Powder for oral solution 

Read all of this leaflet carefully before you start using this medicine.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, It may harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. WHAT ENDOFALK IS AND WHAT IT IS USED FOR 
2. BEFORE YOU USE ENDOFALK 
3. HOW TO USE ENDOFALK 
4. POSSIBLE SIDE EFFECTS 
5. HOW TO DISPOSE of ENDOFALK DISPOSAL 
6.

1. WHAT ENDOFALK IS AND WHAT IT IS USED FOR

Endofalk powder for oral solution contains a mixture of different salts and macrogol (an agent that softens the stool) and is used for bowel cleansing. More information on the substances can be found in section 6.

You should take Endofalk to clean your bowels before a colonoscopy. Endofalk works by emptying the contents of the intestines, so you should expect a watery stool.

2. BEFORE YOU USE ENDOFALK

Do not use Endofalk

  • if you are allergic to macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride
  • if you have a bowel movement or suspected bowel movement (paralytic ileus )
  • if you have a known or suspected bowel obstruction
  • if you have a hole ( perforation ) in the intestinal wall or a risk of getting a hole in the intestinal wall
  • if you have a serious inflammatory bowel disease, e.g. severe active ulcerative colitis, Crohn’s disease, or an enlarged colon (toxic megacolon)
  • if you have a stomach upset
  • if you have a general feeling of weakness and/or are faint
  • if you have a reduced level of consciousness
  • if you have difficulty swallowing
  • if you tend to put in your throat or draw food and/or fluids into your lungs.

Warnings and cautions

You should consult your doctor before using Endofalk if you:

  • if you have heart failure
  • if you have heart rhythm disorders ( cardiac arrhythmia )
  • if you have kidney failure
  • if you have liver disease
  • if you have a chronic inflammatory bowel disease
  • if you have inflammation of the esophagus (esophagus) due to reflux of stomach acids if you are severely dehydrated

If you are elderly or debilitated, your salt ( electrolyte ) and water levels must be carefully monitored.

If you experience sudden abdominal pain or rectal bleeding while taking Endofalk for bowel cleansing, contact a doctor immediately or seek medical attention.

Use of other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take any other medicines by mouth for several hours before or after taking Endofalk. They can be flushed out of the stomach and intestines or not taken up completely. Talk to your doctor if you need to take other important medicines; you can get an option.

Use of Endofalk with food and drink

Do not add other solutions or additives (especially not sugar or other flavorings) other than water to Endofalk powder. This can lead to a change in the strength of the solution or a change in the salt balance. Also, an explosive gas mixture can form in the intestines when the solution is broken down by intestinal bacteria.

Drink nothing but Endofalk solution and water.

Do not eat for 2-3 hours before taking Endofalk and until the study is completed.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is no experience with the use of Endofalk during pregnancy.

It is not known whether the active substance macrogol is excreted in human milk. This active substance is absorbed only to a very small extent in the gastrointestinal tract

If you are pregnant or breast-feeding, only use Endofalk if your doctor tells you to.

Driving and using machines

Endofalk does not affect your ability to drive or use machines.

Endofalk contains sodium and potassium

This medicine contains 747 mg of sodium per sachet. You should consider this if you are on a low-salt diet and contact a doctor or pharmacist.

This medicine contains 97.5 mg of potassium per sachet. You should consider this if you have impaired kidney function or if you are on a low-potassium diet.

3. HOW TO USE ENDOFALK

Always use Endofalk exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Remember that you must be near a toilet when taking Endofalk.

Prepare the solution:

Dissolve

  • p the contents of 2 sachets in ½ liters of water (lukewarm tap water or cooled, boiled water). Then pour in another ½ liter of water.
  • Do not add other solutions or additives (especially not sugar or other flavorings) other than water to the Endofalk solution.
  • Mix well until the solution is clear or slightly cloudy.
  • The finished solution can be placed in the refrigerator to cool. The solution tastes better if it is drunk cool.

The reconstituted solution can be stored for a maximum of three hours at room temperature (<25 ° C) or a maximum of 48 hours in a refrigerator (2–8 ° C).

Dosage for adults (over 18 years)

The usual dose is 3 liters to a maximum of 4 liters of Endofalk solution. You need 6 sachets dissolved in 3 liters of water to make 3 liters of solution and 8 sachets dissolved in 4 liters of water to make 4 liters of solution. (see Preparing the solution).

Drink 200-300 ml of the solution (approximately one large, full glass) every 10 minutes until the fluid from the rectum is clear.

Use for children

Endofalk should not be given to children.

When to take Endofalk solution:

You must have received written instructions from your doctor or nurse about when to take Endofalk.

Your treatment with Endofalk solution must be completed before the examination begins.

  • If you have time for examination in the afternoon, take the solution for a period of about 4 hours in the morning the same day. You can also take some of the solutions the night before and the rest the same morning as the examination.
  • If you have time for examination in the morning take the whole solution the evening before the examination for a period of about 4 hours.

Important

Do not eat for 2-3 hours before taking Endofalk and until the study is completed.

Drink nothing but Endofalk solution and water.

If you have the impression that the effect of Endofalk is too strong or too weak, talk to your doctor or pharmacist.

If you use more Endofalk than you should:

If you take more than 3-4 liters, equivalent to 6 to 8 sachets, you may have severe diarrhea. If this happens, consult your doctor and drink plenty of water. Stop taking Endofalk until diarrhea passes.

If you forget to use Endofalk:

If you drink much less Endofalk solution than recommended, your bowel may not be completely emptied and the test may not be performed as planned. Thus, carefully follow the dosing instructions given to you by your doctor or the recommendations in this leaflet.

If you forget to drink the solution, take the next dose when you remember. Continue according to the recommendations until you have drunk the required amount.

If you stop taking Endofalk

If you stop taking Endofalk solution too soon, the bowel may not be completely emptied and the examination may not be carried out 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 contact a doctor immediately if you experience any of the following side effects:

  • skin rash, itching, dizziness or difficulty breathing (signs of an allergic reaction ) or a severe allergic reaction (anaphylactic shock )
  • fatigue, feeling weak, thirst with headache, swelling of the ankles (signs of changes in body fluid or salt levels)
  • severe vomiting as this can lead to bleeding due to ulcers in the esophagus (Mallory-Weiss syndrome).

The following side effects are largely due to the ingestion of large amounts of liquid during a short period. If these occur, drink Endofalk more slowly for a period of time or stop drinking it until the symptoms disappear.

A very common side effect is (occurring in more than 1 in 10)

  • feeling sick
  • feeling of bloating
  • weather stresses.

Common adverse s (occurring in more than 1 in 100)

  • vomiting
  • abdominal pain
  • irritation around the rectal opening.

The following side effects may also occur:

The occurrence of these side effects is unknown as the available information can not be estimated:

  • hives, runny nose, or acute dermatitis
  • neurological symptoms which may include mild confusion to generalized seizures (as a result of disturbances of salts [electrolytes] in the blood)
  • signs of a severe allergic reaction (anaphylactic shock )
  • irregular or too fast heartbeats
  • accumulation of fluid in the lungs
  • general malaise and sleep problems
  • a decrease in salts ( calcium, potassium, sodium ) in the blood
  • vomiting followed by bleeding due to ulcers in the esophagus (Mallory-Weiss syndrome).

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.

5. HOW TO STORE ENDOFALK

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and carton. The expiration date is the last day of the specified month.

There are no special storage instructions for the powder.

The reconstituted solution can be stored for a maximum of three hours at room temperature (<25 ° C) or a maximum of 48 hours in a refrigerator (2–8 ° 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

Content declaration

Each sachet of Endofalk contains the following active substances:

Macrogol 3350 52,500 g
Sodium chloride 1,400 g
Sodium bicarbonate 0.715 g
Potassium chloride 0.185 g

The other ingredients are saccharin sodium, orange and passion fruit aromas, and anhydrous colloidal silica (see the end of section 2 for further information on sodium and potassium ).

What the medicine looks like the and contents of the pack

Endofalk is a white powder for oral solutions packaged in sachets.

Endofalk is available in packs of 6 or 72 sachets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Dr Falk Pharma GmbH

Leinenweberstrasse 5

79108 Freiburg

Germany

This medicinal product is authorized under the European Economic Area under the name:

Austria, Belgium, Bulgaria, Denmark, Germany, the United Kingdom, Greece, Finland, Ireland, Luxembourg, the Netherlands, Norway, Portugal, Romania, and Endofalk.

Muhammad Nadeem

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