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KLEAN PREP 69g, sachet powder for oral solution

Last Updated on eMC 10-Oct-2016 View document  | Norgine Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 10-Oct-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 01-Sep-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following sections have been updated

 

Section 4.3 – to include a warning about regular intake of fluid.

Section 4.4 – to reference convulsions associated with hyponatremia and confusional state.

Section 4.8 – the addition /removal of various adverse events

 

The spelling of sulphate has changed to sulfate throughout the SmPC.

Updated on 22-Jul-2014 and displayed until 10-Oct-2016

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 01-May-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2.  Administrative changes in line with the current QRD Template

 

Section 3. Pharmaceutical Form “Powder for oral soluation” added to bring in line with QRD Template

 

Section 4.3 Administrative changes in line with the current QRD Template

 

Section 4.4 Updated with the following:

 

The following new information has been added:

“There have been rare reports of serious arrhythmias including atrial fibrillation associated with the use of ionic osmotic laxatives for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbance”.

Advice on what action to take should  Nausea and vomiting occur has been moved from Section 4.8 to Section 4.4

the following warnings have been added “In debilitated patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance, the physician should consider performing a baseline and post-treatment electrolyte, renal function test and ECG as appropriate.

Caution should be used in patients with an impaired gag reflex, reflux  oesophagitis, or diminished levels of consciousness”.

 

Section 4.6  Administrative changes in line with the current QRD Template (Q……………) to include Fertility in the Section heading.

 

Section 4.8  Updated with side effects associated with Cardiac Disorders

 

Section 6.1 Updated to include the amount of Aspartame per sachet.

 

Section 10 Date of Revision updated.

Updated on 22-Mar-2011 and displayed until 22-Jul-2014

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 16-Feb-2011

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section 4.8

Updated on 14-Oct-2010 and displayed until 22-Mar-2011

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 01-Jul-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

KLEANPREP SmPC due to a typo,  Section 4.4 had a typo which has now been corrected in the attached document.

Updated on 07-Oct-2010 and displayed until 14-Oct-2010

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage

Date of revision of text on the SPC: 01-Jul-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SmPC

Update to section 6.4 with respect to the reconstitution of the solution.

Update to section 4.4 and 4.3 to provide further information on special warnings and contraindications.

Update to section 4.8 to include additional adverse events.

Updated on 16-Mar-2010 and displayed until 07-Oct-2010

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC: 01-Sep-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:


SmPC - Section 4.3 & 5.1
Section 4.3 'acute intestinal or gastric ulceration' removed and 'congestive heart failure' added as contra-indications.
 
Section 5.1 more information provided on the pharmacokinetic properties with the following added/removed:

Electrolytes are present in the formulation and are exchanged across the intestinal barrier (mucosa) with serum electrolytes and water to prevent the occurrence of potential clinically significant variations of net electrolyte or net water balance.

 

 

Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defecation.

Updated on 05-May-2009 and displayed until 16-Mar-2010

Reasons for adding or updating:

  • Change to section 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC: 29-Apr-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



5.2. Pharmacokinetic properties

 

Macrogol 3350 is unchanged along the gut.  It is virtually unabsorbed from the gastro-intestinal tract and has no known pharmacological activity. Any macrogol 3350 that is absorbed is excreted via the urine.

Updated on 04-Aug-2006 and displayed until 05-May-2009

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC: 01-Oct-2003

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

6.3     Shelf life - change from 2 years to 3 years
10.     Date of revision of the text - from March 2000 to October 2003

Updated on 01-Aug-2006 and displayed until 04-Aug-2006

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC: 01-Oct-2003

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

6.3  Change in shelf life- changed from 2 to 3 years.
10. Date of revisionof the text- rivised in October 2003

Updated on 22-Sep-2003 and displayed until 01-Aug-2006

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 13-Aug-2001 and displayed until 22-Sep-2003

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Updated on 06-Sep-1999 and displayed until 13-Aug-2001

Reasons for adding or updating:

  • No reasons supplied

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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