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MOVICOL Paediatric Plain 6.9 g 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

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



2        QUALITATIVE AND QUANTITATIVE COMPOSITION


QRD update and amount of active ingredients has been changed from mg to g

4.2       Posology and method of administration



Subheading 'posology' has been added

4.4             
Special warnings and precautions for use


The following sentence has been added:
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

Adverse evenst have been rearranged according to their system organ class

 

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:POM

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 07-May-2015 and displayed until 25-Sep-2015

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 4.8 - Undesirable effects
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC: 01-Apr-2014

Legal Category:POM

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 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 17-Jun-2013 and displayed until 07-May-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:POM

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:POM

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
  • Change to section 7 - Marketing Authorisation Holder

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Adverse events tabulated.

Norgine address details amended.

Updated on 15-Mar-2010 and displayed until 01-Dec-2010

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 6.2 - Incompatibilities

Date of revision of text on the SPC: 01-May-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SPC - Changes to Sections 2, 4.4, 4.5, 4.8 & 6.2 

Section 2
Change in name of sodium bicarbonate to sodium hydrogen carbonate

Section 6.2
Change from 'None are known' to 'Not applicable.

Section 4.4
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 Paediatric Plain (see section 4.5).


Section 4.5
Addition of the following paragraph:

There 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.

Deletion of the following:

No clinical interactions with other medicinal products have been reported.


Section 4.5
Addition of the following:

Reactions related to the gastrointestinal tract are the most common to occur. 

Immune system disorders:

Rare: allergic reactions, including anaphylaxis.

Other symptoms of allergic reactions include pruritus, urticaria and dyspnoea


Updated on 01-Apr-2008 and displayed until 15-Mar-2010

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Mar-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

7.   Norgine Pharmaceuticals Limited
 
8.   PL 00322/0083 PL 20011/0005
 
10.   March 2008

Updated on 01-Dec-2006 and displayed until 01-Apr-2008

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-Nov-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.  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:

gastrointestinal tract and has no known pharmacological activity.  Any macrogol 3350 that is absorbed is excreted via the urine.

 Section 10:  15 November 2006

Updated on 31-Jul-2006 and displayed until 01-Dec-2006

Reasons for adding or updating:

  • Change to section 1 - trade name
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

1. Name of the midicinal product-MOVICOL® Paediatric Plain 6.9 g sachet, powder for oral solution.
4.1  Therapeutic indications- deletion of confirmed by physical or radiological examination of the abdomen and  rectum.  For the prevention of the recurrence of faecal impaction in children.
4.2  Posology and method of administration-  Chronic constipation and prevention of re-impaction

The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 – 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.  The maximum dose needed does not normally exceed 4 sachets a day.

Treatment of children with chronic constipation needs to be or a prolonged period (a 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). 

The dosage regimen for faecal impaction is based on one clinical trial.

4.3  Contraindications- Known Hypersensitivity to any of the ingredients active substances.
4.4  Special warnings and precautions for use -

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

Mild adverse drug reactions are possible as indicated in Section 4.8. Rarely symptoms indicating shifts of fluid/electrolytes e.g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing macrogol. If this occurs MOVICOL Paediatric Plain should be stopped immediately, electrolytes measured, and any abnormality should be treated appropriately.

When used in high doses to treat faecal impaction this medicinal product should be administered with caution to patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness.

MOVICOL solution when reconstituted has no calorific value.

4.5  Interactions with other medicinal products and other forms of interaction- Change from Medication Medicinal products
4.7.  Effects on ability to drive and use mechines-There is no effect on the MOVICOL Paediatric Plain has no influence on the
4.8  Undesirable effects-

Abdominal distension and pain, borborygmi and nausea can occur. Diarrhoea or loose stools usually respond to reduction in dose.  In children who are being treated for faecal impaction, mild vomiting is very common (approximately 20%) and this may be resolved if the subsequent dose is reduced or delayed. Other reported undesirable effects include perianal inflammation and soreness. Allergic reactions are a possibility.

The frequency of the adverse reactions listed below is defined using the following convention: very common ( >1/10); common ( >1/100, <1/10); uncommon ( >1/1,000, <1/100); rare ( >1/10,000, <1/1,000); and very rare ( <1/10,000).

 

Chronic Constipation Indication:

Gastrointestinal disorders:

Very common: abdominal pain, borborygmi, diarrhoea or loose stools which normally respond to a reduction in dose.

Common: nausea, mild vomiting, abdominal distension, flatulence, perianal inflammation and soreness.

Immune system disorders:

Rare: allergic reactions

 

Faecal Impaction Indication:

Gastrointestinal disorders:

Very common: mild vomiting, abdominal distension and pain which are attributable to the expansion of the contents of the intestinal tract, perianal inflammation and soreness.

Vomiting may be resolved if the dose is reduced or delayed.

Common: borborygmi, nausea and mild diarrhoea.

Immune system disorders:

Rare: allergic reactions.

5.1  Pharmacodynamic properties-In an open study of MOVICOL (Paediatric Plain) in chronic constipation, weekly defaecation frequency was increased from 1.3 at baseline to 7.7 6.7, 7.2 and 7.1 at weeks 2, 4 and 12 respectively. In a study comparing MOVICOL (Paediatric Plain)
6.3  Shelflife-
6.4  Special precautions for use.

The shelf life of the sachets is 3 years. 

Discard any solution not used within 24 hours.

Reconstituted solution: 24 hours

6.5  Nature and contents of container-6.9g sachets contained in Pack sizes:
6.6 Instruction for use, handling and disposal-

None. Any unused solution should be discarded within 24 hours.

10 Date of revison of the text-           from 30 March 2005 to - Date aapproved 21 July 2006

Updated on 29-Sep-2005 and displayed until 31-Jul-2006

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 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text

Updated on 05-May-2005 and displayed until 29-Sep-2005

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 05-May-2005 and displayed until 05-May-2005

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 05-May-2005 and displayed until 05-May-2005

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 04-May-2005 and displayed until 05-May-2005

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 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text

Updated on 04-May-2005 and displayed until 04-May-2005

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 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text

Updated on 21-Oct-2004 and displayed until 04-May-2005

Reasons for adding or updating:

  • Change to section 1 - trade name
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text

Updated on 15-Mar-2004 and displayed until 21-Oct-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

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Active ingredients

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

Legal categories

POM - Prescription Only Medicine

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