Espumisan 100 Mg/1ml Oral Drops Emulsion
DCP no. UK/H/1398/01/DC
PACKAGE LEAFLET: INFORMATION FOR THE USER Espumisan 100 mg/ml oral drops, emulsion
100 mg/ml, oral drops, emulsion Active substance: simeticone
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Espumisan comfort carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if the symptoms worsen or do not improve.
- If you notice a side effect, please tell your doctor or pharmacist._
In this leaflet:
1. What Espumisan 100 mg/ml oral drops, emulsion is and what it is used for
2. Before you use Espumisan 100 mg/ml oral drops, emulsion
3. How to use Espumisan 100 mg/ml oral drops, emulsion
4. Possible side effects
5. How to store Espumisan 100 mg/ml oral drops, emulsion
6. Further information
1. What Espumisan 100 mg/ml oral drops, emulsion is and what it is used for
Espumisan 100 mg/ml oral drops, emulsion 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 oral drops, emulsion is used:
- for treating the symptoms of gas-related gastro-intestinal complaints, for example build up of gas in the intestines (meteorism), flatulence or 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).
2. Before you use Espumisan 100 mg/ml oral drops, emulsion
Do not use Espumisan 100 mg/ml oral drops, emulsion:
- if you are allergic (hypersensitiv) to the active substance simeticone or any of the other ingredients of Espumisan 100 mg/ml oral drops, emulsion. Please keep in mind when administering Espumisan 100 mg/ml oral drops, emulsion to others that this may also apply to them.
Take special care with Espumisan 100 mg/ml oral drops, emulsion
In both new and/or persistent stomach complaints you should visit a doctor. They will investigate whether there is an underlying disease that requires other treatment.
Particularly if used in infants and children, the doctor should be consulted.
Taking other medicines
Interactions with other medicines are not known.
Taking Espumisan 100 mg/ml oral drops, emulsion with food and drink
No special features are to be noted.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Since no clinical data on exposed pregnancies are available, the use of Espumisan 100 mg/ml oral drops, emulsion during pregnancy and breast-feeding is not recommended.
Driving and using machines
No special precautions are required.
Important information about some of the ingredients of Espumisan 100 mg/ml oral drops, emulsion
This medicinal product contains sorbitol. If you have been told by your doctor that an intolerance to some sugars exists, contact your doctor before using this medicinal product.
3. How to use Espumisan 100 mg/ml oral drops, emulsion
Always use Espumisan 100 mg/ml oral drops, emulsion exactly according to the instructions in this package leaflet. You should check with your doctor or pharmacist if you are not sure.
There are two ways to measure a dose of Espumisan 100 mg/ml oral drops, emulsion:
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.
Dosage
Dose Espumisan 100 mg/ml oral drops, emulsion according to the intensity of the complaints.
The usual dose is:
For 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 breast-feeding |
|
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 Espumisan 100 mg/ml oral drops, emulsion after operations.
Espumisan 100 mg/ml oral drops, emulsion is taken with or after meals, also before going to bed if necessary.
Espumisan 100 mg/ml oral drops, emulsion should be taken for as long as the complaints persist.
Espumisan 100 mg/ml oral drops, emulsion is suitable to be taken over a long period of time only upon medical advice. Please also read Section 2 "Take special care”.
For preparing diagnostic procedures
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
As an adjunct to contrast media suspensions
double-contrast imaging
For preparing inspections of the stomach and small intestine (endoscopy)
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 use more Espumisan 100 mg/ml oral drops, emulsion than you should
Taking too much Espumisan 100 mg/ml oral drops, emulsion is unlikely to cause any ill effect. Even large quantities of Espumisan 100 mg/ml oral drops, emulsion are tolerated without causing problems. The active substance of Espumisan 100 mg/ml oral drops, emulsion, 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 use Espumisan 100 mg/ml oral drops, emulsion
You can make up for the dose at any time.
If you stop using Espumisan 100 mg/ml oral drops, emulsion
There may be a recurrence of the complaints.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
To date, Espumisan 100 mg/ml oral drops, emulsion has not been associated with any side effects.
If you notice any side effects, please tell your doctor or pharmacist.
5. How to store Espumisan 100 mg/ml oral drops, emulsion
No special storage conditions are required for this medicine.
Keep out of the reach and sight of children.
Do not use Espumisan 100 mg/ml oral drops, emulsion 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.
Espumisan 100 mg/ml oral drops, emulsion can be used for up to 6 months after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Espumisan 100 mg/ml oral drops, emulsion 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 (noncrystallising) (E 420), carbomer, sodium citrate, banana flavour, purified water
What Espumisan 100 mg/ml oral drops, emulsion looks like and contents of the pack
Espumisan 100 mg/ml oral drops, emulsion is a milky-white, slightly viscous emulsion in a labelled 30-ml or 50-ml amber-glass bottle with dropper insert, screw-cap 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
This medicinal product is authorised in the Member States of the EEA under the following names:
|
United Kingdom (RMS) Bulgaria Czech Republic Estonia Finland Hungary Latvia Poland Romania Slovenia Slovak Republic |
Espumisan 100 mg/ml oral drops, emulsion EcnyMU3aH kom^opt 100 mg/ml nepopanHM KanKU, eMyncua Espumisan kapky 100 mg/ml Espumisan 100 mg/ml Espumisan 100mg/ml tipat, emulsio Espumisan 100 mg/ml belsoleges emulzio Espumisan 100 mg/ml emulsija ieksklgai lietosanai Espumisan 100 mg/ml Espumisan 100 mg/ml, picaturi orale, emulsie Espumisan 100 mg/ml, peroralne kapljice, emulzija Espumisan comfort 100 mg/ml peroralne emulzne kvapky |
This leaflet was last revised in 12/2013.
Espumisan 100 mg/ml oral drops, emulsion Page 6 of 6 2013-12-02