Endofalk powder for oral solution

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Macrogol 3350; Potassium chloride; Sodium chloride; Sodium bicarbonate

थमां उपलब्ध:

Dr. Falk Pharma GmbH

ए.टी.सी कोड:

A06AD; A06AD65

INN (इंटरनेशनल नाम):

Macrogol 3350; Potassium chloride; Sodium chloride; Sodium bicarbonate

डोज़:

AP gram(s)

फार्मास्यूटिकल फॉर्म:

Powder for oral solution

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Osmotically acting laxatives; macrogol, combinations

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2004-03-25

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENDOFALK® POWDER FOR ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you
-
Keep this leaflet. You may need to read it again
-
Ask your doctor or pharmacist if you need more information or advice.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Endofalk is and what it is used for
2.
What you need to know before you take Endofalk
3.
How to take Endofalk
4.
Possible side effects
5.
How to store Endofalk
6.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENDOFALK
DO NOT TAKE ENDOFALK IF YOU HAVE:

An allergy to macrogol 3350, sodium chloride, sodium hydrogen
carbonate,
potassium chloride or any of the other ingredients of this medicine
(listed in section
6).

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.

उत्पाद विशेषताएं

Health Products Regulatory Authority
02 December 2020
CRN009Y28
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Endofalk powder for oral solution
2 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 g
1 LITRE RECONSTITUTED SOLUTION CONTAINS:
Potassium chloride 0.370 g
Sodium chloride 2.800 g
Sodium hydrogen carbonate 1.430 g
Macrogol 3350 105 g
1 LITRE RECONSTITUTED SOLUTION CORRESPONDS TO:
Potassium 5 mmol/l
Sodium 65 mmol/l
Chloride 53 mmol/l
Hydrogen carbonate 17 mmol/l
Macrogol 3350 31 mmol/l
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution
White powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For emptying the bowel before colonoscopy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For complete cleansing of the bowel 3 or a maximum of 4 litres
Endofalk solution have to be consumed_._ 1 sachet is equivalent
to ½ litre of solution.
Method of administration
The solution is drunk in portions of 200 - 300 ml every 10 minutes
until the rectal outflow is clear. The solution is taken over a
period of about 4 hours, generally on the day of the investigation.
Alternatively, the entire quantity can be given on the
previous evening, or part on the previous evening and the remainder in
the morning of the examination day.
The patient should not eat any solid food from 2 - 3 hours before
administration of Endofalk until after the examination.
Paediatric population
There is no sufficient experience with the use of Endofalk in
children. Therefore Endofalk should not be administered in
children.
Health Products Regulatory Authority
02 December 2020
CRN009Y28
Page 2 of 5
_PREPARATION OF SOLUTION_
The solution should be freshly prepared immediately before use.
Dissolve the contents of 2 sachets in 500 ml of lukewarm
tap-water or cooled boiled water. Subsequently dilute to 1 litre with
water. Care should be taken that the sac