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Movicol 13.8g sachet, powder for oral solution

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 - how to report a side effect
  • 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


The amount of active ingredients has been changed from mg to g

4.2        Posology and method of administration

QRD updates: Inclduing of subheading 'Posology' and 'the elderly' has been changed to 'older people'

4.4        Special warnings and precautions for use


The following sentence has been included:

The fluid content of MOVICOL 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 rearranged according to their system organ class.


4.9        Overdose

Severe abdominal pain or distension can be treated by nasogastric aspiration.

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:P

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 4.8 - 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:



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

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 4.8

Addition of the subheading – Skin and subcutaneous tissue disorders – Erythema has been added.  Information regarding the methods of reporting side effects has been added.

Section 10

Changed to April 2014

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:P

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 07-Jun-2011 and displayed until 17-Jun-2013

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.3 - Preclinical Safety Data

Date of revision of text on the SPC: 05-May-2011

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updated inline with current safety information.

Updated on 01-Dec-2010 and displayed until 07-Jun-2011

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 09-Sep-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Adverse events tabulated.

Updated on 16-Mar-2010 and displayed until 01-Dec-2010

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-May-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:


MOVICOL SPC - Changes to Sections 4.4, 4.5 & 4.8. 

Addition of, of to section 4.4.

The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by MOVICOL (see section 4.5).

Addition of, of to section 4.5

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

Change to section 4.8

Immune System Disorders

 

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

 

Gastrointestinal Disorders

 

Abdominal pain

Abdominal distension

Vomiting

Diarrhoea

Nausea

Flatulence

Borborygmi

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. Mild diarrhoea which usually responds to dose reduction.

 

 

Updated on 16-Aug-2007 and displayed until 16-Mar-2010

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 17-Apr-2007 and displayed until 16-Aug-2007

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

2.      Macrogol 3350 (Polyethylene Glycol 3350)       13.125 g

 

4.1    ………….loading of the rectum and/or colon. confirmed by physical examination of the abdomen and rectum.

4.2    Children below 12 years old: Not recommended. Alternative  Movicol products are available for children.

4.3    Known hypersensitivity to any of these active substances or to any of the excipients. Hypersensitivity to the active ingredients or to any of the excipients.

4.4    Special warnings and precautions for use

         Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

         There is no clinical trial data on the use of Movicol in children, therefore it is not recommended.

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

4.7    There is no effect Movicol has no influence on the ability to drive and use machines.

 

5.1    Pharmacotherapeutic group: Osmotically acting laxatives.

6.1    List of Excipients

         Acesulfame K potassium (E950)

         Lime and lemon flavour*

         (Lime and lemon flavour contains the following constituents: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water).

6.3    Shelf life

         The shelf life of the sachets is 3 years.

         Discard any solution not used within Reconstituted solution: 6 hours.

6.4    Reconstituted solution: Store at 2 - 8°C (in a refrigerator and covered).

6.5    Nature and contents of container

         Sachet: laminate consisting of four layers: low density polyethylene, aluminium, low density polyethylene and paper.

         13.8g sachets contained in Pack sizes: boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.  Not all pack sizes may be marketed.

6.6    Special precautions for disposal

         None. Any unused solution should be discarded within 6 hours.

9       Date of the first authorisation or renewal

         18th December 1995 / March 2001 18th December 2005

10     Date of revision of the text

         August 2002 August 2005 August 2006 March 2007

Updated on 01-Dec-2006 and displayed until 17-Apr-2007

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Sep-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

Section 5.1:

Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces 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. 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:

gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

 Section 10: 12 September 2006

Updated on 08-Sep-2003 and displayed until 01-Dec-2006

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 13-Dec-2002 and displayed until 08-Sep-2003

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Updated on 10-Apr-2002 and displayed until 13-Dec-2002

Reasons for adding or updating:

  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Updated on 08-Apr-2002 and displayed until 10-Apr-2002

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration

Updated on 13-Aug-2001 and displayed until 08-Apr-2002

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration

Updated on 13-Aug-2001 and displayed until 13-Aug-2001

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration

Updated on 13-Aug-2001 and displayed until 13-Aug-2001

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration

Updated on 06-Sep-1999 and displayed until 13-Aug-2001

Reasons for adding or updating:

  • No reasons supplied

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 bicarbonate, sodium chloride

Legal categories

P - Pharmacy

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