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Norgine Limited

Norgine Limited
Chaplin House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS , UK
Telephone: +44 (0)1895 826 600
Fax: +44 (0)1895 825 865
Summary of Product Characteristics last updated on medicines.ie: 13/12/2010
SPC MOVICOL PAEDIATRIC PLAIN 6.9g sachet, powder for oral solution

When a pharmaceutical company changes an SPC or PIL, 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 13/12/2010 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   09-Sep-2010
Legal Category:   Supply through pharmacy only

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 07/07/2008 and displayed until 13/12/2010
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 04/12/2006 and displayed until 07/07/2008
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:   11/2006
Legal Category:   prescription only

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 31/07/2006 and displayed until 04/12/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Potassium Chloride
   Sodium Chloride
   Sodium Hydrogen Carbonate
   Macrogol 3350

Versions

 
13/12/2010 to Current
07/07/2008 to 13/12/2010
04/12/2006 to 07/07/2008
31/07/2006 to 04/12/2006
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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