Skip to content
SPC Logo

MOVICOL Liquid

Last Updated on eMC 11-Dec-2015 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 11-Dec-2015 and displayed until Current

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 4.4 - 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

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



2        QUALITATIVE AND QUANTITATIVE COMPOSITION


QRD update

4.2       Posology and method of administration


QRD update 'the elderly' have been replaced by 'older people' and subheading 'posology' has been added

4.4       Special warnings and precautions for use

The follwoing has been added:
The fluid content of MOVICOL Liquid Orange when re-constituted with water does
not replace regular fluid intake and adequate fluid intake must be maintained.

4.8       Undesirable effects

Adverse advents have been rearranged according to their system organ class

 

4.9       Overdose

Severe abdominal pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

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 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes have been made to the following sections:

 

2 – addition to the statement - For the full list of excipients, see section 6.1.

 

4.2 – addition of the title -  Method of administration

 

4.3-  addition to the statement re hypersensitivity. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

 

4.6 – Lowercase  text used for the word ‘pregnancy’.

 

 

4.8-  addition of the subheading - Skin and subcutaneous tissue disorders- Erythema has been added . Information regarding the methods of reporting side effects has been added.

 

 

6.6 – Addition of  to the title - Special precautions for disposal

 

10- Revision of the date text

Updated on 17-Jun-2013 and displayed until 25-Sep-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:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.6:

 

The paragraphs on ‘Pregnancy, Lactation and Fertility’ were replaced, 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 is no experience of the use of MOVICOL Liquid Orange flavour during pregnancy. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).

MOVICOL Liquid Orange flavour should not be used during pregnancy unless clearly necessary.

 

Lactation

It is unknown whether MOVICOL Liquid Orange flavour is excreted in human milk. A risk to the suckling child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to

discontinue/abstain from MOVICOL Liquid Orange flavour therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

 

Fertility

There are no data on the effects of MOVICOL on fertility.

 

 

Section 5.3

 

The 2 paragraph was added and 3 paragraph was 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,  although no tests of its effects on reproduction or genotoxicity have been conducted.

 

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:

 

‘25 May 2011’ was changed to ‘May 2013’

 

 

Updated on 29-Jun-2011 and displayed until 17-Jun-2013

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 25-May-2011

Legal Category:P

Black Triangle (CHM): NO

Updated on 24-Jun-2011 and displayed until 29-Jun-2011

Reasons for adding or updating:

  • New SPC for new product

Legal Category:P

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

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?

Active ingredients

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

Legal categories

P - Pharmacy

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue