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KLEAN PREP 69g, sachet powder for oral solution

Last Updated on eMC 30-Sep-2016 View changes  | Norgine Limited Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL 00322/0068.



KLEAN PREP 69g, sachet powder for oral solution

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 bowel
  • you have ileus (loss of muscle tone in the gut)
  • you have gastric retention
  • you have toxic colitis and toxic megacolon
  • you have congestive cardiac failure (Heart Failure)

Warnings and Precautions

The fluid content of Klean-Prep when reconstituted with water does not replace regular fluid intake and adequate fluid intake should be maintained.

If you are in poor health or have a serious medical condition, you should be particularly aware of the possible side effects listed in section 4. Contact your doctor or pharmacist if you are concerned.

You should tell your doctor before taking Klean-Prep if you have any of the following;

  • have a problem swallowing
  • have reflux oesophagitis (which is a condition where acid from the stomach enters the oesophagus (gullet))
  • have reduced levels of consciousness
  • have ulcerative colitis (which is an inflammatory disease of the bowel which can cause abdominal pain and bloody diarrhoea).
  • are prone to regurgitation (which is the return of food from the stomach into the oesophagus (gullet) and mouth) or aspiration (which is breathing in of food and/or fluid into the airways). These patients will need to be carefully monitored during administration.
  • have heart problems including irregular heartbeats or palpitations.
  • have kidney problems

Some patients taking Klean-Prep have developed very low levels of sodium in the blood and as a result may experience convulsions, confusion or disorientation.

Other medicines and Klean-prep

If you are taking other medicines take them at least one hour before taking Klean-Prep or at least one hour afterwards because they may be flushed through your digestive system and not work so well.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as diuretics (that increase the amount of urine passed) and also medicines obtained without a prescription.

Klean-Prep with food and drink

Do not take any solid food for at least two hours before you take Klean-Prep.

Pregnancy, breast-feeding and fertility

There are no data on the use of Klean-Prep during pregnancy or lactation and it should only be used if considered essential by your physician .

So if you are pregnant or breastfeeding, think you may be pregnant or are planning a baby, ask your doctor or pharmacist for advice before taking Klean-Prep.

Driving and using machines

Klean-Prep does not affect your ability to drive or use machines.

Important information about some of the ingredients of Klean-Prep

This medicinal product contains 125mM of absorbable sodium per litre. To be taken into consideration by patients on a controlled sodium diet.

This medicinal product contains 10mM of potassium per litre. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Klean-Prep contains aspartame, which is a source of phenylalanine, this may be harmful to people with phenylketonuria (a genetic disorder affecting metabolism).

3. HOW TO TAKE KLEAN-PREP

Always take Klean-Prep exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

  • The usual dose is up to 4 sachets taken at a rate of 250ml every 10 to 15 minutes until the total volume is consumed or rectal effluent is clear, or as directed by the physician. The solution from all 4 sachets should be drunk within 4 to 6 hours.

If you have a morning appointment at the hospital

  • take Klean-Prep during the afternoon and evening of the day before you appointment. This will take about 4 to 6 hours altogether.

If you have an afternoon appointment,

  • take 2 sachets on the evening before your appointment, and the remaining 2 sachets the next morning. This takes about 2-3 hours each time.

To take Klean-prep:

1. Empty the contents of one sachet of Klean-Prep into 1 litre (1 ¾ pints) of water.
2. Stir until the solution is clear.
3. Drink 1 glassful (¼ litre or ½ pint) of Klean-Prep about every fifteen minutes until you have drunk it all.
4. Make up and take the next sachets in the same way. You should be starting to have watery bowel movements so stay near a toilet. If after three sachets you are passing only clear liquid, there is no need to take the final sachet.

What else do I need to know?

You should start opening your bowels 1 to 2 hours after starting to take Klean-Prep. If you have not had a bowel movement after taking 2 sachets, wait until you go to the toilet before you continue with Klean-Prep. If you have slept the night and still not have had any bowel movements, contact the hospital for advice.

If you take more Klean-Prep than you should, drink lots of liquids especially fruit juices.

If you forget to take Klean-Prep, take the next dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist

4. POSSIBLE SIDE EFFECTS

Like all medicines, Klean-Prep can have side effects, although not everybody gets them.

The following side effects have sometimes been seen but it is not known how often they occur because the frequency cannot be estimated form the available data:

  • Feeling sick, a feeling of fullness in your stomach, bloating and wind may all be experienced. You may experience abdominal cramps, vomiting or soreness of the anus (bottom). If you get a feeling of nausea (feeling sick) swelling of the stomach, or stomach pain, or you start to vomit, you should drink Klean-Prep more slowly or stop drinking it for a few minutes until you feel better.
  • People can be allergic to Klean-Prep, and may get an itchy skin rash (nettle rash or hives) or reddening of the skin. They may also experience swelling of the face, lips, tongue and throat, and may also have difficulty in breathing and become breathless. If you experience any of these reactions you should contact a doctor immediately for advice.
  • A reduction in levels of sodium and potassium in the blood. This is more common in people who are taking medicines which affect the kidneys, such as diuretics
  • Convulsions (fits), confusion/disorentation linked with extremely low levels of sodium in the blood.
  • Dehydration or feeling thirsty
  • Headaches or dizziness
  • Shivering or fever may occur.
  • Malaise (general unwellness)
  • Brief increase in blood pressure that may be linked to bowel preparations. Irregular heartbeats or palpitations.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE KLEAN-PREP

Keep this medicine out of the sight and reach of children.

Store Klean-Prep sachets in a dry place. Do not store above 25°C.

After you have dissolved Klean-Prep in the water, the solution may be stored in the fridge (2°C -8°C). Do not keep it for more than 24 hours.

Do not use this medicine after the expiry date which is stated, after “EXP” on the carton. The expiry date refers to the last day of the month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Klean-Prep contains

The active substances are Macrogol 3350, Sodium Sulphate, Sodium Bicarbonate, Sodium Chloride and Potassium Chloride. Each sachet contains:

Macrogol 3350 59.0g

Sodium Sulfate 5.685g

Sodium Bicarbonate 1.685g

Sodium Chloride 1.465g

Potassium Chloride 0.743g

The other ingredients are aspartame and vanilla flavour.

What Klean-Prep looks like and contents of the pack

Each sachet contains 69g Klean-Prep and 4 sachets come in one box.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is

Norgine Ltd
Moorhall Road
Harefield
Middlesex
UB9 6NS
UK

It is made for Norgine by

Helsinn-Birex Pharmaceuticals Ltd.
County Dublin
Ireland

UK Marketing Authorisation Number: PL 00322/0068

The leaflet was last revised in August 2015

Company contact details

Norgine Limited

Company image
Address

Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS

Fax

+44 (0)1895 825 865

Medical Information e-mail
Telephone

+44 (0)1895 826 600

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate, anhydrous

Legal categories

P - Pharmacy

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