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:



For the SMPC the following changes have been made.

 

 

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 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 7 - Marketing authorisation holder
  • 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:

Section 2 (Qualitative and quantitative composition), glucose has been replaced with dextrose.

Section 4.8 (undesirable effects), the frequency of adverse reactions have been removed from the begining of the section. Pruritus was added, and oedema was replaced with angioedema; 'population of 591 patients' was changed to 'population of 825 patients'.

The following information was added:

' Addotionally, adverse events reported in postmarketing are included.

The frequency of adverse reactions to MOVIPREP is defined using the following convention:

Very common ≥ 1/10 (≥10%)
Common ≥ 1/100, < 1/10 (≥ 1%, < 10%)
Uncommon ≥1/1000, < 1/100 (≥ 0.1%, <1%)
Rare ≥ 1/10,000, < 1/1,000 (≥ 0.01%, < 0.1%)
Very rare < 1/10,000 (< 0.01%)
Not known (cannot be estimated from the available data)'

The table has been replaced with an updated one (new inforamtion).

Section 5.1 (Pharmacodynamic properties), 'Osmotically acting laxative'  and 'ATC code:' (before A06A D) has been added.

The following information has been added: 'The oral administration of macrogol-based electrolyte solutions causes moderate diarrhoea and results in rapid emptying of the colon.'

The following: '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.'

has been updated to: 'The electrolytes present in the formulation and as well as the supplementary clear liquid intake are included to prevent ensure that there are no clinically significant variations of sodium, potassium or water, and thus reduce no dehydration risk.'


Section 5.3 (Preclinical safety data), the following has been added: 'No studies have been carried out on the genotoxicity, carcinogenicity or toxic effect on reproduction with this product.'

Section 7 ( MA Holder), the address has not changed but has been updated.

Section 10 (Date of revision of the text), 06/08/2010 changed to 1 June 2012

Reasons for adding or updating:

  • Correction of spelling/typing errors

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

Legal Category:P

Black Triangle (CHM): NO

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:P

Black Triangle (CHM): NO