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Norgine Limited
Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS
Telephone: +44 (0)1895 826 600
Fax: +44 (0)1895 825 865
E-mail:
Medical Information e-mail: medinfo@norgine.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 22/11/2011
SPC MOVICOL Plain 13.7g sachet, powder for oral solution

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 22/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-May-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 9; 'Date of last renewal: 25 January 2011' - has been added.
Updated on 07/06/2011 and displayed until 22/11/2011
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:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updated inline with current safety information.
Updated on 08/12/2010 and displayed until 07/06/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   09-Sep-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 updated to include statement with respect to reduced efficacy eith concomitantly administered medicinal products e.g. anti-epileptics.

Section 4.8 updated with tabulated results of the adverse events.
Updated on 16/03/2010 and displayed until 08/12/2010
Reasons for adding or 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 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-May-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SPC - Changes to Sections 4.4, 4.5 & 4.8. 

Updated on 19/01/2009 and displayed until 16/03/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • 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 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Nov-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


2.

following active ingredients:

Macrogol (Polyethylene Glycol) 3350

13.1250 g

4.1        ectum and/or colon. confirmed by physical examination of the abdomen and rectum.

4.2       Posology and method of administration

Children (below 12 years old): Not recommended. Alternative MOVICOL products are available for children.

Children (below 12 years old): Not recommended. Alternative MOVICOL products are available for children.

4.3       Contraindications

Known hHypersensitivity to any of the active substancesingredients or to any of the excipients.

4.4       Special warnings and precautions for use

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

4.5       Interaction with other medicinal products and other forms of interaction

Macrogol raises the solubility of drugs medicinal products that are soluble in alcohol and relatively insoluble in water.  There is therefore a theoretical possibility that the absorption of such drugs medicinal products could be transiently reduced.

4.7       Effects on ability to drive and use machines

There MOVICOL Plain has no influence is no effect on the ability to drive and use machines.

5.1       Pharmacodynamic properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

6.3       Shelf life

The shelf life of the sachets is 3 years. 

Reconstituted solution: Discard any solution not used within 6 hours.

6.4       Special precautions for storage

Sachet:  Do not store above 25°C.

Reconstituted sSolution: Store at 2-8ºC (in a refrigerator and covered)

6.5       Nature and contents of container

Each sachet contains 13.7 g of powder.

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

13.7g sachets contained inPack sizes:  .

6.6       Special precautions for disposal

None.Any unused solution should be discarded within 6 hours

10      DATE OF REVISION OF THE TEXT

09 March 20075 Nov 2008
Updated on 13/08/2007 and displayed until 19/01/2009
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:   03/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

5.1    Pharmacodynamic properties

ATC code: A06A D65

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 constipation or 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.

5.2    Pharmacokinetic properties

Macrogol 3350 is unchanged along the gut.  It is virtually unabsorbed from the gastro-intestinal tract and has no known pharmacological activity.  Any macrogol 3350 that is absorbed is excreted via the urine.

 

10      DATE OF REVISION OF THE TEXT

09 March 2007
Updated on 22/02/2007 and displayed until 13/08/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  potassium chloride
  sodium chloride
  sodium hydrogen carbonate
  macrogol 3350