doctor.If your complaints have not cleared up in this time, see a doctor.

Children and adolescents

Particularly if used in infants and children, the doctor should be consulted.
Other medicines and Espumisan 100 mg/ml Interactions with other medicines are not known.
Espumisan 100 mg/ml with food and drink No special features are to be noted.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Since no clinical data on exposed pregnancies are available, the use of this medicine during pregnancy and breast-feeding is not recommended.

Driving and using machines

No special precautions are required.

Espumisan 100 mg/ml contains sorbitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Espumisan 100 mg/ml

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
There are two ways to measure a dose of Espumisan 100 mg/ml :
Depending on how high the dose is, dosing can take place with:
-   a dropper insert,
-   a measuring cap with millilitre (ml) graduation.
More detailed instructions on using the measuring devices can be found after the dose tables. Dose
Dose this medicine according to the intensity of the complaints.
The recommended dose is:
In self-medication of treating the symptoms of gas-related gastro-intestinal complaints

Age-group	Dosage in drops
	(dropper insert)

Infants	5 -10 drops each are put into the bottle feed or administered to the infant with a small spoon immediately before every breastfeeding
1 - 6 years	10 drops 3 to 5 times daily
6 - 14 years	10 - 20 drops 3 to 5 times daily
Adolescents   and adults	20 drops 3 to 5 times daily

It is also possible to take this medicine after operations under the supervision of a doctor.
This medicine is taken with or after meals, also before going to bed if necessary.
This medicine should be taken for as long as the complaints persist, yet no longer than 14 day without medical advice.
This medicine is suitable to be taken over a long period of time only upon medical advice. Please also read Section 2 “Warning and precautions”.
Before diagnostic procedures as directed by the doctor

Dosage in ml

(measuring cap)_
1 ml 3 times daily after meals on the day before the examination and 1 ml on the morning of the examination
In addition to contrast media suspensions under the supervision of a doctor

Dosage in ml

(measuring cap)_
2 - 4 ml to 1 litre of contrast meal for double-contrast imaging
Before examination of the stomach and small intestine (endoscopy) under the supervision of a
doctor

Dosage in ml

(measuring cap)_
2 - 3 ml before endoscopy
If necessary, a few more ml of the emulsion can be put through the instrument canal of the endoscope during the examination to eliminate interfering foam bubbles.
Method of use Shake well before use!

Using the dropper insert (10 - 25 drops):

The bottle must be held vertically with the dropper insert facing downwards.
25 drops are equivalent to 1 ml of the emulsion (equivalent to 100 mg simeticone).

Using the measuring cap:

As a measuring device, a measuring cap with ml graduation is attached to the screw-cap of the 30-ml and 50-ml dropper bottles. If necessary (for example with doses of 25 drops and more), it can be pulled off and used instead of the dropper insert to measure off the dose. Note: Due to the danger of swallowing, the measuring cap should be kept away from children.

If you take more Espumisan 100 mg/ml than you should

Taking too much this medicine is unlikely to cause any ill effect. Even large quantities of this medicine are tolerated without causing problems. The active substance of this medicine, simeticone, makes foam in the gastro-intestinal canal disintegrate in a purely physical way. Simeticone is not absorbed and not changed chemically or enzymatically during passage through the intestines.

If you forget to take Espumisan 100 mg/ml

You can make up for the dose at any time.
If you stop taking Espumisan 100 mg/ml There may be a recurrence of the complaints.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

To date, this medicine has not been associated with any side effects.
If you notice any side effects, please tell your doctor or pharmacist.

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.
If you notice any side effects, please fell your doctor or pharmacist.

5. How to store Espumisan 100 mg/ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and label after "EXP". The expiry date refers to the last day of that month.
No special storage conditions are required for this medicine.
This medicine can be used for up to 6 months after first opening.
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 to protect the environment.

6. Contents of the pack and other information What Espumisan 100 mg/ml contains

-   The active substance is simeticone.
1 ml of oral emulsion contains 100 mg simeticone.
-   The other ingredients are:
Macrogol stearate, glycerol monostearate 40-55, sorbic acid, sodium hydroxide for pH adjustment, acesulfame potassium, sodium chloride, liquid sorbitol (non-crystallising) (E 420), carbomer, sodium citrate, banana flavour, purified water

What Espumisan 100 mg/ml looks like and contents of the pack

Espumisan 100 mg/ml is a milky-white, slightly viscous emulsion in a labelled 30-ml or 50-ml amber-glass bottle with dropper insert, temper-evident cap (screw cap with breakable ring) and attached measuring cap.
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. 29 10612 Tallinn Estonia
Phone: +372 667 5001

This leaflet was last revised in February 2018.