Klean-Prep oral powder 69g sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

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

Available from:

Forum Health Products Ltd

ATC code:

A06AD

INN (International Name):

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

Dosage:

59gram ; 5.685gram ; 1.685gram ; 1.465gram ; 742.5mg

Pharmaceutical form:

Powder for oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01060500; GTIN: 5012748052017

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KLEAN-PREP 69G SACHET POWDER FOR ORAL SOLUTION
Macrogol 3350, Sodium sulphate anhydrous, Sodium bicarbonate, Sodium
chloride and
Potassium chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See Section 4.
If you need the information on this leaflet in an alternative format,
such as large text, or Braille
please ring from the UK: 0800 198 5000 and for Medical Information:
01895 826 606
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 IS IT USED FOR
Klean-Prep is dissolved in water, it is a bowel cleansing agent. This
means it flushes everything
out of your intestines (gut) through a laxative action so that they
are completely empty and clean.
You are taking Klean-Prep because you are going to have one of these
procedures :
 Colonoscopy
 Barium enema
 Gut surgery
For all of these, it is important that your gut is clean so the
procedure is more likely to be a
success.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLEAN-PREP DO NOT TAKE KLEAN-PREP if you suspect or your doctor suspects:
 you are allergic (hypersensitive) to the active substances or any of
the
other
ingredients of Klean-Prep (listed in section 6).
 you have a blockage of the gastrointestinal obstruction or
perforation of the wall of the
2
bowel
 you have ileus (loss of muscle tone in the gut)
 you have ga

Summary of Product characteristics

OBJECT 1
KLEAN PREP 69G, SACHET POWDER FOR ORAL
SOLUTION
Summary of Product Characteristics Updated 10-Oct-2016 | Norgine
Limited
1. Name of the medicinal product
KLEAN-PREP 69g, sachet powders for oral solution.
2. Qualitative and quantitative composition
Each sachet of Klean-Prep contains the following active ingredients:
Macrogol 3350
59.000 g
Anhydrous Sodium
Sulfate
5.685 g
Sodium Bicarbonate
1.685 g
Sodium Chloride
1.465 g
Potassium Chloride
0.7425 g
The content of electrolyte ions per sachet when made up to one litre
of water is as follows:
Sodium
125 mM
Sulfate
40 mM
Chloride
35 mM
Bicarbonate
20 mM
Potassium
10 mM
For the full list of excipients, see 6.1.
3. Pharmaceutical form
Powder for oral solution.
A whitish powder which, when dissolved in water, gives a clear,
colourless solution for oral
administration.
4. Clinical particulars
4.1 Therapeutic indications
For colonic lavage prior to diagnostic examination or surgical
procedures requiring a clean colon, e.g.
colonoscopy, barium enema or colonic resection.
4.2 Posology and method of administration
ADULTS: Each sachet should be dissolved in 1 litre of water. The usual
dose is up to 4 sachets taken at a
rate of 250 ml every 10 to 15 minutes until the total volume is
consumed or rectal effluent is clear, or as
directed by the physician.
The solutions from all 4 sachets should be drunk within 4 to 6 hours.
Alternatively, administration may be
divided, for example, taking 2 sachets during the evening before the
examination, and the remaining 2
sachets on the morning of the examination.
If administration is by nasogastric tube, the usual rate should be 20
to 30 ml/minute.
CHILDREN: There is no recommended dosage.
Renal patients: No dosage adjustment need be made.
4.3 Contraindications
Do not use in patients with known or suspected:
- hypersensitivity to the active substances or to any of the
excipients listed in section 6.1
- gastrointestinal obstruction or perforation
- ileus
- gastric retention
- toxic colitis and toxic megacolon
- congestive cardiac fai