MOVICOL PAEDIATRIC PLAIN 6.9g sachet, powder for oral solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/10/19

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Summary of Product Characteristics last updated on medicines.ie: 4/10/2019

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Norgine Limited

Norgine Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Dantrium Capsules 100mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Capsules 25mg Active Ingredients Dantrolene Sodium
Medicine Name Dantrium Intravenous 20 mg Powder for Solution for Injection Active Ingredients Dantrolene Sodium
Medicine Name MOVICOL 13.8g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Medicine Name Movicol Liquid Orange Flavour Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVICOL PAEDIATRIC PLAIN 6.9g sachet, powder for oral solution Active Ingredients Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
Medicine Name MOVIPREP Orange, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name MOVIPREP, powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name NORMACOL Granules Active Ingredients Sterculia
Medicine Name NORMACOL PLUS Granules Active Ingredients Frangula, Sterculia
Medicine Name Plenvu powder for oral solution Active Ingredients Ascorbic acid, Macrogol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, Sodium sulfate anhydrous
Medicine Name TARGAXAN 550mg film-coated tablets Active Ingredients Rifaximin
1 - 0 of 12 items.Total: Infinity pages

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 10 October 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 4 October 2019 SmPC

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 4 October 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 23 May 2019 PIL

Reasons for updating

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

Updated on 21 January 2019 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 February 2017 PIL

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 PIL

Reasons for updating

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

Updated on 18 January 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 18 January 2016 SmPC

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 20 May 2015 SmPC

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 PIL

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 5 July 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 June 2013 SmPC

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 PIL

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 26 November 2012 SmPC

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 SmPC

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 9 December 2010 PIL

Reasons for updating

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

Updated on 7 July 2008 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 4 December 2006 SmPC

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 2 August 2006 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 July 2006 SmPC

Reasons for updating

  • New SPC for new product

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