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MOVICOL Paediatric Chocolate flavour

Last Updated on eMC 30-Sep-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 30-Sep-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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-Jun-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following sections have been updated

 

Section 2 – to include the excipient level of benzyl alcohol

 

Section 4.4 – to include a warning about benzyl alcohol and its potential to cause anaphylactic reactions.

 

Section 6.1 – to add benzyl alcohol to the list of excipients

 

Section 10 – date of revision - June 2016

Updated on 11-Dec-2015 and displayed until 30-Sep-2016

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC: 24-Oct-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



2        QUALITATIVE AND QUANTITATIVE COMPOSITION


QRD update and amount of active ingredients has been changed from mg to g

4.2       Posology and method of administration


Subhaeding 'posology' has been added

4.4              Special warnings and precautions for use

The follwoing sentence has been added:
The fluid content of MOVICOL Paediatric Chocolate Flavour when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained.4.8             

4.8     Undesirable effects

Adverse events have been rearranged according to their system organ class

10      DATE OF REVISION OF THE TEXT

October 2015

Updated on 25-Sep-2015 and displayed until 11-Dec-2015

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following update has been made to the SmPC:

 

Section 10

Revision date is March 2015

Updated on 24-Apr-2015 and displayed until 25-Sep-2015

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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-Apr-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes have been made to the following sections:

 

Section 2

Addition to the statement – For the full  list of excipients, see Section 6.1

Section 4.2

Addition of the title “Method of administration

Addition of ‘chocolate flavour’ to the name of the product

Section 4.3

Addition to the statement re hypersensitivity.  Hypersensitivity to the active substances or to any of the excipients listed in Section 6.1.

Section 4.5

Deletion of the ‘s’ in the word ‘interactions in the title – “Interaction with other medicinal products and other forms of interaction

Section 4.8

Addition of the subheading – Skin and subcutaneous tissue disorders – Erythema has been added.  Addition of ‘anorectal’ discomfort.

Information regarding the methods of reporting side effects has been added.

Section 10

Revision of the date text

 

Updated on 17-Jun-2013 and displayed until 24-Apr-2015

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation
  • 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: 01-May-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.6:

 

The paragraph on ‘Pregnancy’ was replaced and the paragraph on ‘Fertility’ was added, as follows:

 

Pregnancy

 

There are limited amount of data from the use of MOVICOL in pregnant women.  Studies in animals have shown indirect reproductive toxicity (see section 5.3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.

 

MOVICOL can be used during pregnancy.

 

 

Breastfeeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible.

 

MOVICOL can be used during breast-feeding.

 

 

Fertility

There are no data on the effects of MOVICOL on fertility in humans. There were no effects on fertility in studies in male and female rats (see section 5.3).

 

Previous information in section 4.6:

Pregnancy

There are no or limited amount of data from the use of MOVICOL in pregnant women.  Studies in animals have shown reproductive toxicity (see section 5.3).

 

Breastfeeding

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Macrogol 3350 is negligible

 

MOVICOL can be used during breast-feeding. ‘

 

 

Section 5.3

 

The 2 and 3 paragraph were replaced (as highlighted in red), as follows:

 

‘Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity. 

 

There were no direct embryotoxic or teratogenic effects in rats even at maternally toxic levels that are a multiple of 66 x the maximum recommended dose in humans for chronic constipation and 25 x for faecal impaction. Indirect embryofetal effects, including reduction in fetal and placental weights, reduced fetal viability, increased limb and paw hyperflexion and abortions, were noted in the rabbit at a maternally toxic dose that was 3.3 x the maximum recommended dose in humans for treatment of chronic constipation and 1.3 x for faecal impaction. Rabbits are a sensitive animal test species to the effects of GI-acting substances and the studies were conducted under exaggerated conditions with high dose volumes administered, which are not clinically relevant. The findings may have been a consequence of an indirect effect of MOVICOL related to poor maternal condition as the result of an exaggerated pharmacodynamic response in the rabbit. There was no indication of a teratogenic effect.

 

There are long-term animal toxicity and carcinogenicity studies involving macrogol 3350. Results from these and other toxicity studies using high levels of orally administered high molecular weight macrogols provide evidence of safety at the recommended therapeutic dose.’

 

 

Previous information in section 5.3:

‘Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity. 

 

Indirect embryofoetal effects were noted in the rabbit at clinically relevant doses. Treatment caused an increased incidence of malrotated limbs, reduction in foetal and placental weights, reduced foetal viability and abortions at maternally toxic doses.  The safety margin was 1.1 x the maximum recommended dose for faecal impaction in a 60 kg adult for malrotated limb and 2.9 x below the maximum recommended dose for the remaining findings.  Rabbits are sensitive animal test species to the effects of GI acting substances and the studies were conducted under exaggerated conditions with administered high dose volumes. The relevance of these findings to humans is unknown.

 

There are no long-term animal toxicity or carcinogenicity studies involving macrogol 3350, although there are toxicity studies using high levels of orally administered high molecular weight macrogols that provide evidence of safety at the recommended therapeutic dose.’

 

 

Section 10:

 

‘May 2011’ was changed to ‘May 2013’

Updated on 20-Sep-2012 and displayed until 17-Jun-2013

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

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

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Active ingredients

macrogol 3350, potassium chloride, sodium chloride, sodium hydrogen carbonate

Legal categories

POM - Prescription Only Medicine

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