Last Updated on eMC 22-08-2017 View medicine  | 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.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:10-08-2017

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.2 posology update to include the procedure conducted when you are put under general anaesthesia and without general anaesthesia

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:29-04-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

Section 2 – minor change to the sentence regarding list of excipients.

 

Section 4.2 – addition of the word ‘clinical’ before procedure throughout various paragraphs.

 

Section 4.7 – minor amends to the wording of the sentence regarding ability to use machinery.

 

Section 4.8 – minor amendments to the description of the frequencies.

 

Section 5.3 – update to the information on reproductive toxicology studies.

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 6.6 - Special precautions for disposal and other handling
  • Improved presentation of SPC

Date of revision of text on the SPC:01-07-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Please note the following changes to the  MOVIPREP SMPC

 

 

Section 2          -addition of the title – ‘Excipients with known affect’

 

Section 4.2       -an additional dosing option has been added to include the option of ‘two litres in the morning of the clinical procedure’. Further information around the dosing has been added.

                        -information around the method of administration has been added.

 

Section 4.3       -statement about the hypersensitivity to excipients has been aligned with QRD wording.

 

Section 4.4       -addition of the sentence ‘ The fluid content of Moviprep when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained’

                        -addition of statements regarding those at risk of arrhythmia

                        -addition of statements regarding the content of absorbable sodium, potassium and aspartame in relation to at risk patients.

 

Section 4.6       -general information added about use in pregnancy and breastfeeding.

 

Section 4.8       -the addition of the adverse event  arrhythmia, to cardiac disorders

                        -the order of some adverse events has been amended

                        -addition of the statement  ‘Dehydration may occur as a result of diarrhoea and/or vomiting.’

                        - addition of information regarding adverse event reporting.

 

Section 6.6       -information added to the precautions for disposal

 

Improved presentation of SPC

                        -the spelling of Sulphate has been changed from Sulphate and Sulfate throughout.

                        -MOVIPREP uppercase text has been changed to lowercase text throughout.

 

 

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-06-2012

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8 (undesirable effects), hypokalaemia has been added to investigations
In section 10 (date of revision of the text: chaged from 18/01/2011 to June 2012

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:18-01-2011

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

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:01-07-2010

Legal Category:P

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Introduction of new pack/pack size

Date of revision of text on the SPC:06-08-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Reason for revision – New SmPC / New PIL

 

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:01-07-2010

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.

Reasons for adding or updating:

  • Improved Electronic Presentation

Date of revision of text on the SPC:27-03-2007

Legal Category:P

Black Triangle (CHM): NO

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:01-03-2007

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.

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • New SPC for new product