ENDOFALK 6 sachets

What information is in this leaflet:
1. What Endofalk and what is it used?
2. What you need to know before taking Endofalk?
3. How to take Endofalk?
4. What side effects can cause the application of Endofalk®?
5. How should I store Endofalk?
Qualitative and quantitative composition
1 sachet contains:
Potassium chloride 0.185 g
Sodium chloride 1.400 g
Sodium hydrogen carbonate 0.715 g
Macrogol 3350 52.500 gr

2 sachets dissolved in 1 liter of water contains:
Potassium chloride 0.370 g
Sodium chloride 2.800 g
Sodium hydrogen carbonate 1.430 g
Macrogol 3350 105.000 gr

2 sachets diluted in 1 liter of water correspond to:
Potassium 5 mmol / l
Sodium 65 mmol / l
Chloride 53 mmol / l
Bicarbonate 17 mmol / l
Macrogol 3350 31 mmol / l

Excipients:
Saccharin sodium, orange and strong fruity flavor, colloidal silicon anhydrous.
1. What Endofalk and what is it used?
Endofalk is a white powder for oral solution. Endofalk used for bowel cleansing prior to colonoscopy.
2. What you need to know before taking Endofalk
Endofalk should not apply if:
• have a hypersensitivity (allergy) to some of the drugs contained in Endofalk®, other macrogols or any of the excipients;
• have bowel obstruction or suspected; have narrowing or perforation of the stomach or intestines, or there is a risk of perforation in the region; suffer from irregular emptying of the stomach, severe colitis or dilation of the colon as a result of inflammation / toxic megacolon /;
• your swallowing reflex and vomiting are not functioning properly or have general weakness. Endofalk should not be used in patients unconscious or those prone to choking or aspiration of fluids.
Endofalk be used with caution if:
• suffer from chronic inflammatory bowel disease. Before taking Endofalk You should tell your doctor about these diseases.
• suffer from inflammation of the esophagus caused by reflux of stomach acid / reflux oesophagitis / or abnormal heart rhythm / S-A block or sinus syndrome / or are an elderly patient. If you suffer from these diseases, you should take Endofalk only under medical supervision.
• patients with impaired renal function, heart failure, or severe liver disease and dehydrated patients. Endofalk should not be used in these patient groups, since its safety is not sufficiently established.
Children
Endofalk should not be used in children because of insufficient experience in this age group.
Pregnancy
There is no experience in implementing Endofalk during pregnancy.
Consider carefully the benefit-risk Endofalk can be administered to pregnant women because absorption of macrogol 3350 is extremely low.
Breastfeeding
If necessary Endofalk can be administered to women who are breastfeeding.
Effects on ability to drive and use machines
Endofalk no effect on ability to drive and use machines.
Interactions
If you are taking medicines orally within a few hours before or while taking Endofalk they can be cleaned from the gut and will not be effective. If these drugs are absolutely necessary, ask your doctor about possible alternatives.
Please tell your doctor if you take other medicines, even those without a prescription.
Adoption of Endofalk with food and drink
No other solutions or additional agents (including sugar or colorants, which are not compatible with Endofalk solution) must not add to Endofalk an oral solution because the added substances can alter the osmolality or electrolyte composition or the solution to cause formation of intestinal gas as a result of degradation by intestinal bacteria.
3. How to take Endofalk?
Always take Endofalk according to your doctor's instructions. If you are not sure about the mode of administration, please consult your doctor or pharmacist. For a complete cleansing of the intestines, 3 or maximum 4 liters of solution with Endofalk must be exams.
One sachet corresponds to 1/2 liters of solution. A solution of drink portions 200-300 ml every 10 minutes until the colon is cleared. In general, the cleaning solution is taken about 4 hours prior to testing.
Endofalk a solution can not be accepted the night before the study or if it left a certain amount to be drawn on the morning of the procedure.
You should not take solid food for a period of 2-3 hours before taking the solution to the completion of the study.
Preparation of the solution
* The solution is prepared immediately before use.
The content of 2 sachets were dissolved in 500 ml of warm, cold or boiled water and then more water is added to 1 liter. Once prepared, ready-to-use solution can be stored in the refrigerator to chill, because it is more pleasant for consumption.
Tell your doctor if you notice that the effect of Endofalk is too strong or too weak.
What should you do if you take more than the required amount Endofalk®?
When taking Endofalk observed diarrhea and / or watery stools. If you receive significantly more than the required amount Endofalk can get severe diarrheal syndrome. If this happens you should take fluids and consult your doctor.
What should you do if you take too little or have forgotten to take Endofalk®?
If you take more than the recommended amount Endofalk, your intestines may not be properly cleaned and not being able to conduct the planned research. For this reason, please observe the recommended by your doctor and the instructions in this leaflet.
What you should know if you stopped taking Endofalk prematurely?
If you interrupt or stop taking Endofalk prematurely, your intestines may not be thoroughly cleaned and not being able to conduct the planned research.
4. What side effects can cause the application of Endofalk?
Gastrointestinal disorders
• Very common (> 10%)
Nausea, fullness and bloating.
• Common (> 1% -10%)
Vomiting, abdominal pain and irritation of the anus.
These symptoms are mainly during the ingestion of a relatively large amount of fluid in a short time.
• General disorders
Uncommon (> 0.1% -1%)
Malaise and insomnia.
• Cardiac disorders
Very rare (<0.01%)
Abnormal heart rhythm / arrhythmia, tachycardia / fluid accumulation in the lungs / lung edema /.
Electrolyte and water balance of the patient should be carefully monitored.
• Studies
Very rare (<0.01%)
Some patients may be a decrease in serum calcium.
• Immune System
Very rare (<0.01%)
May occur rash / urticaria / leakage of secretions from the nose / rhinorrhea / or acute inflammation of the skin / dermatitis / probably allergic origin.
Warning:
In the literature are noted two case-Weiss syndrome, Mallory as a result of vomiting following the administration of macrogol-containing wash solutions.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What measures should be taken in relation to side effects?
If develop abdominal pain or other gastrointestinal symptoms taking Endofalk® should be temporarily slowed or stopped until the symptoms disappear. If this occurs, please tell your doctor.
5. How should I store Endofalk?
Keep out of reach of children. Do not use after the expiry date shown on the packaging.
Storage Instructions:
Powder for oral solution: no special storage conditions.
The reconstituted solution can be stored at temperatures below 25 ° C or store up to 48 hours in a refrigerator (2 ° C - 8 ° C).
Packaging Data:
Carton containing 6 sachets containing powder for oral solution