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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: 18/11/2011
SPC MOVIPREP, 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 18/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Jan-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes from the renewal of the marketing authorisation are to sections 1, 6.4, 10:
 
Section 1;

MOVIPREP, powder for oral solution - 'in sachets' has been removed
 
Section 6.4:

Sachets: Store below 25°C. ('Store in the original package' - has been removed).

Reconstituted Solution: Store below 25°C. The solution may be refrigerated. Keep the solution covered. 

 
Section 10: Date of revision of the text 18Jan2011
Updated on 25/10/2010 and displayed until 18/11/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
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
None provided
Updated on 12/10/2010 and displayed until 25/10/2010
Reasons for adding or updating:
  • Introduction of new pack/pack size
Date of revision of text on the SPC:   06-Aug-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Reason for revision – New SmPC / New PIL

 
Updated on 16/08/2010 and displayed until 12/10/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
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
4.8 -

As with other macrogol containing products, allergic reactions including rash, urticaria, pruritus, angioedema and anaphylaxis are a possibility.

Data from clinical studies are available in a population of 825 patients treated with MOVIPREP in which undesirable effect data were actively elicited.  Additionally,  adverse events reported in postmarketing are included.

 

5.1

The physiological consequence is a propulsive colonic transportation of the softened stools.

The electrolytes present in the formulation and the supplementary clear liquid intake are included to prevent clinically significant variations of sodium, potassium or water, and thus reduce dehydration risk.



5.3

No studies have been carried out on the genotoxicity, carcinogenicity or toxic effect on reproduction with this product.
Updated on 28/07/2008 and displayed until 16/08/2010
Reasons for adding or updating:
  • Improved Electronic Presentation
Date of revision of text on the SPC:   27-Mar-2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 17/04/2007 and displayed until 28/07/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

1.        Name of the medicinal product

 

           MOVIPREP, powder for oral solution in sachets

 

5.1       Pharmacodynamic properties

Macrogol 3350, sodium sulphate and high doses of ascorbic acid exert an osmotic action in the gut, which induce a laxative effect.  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 defaecation. The electrolytes present in the formulation as well as the supplementary clear liquid intake ensure that there are no clinically significant variations of sodium, potassium or water, and thus no dehydration risk.

 

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

 

7.       MARKETING AUTHORISATION HOLDER

Norgine BV

Hogehilweg 7, 1101CA

Amsterdam ZO

The Netherlands

 

8.       MARKETING AUTHORISATION NUMBER(S)

PL: 20142/0005

10. DATE OF REVISION OF THE TEXT

 

27/03/2007.
Updated on 05/01/2007 and displayed until 17/04/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 05/01/2007 and displayed until 05/01/2007
Reasons for adding or updating:
  • New SPC for new product