Klean-Prep Powder for oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium chloride; Potassium chloride; Macrogol 3350; Sodium bicarbonate; Sodium sulfate anhydrous

Available from:

Helsinn Birex Pharmaceuticals Limited

ATC code:

A06AD; A06AD65

INN (International Name):

Sodium chloride; Potassium chloride; Macrogol 3350; Sodium bicarbonate; Sodium sulfate anhydrous

Dosage:

Per Cent

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Marketed

Authorization date:

1988-06-30

Patient Information leaflet

21
0008.10/2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
KLEAN-PREP®
POWDER FOR ORAL SOLUTION
59g Macrogol 3350, 5.685g sodium sulphate, 1.685g sodium bicarbonate,
1.465g sodium chloride and
0.7425g potassium chloride.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU

Keep this leaflet. 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 pass it on to
others. It may harm them,
even if their symptoms are the same as yours.

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 Klean-Prep is and what it is used for
2.
What you need to know before you take Klean-Prep
3.
How to take Klean-Prep
4.
Possible side effects
5.
How to store Klean-Prep
6.
Contents of the pack and other information
1.
WHAT KLEAN-PREP IS AND WHAT IT IS USED FOR
Klean-Prep contains an ingredient called ‘Macrogol’ and a mixture
of salts. It comes as a powder that
you dissolve in water to make a drink.
Klean-Prep is used:

To empty your bowel before a medical examination or bowel surgery

As a laxative for short-term relief of constipation
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLEAN-PREP
DO NOT TAKE KLEAN-PREP IF:

You are allergic (hypersensitive) to Macrogol or any of the other
ingredients of this medicine
(listed in Section 6)

You have heart failure

You have severe kidney problems

You have an inflamed gut (toxic colitis)

You have a stomach ulcer, or any ulcers in your gut

Your gut has suddenly become bloated (toxic megacolon)

You have an obstructed bowel or a hole in your bowel (perforated
bowel)

You have a gut problem where your gut contents move more slowly
(ileus)

Your stomach contents are not passing through to the gut properly
(gastric retention)

You weigh less than 20kg
Do not t

Summary of Product characteristics

Health Products Regulatory Authority
18 October 2021
CRN00CL6Y
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Klean-Prep Powder for oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Macrogol 3350
59.0000 g
Sodium Sulphate Anhydrous
5.6850 g
Sodium Bicarbonate
1.6850 g
Sodium Chloride
1.4650 g
Potassium Chloride
0.7425 g
Aspartame (E951)
0.0494 g
WHEN THE CONTENTS OF A SACHET ARE RECONSTITUTED WITH ONE LITRE OF
WATER, THE RESULTING SOLUTION CONTAINS:
Sodium
125 mmol/l
Potassium
10 mmol/l
Sulphate
40 mmol/l
Chloride
35 mmol/l
Bicarbonate
20 mmol/l
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution.
A white granular powder for oral solution which on reconstitution
gives a clear colourless solution with a characteristic flavour
of vanilla.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For gastrointestinal lavage and preparation prior to diagnostic
examination or surgery particularly for the large bowel. For use
as a short term laxative in cases of constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
RECOMMENDED DOSAGE
ADULTS ONLY:
FOR GASTROINTESTINAL LAVAGE AND PREPARATION PRIOR TO DIAGNOSTIC
EXAMINATION OR SURGERY:
To reconstitute, dissolve the entire contents of one sachet of
Klean-Prep in 1000ml of water, stirring in order to aid dissolution.
The usual dose of Klean-Prep is 4 litres of the reconstituted solution
(four sachets) consumed at a rate of 200-250 ml every ten
to fifteen minutes until either the rectal effluent appears clear, or
the total volume of 4 litres is consumed. The required
quantity of solution may be taken the evening prior to the split as
follows: 2 litres the evening before the procedure followed
by up to 2 litres on the morning of the procedure.
It is recommended that no food be consumed for at least 2 hours prior
to taking Klean-Prep until after the completion of any
related diagnostic or surgical procedure.
Health Products Regulatory Authority
18 October 2021
CRN00CL6Y
Page 2 of 5
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