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MOVICOL-Half

Last Updated on eMC 06-Apr-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 06-Apr-2016 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 - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 31-Jul-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



2          QUALITATIVE AND QUANTITATIVE COMPOSITION

This section is now referring to substances as opposed to ingredients

 

4.2       Posology and method of administration

 

A subheading ‘Posology’ has been inserted

 

4.4       Special warnings and precautions for use

 

The following sentence was included:

The fluid content of MOVICOL Half  when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained

 

4.8       Undesirable effects

 

Adverse events have been re-arranged

 

10        DATE OF REVISION OF THE TEXT

 

July 2015

Updated on 30-Sep-2014 and displayed until 06-Apr-2016

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 4.8 - 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:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Please not the following sections have been updated:

Section 2.

Present:           For excipients see 6.1

Changed to:      For full list of excipients  see section 6.1

 

Section 4.2

Present heading:          Administration

Changed heading to:     Method of administration

 

Section 4.3

 

Present:             Contraindications

Changed to:        Contra-indications

 

Present:           Known hypersensitivity to any active substances or excipients

Changed to :     Known hypersensitivity to any active substances or excipients listed in 6.1

 

Section 4.8

Table and reporting of adverse events updated to:

 

 

System  Organ Class

Adverse Event

Immune system disorders

Allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, urticaria, and pruritus.

Skin and subcutaneous tissue disorders

Erythema

Metabolism and nutrition disorders

Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.

Nervous system disorders

Headache

Gastrointestinal disorders

Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence and anorectal discomfort.

General disorders and administration site conditions

Peripheral oedema.

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

 

 

Section10

 

Revision of text changed from July 2013 to April 2014

Updated on 27-Aug-2013 and displayed until 30-Sep-2014

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-Jul-2013

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Changes as follows:

 

Section 4.6:

 

The paragraph on ‘Pregnancy and lactation’ as follows:

 

4.6          Pregnancy and lactation

 

‘There is no experience of the use of MOVICOL-Half during pregnancy and lactation and it should only be used if considered essential by the physician.’

 

was replaced by the following:

 

4.6. Fertility, pregnancy and lactation

 

‘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 Half 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 Half 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). ‘

 

 

Currently approved 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. 

 

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 macrogols that provide evidence of safety at the recommended therapeutic dose.’

 

 

Section 10:

 

‘Approved: October 2011’ was changed to ‘July 2013’

 

Updated on 22-Aug-2012 and displayed until 27-Aug-2013

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Oct-2011

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.4 (Special warnings and precautions for use): addition of the following paragraph: 'The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by MOVICOL-Half (see section 4.5).'

In section 4.5 (Interaction with other medicinal products and other forms of interaction): removal of the following: 'Clinical interactions with other drugs have been reported extremly rarely.' (...) 'There is therefore a theoretical possibility that the absorption of such medical products could be transiently reduced.'

Addition of the following: 'There is a possibility that the absorption of other medicinal products could be transiently reduced during use with MOVICOL-Half (see section 4.4).There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.'


In section 4.8 (Undesirable effects): removal of the following: abdominal pain, nausea, borborygmi, diarrhoea, abdominal distension, vomiting, flatulence, anal discomfort, allergic reactions, including anaphylaxis, pruritus, utricaria and dyspnoea.

Addition of undesirable effects presented in a table.

Updated on 27-Jan-2009 and displayed until 22-Aug-2012

Reasons for adding or updating:

  • 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-Jan-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.5           Interaction with other Medicinal Products and other forms of Interaction

 

…..absorbed.

 

Clinical interactions with other drugs have been reported extremely rarely. No specific reactions with individual drugs or classes of drugs have been observed.

 

Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.  There is therefore a theoretical possibility that the absorption of such medicinal products could be transiently reduced.

 

4.8.           Undesirable Effects

 

Reactions related to the gastrointestinal tract are the most common to occur.  These may include:

 

Abdominal pain

Nausea

Borborygmi

Diarrhoea

Abdominal distension

Vomiting

Flatulence

Anal discomfort

 

These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of MOVICOL-Half. Mild diarrhoea usually responds to dose reduction.

 

Allergic reactions, including anaphylaxis. Other symptoms of allergic reactions include pruritus, urticaria and dyspnoea.

10. Date of (Partial) Revision of the Text

 

Approved: January 2009

Updated on 01-Nov-2007 and displayed until 27-Jan-2009

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC: 01-Oct-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.1
Deletion of:
The electrolytes also present in the formulation also ensure that there is virtually no net gain or loss of sodium, potassium or water.  The lacative action of macrogol 3350 has a time course which will vary according to the severity of the consitpation or faecal impaction being treated.
 
And replaced with:
Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways.  The phyisological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the defaecation.  Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium and water.
 
Section 5.2
Deletion of:
'and has no known pharmacological activity.'
 
 
 

Updated on 07-Sep-2004 and displayed until 01-Nov-2007

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text

Updated on 04-Sep-2003 and displayed until 07-Sep-2004

Reasons for adding or updating:

  • New SPC for new product

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 bicarbonate, sodium chloride

Legal categories

P - Pharmacy

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