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

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.

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.

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.

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.

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:

DR. FALK PHARMA GmbH

Tel.: +49 (0)761/1514-0 Fax: +49(0)761/1514-321 E-Mail: zentrale@drfalkpharma.de

This leaflet was last approved in 05/2011

Marketing authorization number: PL08637/0004

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

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.

-    Macrogol 3350    52.500g

-    Sodium chloride    1.400g

-    Sodium hydrogen carbonate 0.715g

-    Potassium chloride    0.185g