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Norgine Limited
Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS
Telephone: +44 (0)1895 826 600
Fax: +44 (0)1895 825 865
E-mail:
Medical Information e-mail: medinfo@norgine.com

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?
Summary of Product Characteristics last updated on the eMC: 22/03/2011
SPC KLEAN PREP 69g, sachet powder for oral solution

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 22/03/2011 and displayed until Current
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 14/10/2010 and displayed until 22/03/2011
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 07/10/2010 and displayed until 14/10/2010
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 16/03/2010 and displayed until 07/10/2010
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 05/05/2009 and displayed until 16/03/2010
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 04/08/2006 and displayed until 05/05/2009
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:   10/2003
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 01/08/2006 and displayed until 04/08/2006
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:   10/2003
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 22/09/2003 and displayed until 01/08/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 13/08/2001 and displayed until 22/09/2003
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 06/09/1999 and displayed until 13/08/2001
Reasons for adding or updating:
  • No reasons supplied