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MOVICOL Plain 13.7g 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 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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:



4.2       Posology and method of administration


QRD updates: inclusion of subheading 'posology' and change 'the elderly' to 'older people'

4.4       Special warnings and precautions for use

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

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
  • Change to section 6.3 - Shelf life

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The following changes have been made to the SmPC:

Section 6.3 – Shelf life

Reconstituted solution from 6 hours to 24 hours

 

Section 10

Revision date from March 2015 to June 2015

Updated on 28-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 - how to report a side effect
  • 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

Deletion of the statement – For excipients see Section 6.1

Section 4.2

Addition of the title “Method of administration

Section 4.3

Changes to the statement re hypersensitivity.

Section 4.8

Addition of the subheading – Skin and subcutaneous tissue disorders – Erythema and ‘anorectal’ has been added.  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 28-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:

 

‘05/05/2011’ was changed to ‘May 2013’

Updated on 22-Nov-2011 and displayed until 17-Jun-2013

Reasons for adding or updating:

  • 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: 05-May-2011

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 9; 'Date of last renewal: 25 January 2011' - has been added.

Updated on 07-Jun-2011 and displayed until 22-Nov-2011

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 08-Dec-2010 and displayed until 07-Jun-2011

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

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:

Section 4.5 updated to include statement with respect to reduced efficacy eith concomitantly administered medicinal products e.g. anti-epileptics.

Section 4.8 updated with tabulated results of the adverse events.

Updated on 16-Mar-2010 and displayed until 08-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:



SPC - Changes to Sections 4.4, 4.5 & 4.8. 

Updated on 19-Jan-2009 and displayed until 16-Mar-2010

Reasons for adding or updating:

  • 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 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 10 date of revision of the text

Date of revision of text on the SPC: 05-Nov-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



2.

following active ingredients:

Macrogol (Polyethylene Glycol) 3350

13.1250 g

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

4.2       Posology and method of administration

Children (below 12 years old): Not recommended. Alternative MOVICOL products are available for children.

Children (below 12 years old): Not recommended. Alternative MOVICOL products are available for children.

4.3       Contraindications

Known hHypersensitivity to any of the active substancesingredients 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.

4.5       Interaction with other medicinal products and other forms of interaction

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       Effects on ability to drive and use machines

There MOVICOL Plain has no influence is no effect on the ability to drive and use machines.

5.1       Pharmacodynamic properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

6.3       Shelf life

The shelf life of the sachets is 3 years. 

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

6.4       Special precautions for storage

Sachet:  Do not store above 25°C.

Reconstituted sSolution: Store at 2-8ºC (in a refrigerator and covered)

6.5       Nature and contents of container

Each sachet contains 13.7 g of powder.

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

13.7g sachets contained inPack sizes:  .

6.6       Special precautions for disposal

None.Any unused solution should be discarded within 6 hours

10      DATE OF REVISION OF THE TEXT

09 March 20075 Nov 2008

Updated on 13-Aug-2007 and displayed until 19-Jan-2009

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-Mar-2007

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

5.1    Pharmacodynamic properties

ATC code: A06A D65

Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect.  The electrolytes also present in the formulation ensure that there is virtually no net gain or loss of sodium, potassium or water.  The laxative action of macrogol 3350 has a time course which will vary according to the severity of the constipation or faecal impaction being treated. 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.

5.2    Pharmacokinetic properties

Macrogol 3350 is unchanged along the gut.  It is virtually unabsorbed from the gastro-intestinal tract and has no known pharmacological activity.  Any macrogol 3350 that is absorbed is excreted via the urine.

 

10      DATE OF REVISION OF THE TEXT

09 March 2007

Updated on 22-Feb-2007 and displayed until 13-Aug-2007

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

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Active ingredients

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

Legal categories

P - Pharmacy

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