MOVICOL PAEDIATRIC PLAIN 6.9g sachet, powder for oral solution *
Pharmacy Only: Prescription

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 May 2021

File name

ie-smpc-mov-pedpl-clean_1621495399.pdf

Reasons for 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Movicol Paediatric Plain contains 93.4 mg (4.062 mmol) sodium (main component of cooking/table salt) per sachet. This is equivalent to 4.6% of the recommended maximum daily dietary intake of sodium for an adult.

In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section 4.5.

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

MOVICOL Paediatric Plain may result in a potential interactive effect if used with starch-based food thickeners. Macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

10        DATE OF REVISION OF THE TEXT

26 February 2021 17 May 2021

Updated on 20 May 2021

File name

ie-pil-mov-pedpl-clean_1621495142.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to name of medicinal product

Free text change information supplied by the pharmaceutical company

  1. What you need to know before you give Movicol Paediatric Plain

Some medicines, e.g. anti-epileptics, may not work as effectively during use with Movicol Paediatric Plain. When taking large volumes of Movicol Paediatric Plain (e.g. for faecal impaction), your child should not take other medicines within one hour of taking Movicol Paediatric Plain.

If you need to thicken fluids in order to swallow them safely, Movicol Paediatric Plain may counteract the effect of the thickener.

  1. Contents of the pack and other information

This medicinal product is authorised in the Member States of the EEA under the following names

Germany                                              Macrogol Norgine Junior Neutral Pulver zur Herstellung einer Lösung zum Einnehmen

This leaflet was last revised in 042/2021

Updated on 01 March 2021

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ie-smpc-mov-pedpl-clean_1614610527.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

6.4.      Special precautions for storage

Sachet: Do not store above 25°C.  This medicinal product does not require any special storage conditions.

 

10      DATE OF REVISION OF THE TEXT

20 May 2020 26 February 2021

Updated on 01 March 2021

File name

ie-pil-mov-pedpl-clean_1614610218.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

 

 

5.         How to store Movicol Paediactric Plain

 

Do not store your MOVICOL Paediactric Plain above 25°C.  This medicinal product does not require any special storage conditions.

 

Once you have made up Movicol Paediactric Plain in water, if you cannot drink it straight away keep it covered and in the fridge (2°C – 8°C). Throw away any solution not used within a 6 hour period.

 

6.         Contents of the pack and other information

 

This leaflet was last revised in 05/2020 02/2021

 

Other sources of information

If you need the information on this leaflet in an alternative format, such as large print, or Braille please ring 0800 198 5000.

Updated on 21 May 2020

File name

ie-smpc-mov-pedpl-clean_1590062999.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.1       Therapeutic indications

For the treatment of chronic constipation in children 1 to 11 years of age.

 For the treatment of faecal impaction in children from the age of 5 years, defined as refractory constipation with faecal loading of the rectum and/or colon.

4.2       Posology and method of administration

            Posology

Chronic constipation

The usual starting dose is 1 sachet daily for children aged 1 to 6 years, and 2 sachets daily for children aged 7 to 11 years. The dose should be adjusted up or down as required to produce regular soft stools. If the dose needs increasing this is best done every second day. For children below 2 years of age, the maximum recommended dose should not exceed 2 sachets a day. For children aged 2 to 11 years, the maximum recommended dose needed does not normally exceed 4 sachets a day.

Treatment of children with chronic constipation needs to be for a prolonged period (at least 6 – 12 months). However, safety and efficacy of Movicol Paediatric Plain has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs.

Faecal impaction

A course of treatment for faecal impaction with Movicol Paediatric Plain is for up to 7 days as follows:

Daily dosage regimen:

Number of MOVICOL Paediatric Plain sachets

Age (years)

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

5 - 11

4

6

8

10

12

12

12

 

The daily number of sachets should be taken in divided doses, all consumed within a 12 hour period.  The above dosage regimen should be stopped once disimpaction has occurred. An indicator of disimpaction is the passage of a large volume of stools. After disimpaction it is recommended that the child follows an appropriate bowel management program to prevent reimpaction (dosing for prevention of re-impaction should be as for patients with chronic constipation; see above). 

Movicol Paediatric Plain is not recommended for children below 5 years of age for the treatment of faecal impaction, or in children below 1 year of age for the treatment of chronic constipation. For patients of 12 years and older it is recommended to use Movicol.

 Patients with impaired cardiovascular function:

There are no clinical data for this group of patients. Therefore Movicol Paediatric Plain is not recommended for treating faecal impaction in children with impaired cardiovascular function.

 Patients with renal insufficiency:

There are no clinical data for this group of patients. Therefore Movicol Paediatric Plain is not recommended for treating faecal impaction in children with impaired renal function.

 Method of administration

Each sachet should be dissolved in 62.5 ml (quarter of a glass) of water. The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 24 hours. For example, for use in faecal impaction, 12 sachets can be made up into 750 ml of water.

 

4.8 Undesirable effects

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 HPRA Pharmacovigilance Website: www.hpra.ie

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

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.

 

In an open study of Movicol in chronic constipation, weekly defaecation frequency was increased from 1.3 at baseline to 6.7, 7.2 and 7.1 at weeks 2, 4 and 12 respectively. In a study comparing Movicol and lactulose as maintenance therapy after disimpaction, weekly stool frequency at the last visit was 9.4 (SD 4.46) in the Movicol group compared with 5.9 (SD 4.29). In the lactulose group 7 children re-impacted (23%) compared with no children in the Movicol group.

 

In one retrospective-prospective study, 35 patients <24 months age were treated with MOVICOL for functional constipation for a mean duration of 4.6 ± 3.67 months (from 3 weeks to 18 months).   Mean stool frequency before treatment was 2.34 ± 0.98 per week. Following treatment, the frequency of bowel movements was 7.31 ± 1.60 per week, which was a significant difference from baseline (p < 0.001). There was also a significant difference in improvement from baseline in the stool consistency score after treatment (1.57 ± 0.54 vs. 3.34 ± 0.58; p < 0.001).

 

In an observational, prospective, longitudinal, parallel group study 62 children aged 1-17 years were treated for chronic constipation with Macrogol / MOVICOL for 12 weeks.  Of these 62 patients 30 were aged 1 - 3 years.  The number of bowel movements per week was similar in both groups at weeks 6 and 12: mean (SD) 6.1 (2.5) and 6.0 (2.7) at 6 weeks, and 4.6 (2.2) and 5.4 (1.8) at 12 weeks for Macrogol and MOVICOL. Similar improved efficacy results were observed in 2 further trials where patients 6 months – 15 years were treated with Macrogol plus electrolytes.

 

For the indication of faecal impaction comparative studies have not been performed with other treatments (e.g. enemas). In a non-comparative study in 63 children, Movicol (Paediatric) cleared the faecal impaction in the majority of patients within 3 - 7 days of treatment. For the 5 - 11 years age group the average total number of sachets of Movicol Paediatric required was 47.2.

6.6       Special precautions for disposal

Any unused solution should be discarded within 24 hours.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

10      DATE OF REVISION OF THE TEXT

20 May 2020

Updated on 21 May 2020

File name

ie-pil-mov-pedpl-clean_1590062704.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 15 January 2020

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ie-pl-movicolpaedplain-21716 - Jan 2020 v2.0_1579086708.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

PIL revised t include removal of Switzerland from list of Member States.

Updated on 07 January 2020

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ie-pl-movicolpaedplain-21716 - Jan 2020_1578415562.pdf

Reasons for updating

  • Addition of manufacturer

Updated on 10 October 2019

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ie-pl-movicolpaedplain-19207-Oct 2019_1570699488.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 04 October 2019

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ie-spc-movicolpaedplain-19207-Oct 2019_1570197650.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 October 2019

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ie-pl-movicolpaedplain-19207-Oct 2019_1570197599.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 23 May 2019

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ie-pl-movicolpaedplain-May 2019-16852_1558540061.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to MA holder contact details

Updated on 21 January 2019

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ie-pl-movicolpaedplain-7890, 16121, & 10833-Dec-2018_1548080462.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 January 2019

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ie-smpc-movicolpaedplain-7890, 10833, 16121-Dec-2018_1548081452.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 February 2017

File name

PIL_11166_641.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 February 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 19 January 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 18 January 2016

Reasons for 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2.         Qualitative and Quantitative Composition

The word ‘ingredients’ has been replaced by the word ‘substances’ as follows:

Each sachet of MOVICOL Paediatric Plain contains the following active substances:

Amendments to the weight i.e. prefixed with 0 where necessary and ‘mg’ replaced by ‘g’

 

4.2       Posology and method of administration

The insertion of the title ‘Posology’ as a heading beneath the main heading above.

 
4.4          Special warnings and precautions for use

The fluid content of MOVICOL Paediatric Plain when re-constituted with water does

not replace regular fluid intake and adequate fluid intake must be maintained.

 

4.8 Undesirable Effects

Updated as follows for the 1st two Classes:

System Organ Class

Frequency

Adverse event

Immune system disorders

Rare

Allergic reactions including anaphylactic reaction..

Not known

Dyspnoea and skin reaction (see below).

Skin and subcutaneous tissue disorders

Not Known

Allergic skin reactions including angioedema, urticarial, pruritus, rash, erythema.

 

10        DATE OF REVISION OF THE TEXT

 

January 2016

Updated on 18 January 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 May 2015

Reasons for 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 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company


Section 2 – deletion of the statement - For the full list of excipients, see section 6.1.

 

Section 4.2 – addition of the title -  Method of Administration

 

Section 4.4  - Addition of ‘Paediatric Plain’ to the product name

 

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 8.0 - Addition of the letter ‘s’ to the title  ‘MARKETING AUTHORISATION NUMBER(S)’

 

Section 10- Revision of the date text

 

 

Updated on 14 May 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to dosage and administration
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 05 July 2013

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 June 2013

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

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 17 June 2013

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 26 November 2012

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.6 (Fertility, pregnancy and lactation) updated inforamtion on pregnancy and breastfeeding, as follows:
'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. '

In section 5.3 (Preclinical safety data) the following information have been added:
'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. '

In section 9 (Date of first authorisation/renewal of the authorisation) the current date (24 September 2003) has been replaced with the following:
'Date of first authorisation: 27 January 2006
Date of last renewal: 23 September 2008'

In section 10 (Date of revision of the text) 09/09/2010 has been replaced with May 2011

Updated on 13 December 2010

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.5,  the following statement was added, "There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics."

In section 4.8, the adverse events were classified according to MeDRA.

In section 7, the address of the MAH was amended.

Updated on 09 December 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 07 July 2008

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 04 December 2006

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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.  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 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.

 Section 5.2:

Macrogol 3350 is unchanged along the gut.  It is virtually unabsorbed from the gastrointestinal tract and has no known pharmacological activity.  Any

 Section 10:  Nov 2006

Updated on 02 August 2006

Reasons for updating

  • New PIL for new product

Updated on 31 July 2006

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)