6.5      Nature and contents of container

This product is available in rectangular sachets and tubular (stick-pack) sachets.

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

Pack sizes: boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Not all sachets and pack sizes may be marketed.

10       DATE OF REVISION OF THE TEXT

           06 April 2023

6.Contents of the pack and other information

What Movicol Paediatric Plain looks like and contents of the pack

Movicol Paediatric Plain is available in rectangular sachets and tubular (stick-pack) sachets.

Movicol Paediatric Plain is a white powder.

Movicol Paediatric Plain is available in boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Not all sachets and pack sizes may be marketed.

This leaflet was last revised in 034/2023

4.5       Interaction with other medicinal products and other forms of interaction

There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics. Therefore, other medicines should not be taken orally for one hour before, during and for one hour after taking Movicol Paediatric Plain.

5.3       Preclinical safety data

Indirect embryofoetal effects, including reduction in foetal and placental weights, reduced foetal 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.

10.      DATE OF REVISION OF THE TEXT

28 March 2023

Movicol^® Paediatric Plain 6.9g sachet, powder for oral solution

(Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride)

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

Other medicines and 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), other medicines may be flushed through your digestive system. yYour child should not take any other medicines by mouth together with Movicol Paediatric Plain and for one hour before and for one hour after within one hour of taking Movicol Paediatric Plain.

5.        How to store Movicol Paediatric Plain

Do not use Movicol Paediatric Plain after the expiry date which is stated on the sachet and carton. 

The expiry date refers to the last day of that month.

6.        Contents of the pack and other information

IE and MT Marketing Authorisation Holder:

The medicinal product medicine is authorised in the Member States of the EEA European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

United Kingdom          MOVICOL Paediatric Plain                                                                                                                

(Northern Ireland)

This leaflet was last revised in 03/20223

6.         Contents of the pack and other information

Manufacturer:

Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, United Kingdom.

Or

Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands.

Or

Recipharm Höganäs AB, Sporthallsvägen 6, Höganäs, 263 3534, Sweden.

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

Austria                                     MOVICOL Junior aromafrei

Belgium                                   MOVICOL Junior Neutral

Denmark                                 MOVICOL Junior Neutral

Finland                                    MOVICOL Junior Plain

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

Iceland                                    MOVICOL Junior Neutral

Ireland                                     MOVICOL Paediatric Plain

Italy                                         MOVICOL Bambini 6,9 g polvere per soluzione orale Senza Aroma

Luxembourg                            MOVICOL Junior Neutral

Malta                                       MOVICOL Paediatric Plain

Netherlands                            Movicolon Junior Naturel

Norway                                    MOVICOL Junior

Portugal                                  MOVICOL Pediátrico Sabor Neutro

Spain                                       MOVICOL Pediátrico Sabor Neutro

Sweden                                   Movicol Junior Neutral

UK                                           MOVICOL Paediatric Plain

This leaflet was last revised in 04/2021 02/2022

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

2. 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.

6. 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

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

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.

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:

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

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

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 1^st two Classes:

10        DATE OF REVISION OF THE TEXT

January 2016

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

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’

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