Summary of Product Characteristics
last updated on the eMC:
28/05/2010
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 28/05/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 24-May-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - addition of dosage restrictions for elderly patients
Section 4.4 - addition of warning to avoid use with other antihistamines, and warning re: fructose intolerance etc.
Section 4.5 - addition of recommendation to seek medical advice before taking chlorphenamine concurrently with hypnotics or anxiolytics
Section 4.6 - advice revised to not use during pregnancy and lactation unless considered essential by a physician
Section 4.8 - section reformatted and information on frequency of events added
Section 4.9 - removal of advice to use gastric lavage and induced emesis to treat overdose, and that treatment should be given within an hour of ingestion
Section 5.1 - addition of ATC code and revision of pharmacodynamic effects
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Updated on 29/11/2007 and displayed until 28/05/2010
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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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: 11/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.5 - Addition of pack size of 60
Section 10 - updated to November 2007
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Updated on 19/05/2005 and displayed until 29/11/2007
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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