ESPUMISAN 100 MG/1ML ORAL DROPS EMULSION
Active substance(s): SIMETICONE
- PDF options:
- View fullscreen
- Download PDF
PDF Transcript
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.
2.
3.
4.
5.
6.
1.
What Espumisan 100 mg/ml oral drops, emulsion is and what it is used for
Before you use Espumisan 100 mg/ml oral drops, emulsion
How to use Espumisan 100 mg/ml oral drops, emulsion
Possible side effects
How to store Espumisan 100 mg/ml oral drops, emulsion
Further information
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).
Espumisan 100 mg/ml oral drops, emulsion
Page 1 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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.
Espumisan 100 mg/ml oral drops, emulsion
Page 2 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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 20 drops 3 to 5 times daily
adults
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
Dosage in ml
(measuring cap)
2 - 4 ml to 1 litre of contrast meal for
Espumisan 100 mg/ml oral drops, emulsion
Page 3 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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.
Espumisan 100 mg/ml oral drops, emulsion
Page 4 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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.
Espumisan 100 mg/ml oral drops, emulsion
Page 5 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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) Espumisan 100 mg/ml oral drops, emulsion
Bulgaria
Еспумизан комфорт 100 mg/ml перорални капки,
емулсия
Czech Republic
Espumisan kapky 100 mg/ml
Estonia
Espumisan 100 mg/ml
Finland
Espumisan 100mg/ml tipat, emulsio
Hungary
Espumisan 100 mg/ml belsőleges emulzió
Latvia
Espumisan 100 mg/ml emulsija iekšķīgai lietošanai
Poland
Espumisan 100 mg/ml
Romania
Espumisan 100 mg/ml, picături orale, emulsie
Slovenia
Espumisan 100 mg/ml, peroralne kapljice, emulzija
Slovak Republic
Espumisan comfort 100 mg/ml perorálne emulzné
kvapky
This leaflet was last revised in 12/2013.
Espumisan 100 mg/ml oral drops, emulsion
Page 6 of 6
2013-12-02
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.
2.
3.
4.
5.
6.
1.
What Espumisan 100 mg/ml oral drops, emulsion is and what it is used for
Before you use Espumisan 100 mg/ml oral drops, emulsion
How to use Espumisan 100 mg/ml oral drops, emulsion
Possible side effects
How to store Espumisan 100 mg/ml oral drops, emulsion
Further information
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).
Espumisan 100 mg/ml oral drops, emulsion
Page 1 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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.
Espumisan 100 mg/ml oral drops, emulsion
Page 2 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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 20 drops 3 to 5 times daily
adults
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
Dosage in ml
(measuring cap)
2 - 4 ml to 1 litre of contrast meal for
Espumisan 100 mg/ml oral drops, emulsion
Page 3 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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.
Espumisan 100 mg/ml oral drops, emulsion
Page 4 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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.
Espumisan 100 mg/ml oral drops, emulsion
Page 5 of 6
2013-12-02
DCP no. UK/H/1398/01/DC
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) Espumisan 100 mg/ml oral drops, emulsion
Bulgaria
Еспумизан комфорт 100 mg/ml перорални капки,
емулсия
Czech Republic
Espumisan kapky 100 mg/ml
Estonia
Espumisan 100 mg/ml
Finland
Espumisan 100mg/ml tipat, emulsio
Hungary
Espumisan 100 mg/ml belsőleges emulzió
Latvia
Espumisan 100 mg/ml emulsija iekšķīgai lietošanai
Poland
Espumisan 100 mg/ml
Romania
Espumisan 100 mg/ml, picături orale, emulsie
Slovenia
Espumisan 100 mg/ml, peroralne kapljice, emulzija
Slovak Republic
Espumisan comfort 100 mg/ml perorálne emulzné
kvapky
This leaflet was last revised in 12/2013.
Espumisan 100 mg/ml oral drops, emulsion
Page 6 of 6
2013-12-02
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
