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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

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Summary of Product Characteristics last updated on the eMC: 07/06/2011
SPC Movicol 13.8g 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 07/06/2011 and displayed until Current
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 01/12/2010 and displayed until 07/06/2011
Reasons for adding or updating:
  • 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
Adverse events tabulated.
Updated on 16/03/2010 and displayed until 01/12/2010
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

MOVICOL SPC - Changes to Sections 4.4, 4.5 & 4.8. 

Addition of, of to section 4.4.

The absorption of other medicinal products could transiently be reduced due to an increase in gastro-intestinal transit rate induced by MOVICOL (see section 4.5).

Addition of, of to section 4.5

There is a possibility that the absorption of other medicinal products could be transiently reduced during use with MOVICOL (see section 4.4).There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics.

Change to section 4.8

Immune System Disorders

 

Allergic reactions, including anaphylactic reaction. Other symptoms of allergic reactions include dyspnoea, urticaria and pruritus.

 

Gastrointestinal Disorders

 

Abdominal pain

Abdominal distension

Vomiting

Diarrhoea

Nausea

Flatulence

Borborygmi

Anal discomfort

 

These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of MOVICOL. Mild diarrhoea which usually responds to dose reduction.

 

 
Updated on 16/08/2007 and displayed until 16/03/2010
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 17/04/2007 and displayed until 16/08/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • 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 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:   03/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

2.      Macrogol 3350 (Polyethylene Glycol 3350)       13.125 g

 

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

4.2    Children below 12 years old: Not recommended. Alternative  Movicol products are available for children.

4.3    Known hypersensitivity to any of these active substances or to any of the excipients. Hypersensitivity to the active ingredients 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.

         There is no clinical trial data on the use of Movicol in children, therefore it is not recommended.

4.5    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    There is no effect Movicol has no influence on the ability to drive and use machines.

 

5.1    Pharmacotherapeutic group: Osmotically acting laxatives.

6.1    List of Excipients

         Acesulfame K potassium (E950)

         Lime and lemon flavour*

         (Lime and lemon flavour contains the following constituents: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water).

6.3    Shelf life

         The shelf life of the sachets is 3 years.

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

6.4    Reconstituted solution: Store at 2 - 8°C (in a refrigerator and covered).

6.5    Nature and contents of container

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

         13.8g sachets contained in Pack sizes: boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.  Not all pack sizes may be marketed.

6.6    Special precautions for disposal

         None. Any unused solution should be discarded within 6 hours.

9       Date of the first authorisation or renewal

         18th December 1995 / March 2001 18th December 2005

10     Date of revision of the text

         August 2002 August 2005 August 2006 March 2007
Updated on 01/12/2006 and displayed until 17/04/2007
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:   09/2006
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.  . .  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:

gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

 Section 10: 12 September 2006

Updated on 08/09/2003 and displayed until 01/12/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 13/12/2002 and displayed until 08/09/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 10/04/2002 and displayed until 13/12/2002
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 08/04/2002 and displayed until 10/04/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 13/08/2001 and displayed until 08/04/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 13/08/2001 and displayed until 13/08/2001
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 13/08/2001 and displayed until 13/08/2001
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 06/09/1999 and displayed until 13/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  potassium chloride
  sodium chloride
  sodium bicarbonate
  macrogol 3350