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ENDOFALK POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Endofalk ® Powder
for oral solution
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 Endofalk® carefully to get the best results from it.
– Keep this leaflet. You may need to read it again.
– Ask your doctor or pharmacist if you need more information
or advice.
– If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Endofalk® is and what it is used for
2. Before you take Endofalk®
3. How to take Endofalk®
4. Possible side effects
5. How to store Endofalk®
6. Further information
1. WHAT ENDOFALK® IS AND WHAT IT IS USED FOR
Endofalk® Powder for oral solution contains a mixture of various salts
and macrogol (a stool softener) and is used as a bowel cleansing
agent. For further details on the ingredients please see Section 6.
You are taking Endofalk® to make your bowels clean so that they are
ready for examination (colonoscopy).
Endofalk® works by emptying the contents of your bowels, so you
should expect to have watery bowel movements.
2. BEFORE YOU TAKE ENDOFALK®
Do NOT take Endofalk® if you have:
– an allergy (hypersensitivity) to any of the ingredients contained
in this medicine (see Section 6 and end of Section 2).
– paralysis or suspected paralysis of your gut (ileus)
– a blockage or suspected blockage in your intestine
– a perforated gut wall or danger of a perforated gut wall
– severe inflammatory bowel disease such as severely
active ulcerative colitis, Crohn´s disease or an enlarged
colon (toxic megacolon)
– a disorder of stomach emptying
– general weakness and / or are feeling faint
– a reduced level of consciousness
– a problem swallowing
– a tendency to choke or breathe in food and / or fluids.

Take special care with Endofalk®
Talk to your doctor before taking Endofalk® if you have:
– heart failure
– heart rhythm disturbance (cardiac arrhythmia)
– kidney failure
– liver disease
– chronic inflammatory bowel disease
– inflammation of the oesophagus because of reflux of gastric acid
– severe dehydration
If you are elderly or debilitated, your salt (electrolyte) and water
levels will be carefully monitored.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, including medicines obtained
without a prescription.
Do not take any other medicines by mouth several hours before
or after taking Endofalk®. They may be flushed out of your stomach
and bowels or may not be completely absorbed. Speak to your
doctor if you need to take any vital medications; an alternative
may be given.
Taking Endofalk® with food and drink
Do not add any other solutions or additives (especially sugar or
flavouring substances) to Endofalk® Powder except for water. This
could lead to a change in the strength of the solution or in the salt
balance. In addition, when the solution is broken down by the
intestinal bacteria, explosive mixtures of gases can develop in the
intestine.
Do not drink anything other than the Endofalk® solution and water.
Do not eat any food from 2 – 3 hours before taking Endofalk® until
after your examination.
Pregnancy and breastfeeding
There is no experience with the use of Endofalk® during pregnancy.
It is not known if the active substance macrogol is excreted in
milk. This active substance is taken up from your gastrointestinal
tract only to a very minor extent.
If you are pregnant or breastfeeding you can use Endofalk® only
if your doctor tells you to.
Driving and using machines
Endofalk® does not affect your ability to drive and use machines.
Important information about some of the ingredients
of Endofalk®
Endofalk® contains:
– Sodium - 747 mg of sodium per sachet. This should be taken
into consideration if you are on a sodium-controlled diet. If
this is the case please contact your doctor or pharmacist.

3. HOW TO TAKE ENDOFALK®
Always use Endofalk® exactly as your doctor has told you. Please
check with your doctor or pharmacist if you are not sure.
Remember you need to be close to toilet facilities whilst you are
taking Endofalk®.
Preparation of the solution:
– Empty the contents of 2 sachets of Endofalk® in half a litre of
water (lukewarm tap water or cooled boiled water). Then add
another half-litre of water.
– Do not add any other solutions or additives (especially not sugar
or flavouring substances) to the Endofalk® solution except for
water.
– Stir well until all the solution is clear or slightly hazy.
– The prepared solution can then be put into a refrigerator to cool.
The solution may be more pleasant to drink when it is cool.
The ready-to-drink solution can be stored for not more than 3
hours at room temperature (below 25 °C) or for a maximum of 48
hours in the refrigerator (2 °C – 8 °C).
Dosage for adults (over 18 years of age)
The usual dose is 3 litres to a maximum of 4 litres of Endofalk®
solution. To make up 3 litres of solution you will need 6 sachets
dissolved in 3 litres of water, and to prepare 4 litres of solution you
will need 8 sachets dissolved in 4 litres of water (see Preparation
of the solution).
Drink 200ml – 300ml of the solution (about one large glass full)
every 10 minutes until bowel movements are clear liquid only.
Children
Endofalk® should not be given to children.
When to take Endofalk® solution:
You should have been given instructions about when to take
Endofalk® by your doctor or nurse.
Your treatment with Endofalk® solution must be completed before
your examination.
– If you have an afternoon appointment for the examination,
take the solution over a period of about 4 hours in the morning
of this day. Alternatively, take part of it on the evening before
and the remainder on the morning of the examination day.
– If you have a morning appointment for the examination, take
the entire solution on the evening before the examination day
over a period of about 4 hours.
Important:
Do not eat any food from 2 – 3 hours before administration of
Endofalk® until after the examination.
Do not drink anything other than the Endofalk® solution and water.

If you feel that the effect of Endofalk® is too strong or too weak,
talk to your doctor.
If you take more Endofalk® than you should:
If you take more than 3 to 4 litres, corresponding to 6 to 8 sachets,
you may develop severe diarrhoea. If this happens, contact your
doctor and drink plenty of fluid. Stop taking Endofalk® until it clears.
If you forget to take Endofalk®:
If you drink a lot less than the recommended amount of Endofalk®
solution, your bowel may not be completely emptied. Therefore it
may not be possible to carry out the examination as planned. To
avoid this please follow the dosage recommendations given by
your doctor and the instructions in this leaflet carefully.
If you forget to drink the solution, take the next dose as soon as
you remember to take it. Continue as recommended until you
have drunk all the required quantity.
If you stop taking Endofalk®:
If you stop taking Endofalk® solution too soon, your bowel may not
be completely emptied. Therefore it may not be possible to carry
out the examination as planned.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Endofalk® can cause side effects, although not
everybody gets them.
Stop taking Endofalk® and see your doctor immediately if you
experience any of the following side effects:
– Skin rash, itching, dizziness or difficulty in breathing (signs of an
allergic reaction) or serious allergic reaction (anaphylactic shock)
– Tiredness, feeling weak, very thirsty with headache, swelling of
the ankles (signs of changes in your body´s fluid or electrolyte
levels)
– Severe vomiting as this could lead to bleeding due to tearing of
the gullet (Mallory-Weiss syndrome)
The following side effects are largely due to drinking relatively
large amounts of fluid within a short time. If they occur, slow
down drinking Endofalk® solution temporarily or stop drinking until
symptoms disappear.
Very common side effects (more than 1 in 10 patients):
– Feeling sick
– A feeling of fullness
– Suffering from wind

Common side effects (less than 1 in 10 patients):
– Vomiting
– Stomach cramps
– Irritation of the anus
The following side effects are also possible:
The frequency of these side effects is unknown as it cannot be
estimated from the available data:
– Nettle rash, nasal discharge, runny nose or acute inflammation
of the skin
– Neurological symptoms that can range from mild disorientation
to generalised seizures (resulting from a disturbance of salts
(electrolytes) in the blood)
– Signs of a severe allergic reaction (anaphylactic shock)
– Irregular or too rapid heartbeat
– Accumulation of fluid in the lungs
– Generally feeling unwell and sleeping problems
– A decrease in the blood levels of salts (calcium, potassium,
sodium)
– Vomiting followed by bleeding due to tearing of the gullet
(Mallory-Weiss syndrome)
If any of the side effects get serious or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE ENDOFALK®
Keep out of the reach and sight of children.
Do not use Endofalk® after the expiry date which is stated on the
sachet and on the carton. The expiry date refers to the last day of
that month.
There are no special precautions for the storage of the powder.
The ready-to-drink solution can be stored for no more than 3 hours
at room temperature (below 25 °C) or for a maximum of 48 hours
in the refrigerator (2 °C – 8 °C).
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 Endofalk® contains:
Each sachet of Endofalk® contains the following active substances:
– Macrogol 3350
52.500g
– Sodium chloride
1.400g
– Sodium hydrogen carbonate
0.715g
– Potassium chloride
0.185g

The other ingredients are saccharin sodium, orange and passion
fruit flavour, and colloidal anhydrous silica (see end of Section 2 for
further information about sodium).
What Endofalk® looks like and contents of the pack:
Endofalk® is a white powder for oral solution packed in sachets.
Endofalk® is available in packs of 6 or 72 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:

This leaflet was last approved in 05/2011
Marketing authorization number: PL08637/0004

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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