Summary of Product Characteristics
last updated on the eMC:
07/09/2009
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 07/09/2009 and displayed until Current
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Reasons for adding or updating:
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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: 03-Aug-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 of the SPC has been updated, please text below:
Gastrointestinal disorders: Gastrointestinal obstruction or impaction
Immune system disorders SOC: Allergy or Hypersensitivity (have been reported with hydrophilic mucilloid preparations).
Gastrointestinal disorders: Regulan (Ispaghula), as with other bulk laxatives, may temporarily increase flatulence and abdominal distension when the product is first used. Other symptoms including nausea, diarrhoea and abdominal discomfort or pain have rarely been reported (<1 in 1000).
Intestinal obstruction and faecal impaction may occur very rarely (<1 in 10,000), especially if the product is taken with insufficient fluid.
Immune system disorders SOC: There are very rare reports (<1 in 10,000) of allergic or hypersensitivity reactions associated with the ingestion or inhalation of Ispaghula including skin rashes or allergic dermatitis, rhinitis, urticaria, bronchospasm and anaphylactic reactions.
Section 10 of the SPC has been updated, please text below:
January 2006
June 2009
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Updated on 25/10/2006 and displayed until 07/09/2009
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Reasons for adding or updating:
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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: 01/2006 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Licence renewal, minor changes to text.
Addition of the following to Section 4.8:
Immune system disorders SOC: Allergy or Hypersensitivity (have been reported with hydrophilic mucilloid preparations).
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Updated on 09/08/2004 and displayed until 25/10/2006
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Change to section 5.3 - Preclinical Safety Data
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Updated on 25/07/2001 and displayed until 09/08/2004
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Updated on 24/11/2000 and displayed until 25/07/2001
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