Summary of Product Characteristics
last updated on the eMC:
27/01/2009
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 27/01/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jan-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.5 Interaction with other Medicinal Products and other forms of Interaction
…..absorbed.
Clinical interactions with other drugs have been reported extremely rarely. No specific reactions with individual drugs or classes of drugs have been observed.
Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. There is therefore a theoretical possibility that the absorption of such medicinal products could be transiently reduced.
4.8. Undesirable Effects
Reactions related to the gastrointestinal tract are the most common to occur. These may include:
Abdominal pain
Nausea
Borborygmi
Diarrhoea
Abdominal distension
Vomiting
Flatulence
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-Half. Mild diarrhoea usually responds to dose reduction.
Allergic reactions, including anaphylaxis. Other symptoms of allergic reactions include pruritus, urticaria and dyspnoea.
10. Date of (Partial) Revision of the Text
Approved: January 2009
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Updated on 01/11/2007 and displayed until 27/01/2009
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 5.1
Deletion of:
The electrolytes also present in the formulation also ensure that there is virtually no net gain or loss of sodium, potassium or water. The lacative action of macrogol 3350 has a time course which will vary according to the severity of the consitpation or faecal impaction being treated.
And replaced with:
Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The phyisological 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
Deletion of:
'and has no known pharmacological activity.'
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Updated on 07/09/2004 and displayed until 01/11/2007
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 3 - Shelf Life
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Change to section 10 (date of (partial) revision of the text
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Updated on 04/09/2003 and displayed until 07/09/2004
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Reasons for adding or updating:
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