Summary of Product Characteristics
last updated on the eMC:
11/01/2010
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 11/01/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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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-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
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Free-text change information supplied by the pharmaceutical company
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| In section 4.4 (special warnings and precautions for use) advice in renal impairment and elderly patients has been added.
In section 4.8 (undesirable effects) a comment regarding frequency categories and incidence has been added. Anaphylaxis has been changed to 'rarely' anaphylaxis. The heading for nervous system disorders has been updated to read 'psychiatric and' nervous system disorders. Headache and dizziness have both been added as common effects. Very rare effects of agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy and coma have been added. A heading for respiratory, thoracic and mediastinal disorders has been added, with dyspnoea as a rare effect. The GI symptoms listed have been updated to read commonly reported. Under skin and subcutaneous tissue disorders, pruritis, rashes (including photosensitivity) have been added as common. Uncommon effects have been updated to include urticaria. Occasional reports of hair loss has been added. Angioedema has been added as a rare event. Under renal and urinary disorders, renal pain has been added.
In section 10 (date of revision of the text) the date had been updated to 03-Nov-2009.
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Updated on 28/07/2005 and displayed until 11/01/2010
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 26/07/2005 and displayed until 28/07/2005
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Reasons for adding or updating:
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