Summary of Product Characteristics
last updated on the eMC:
22/06/2007
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 22/06/2007 and displayed until Current
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 17/05/2007 and displayed until 22/06/2007
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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 4.3 - Contraindications
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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 1 -Name of the Medicinal product
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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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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Pending awaiting re-submission
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
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Free-text change information supplied by the pharmaceutical company
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4.2 – undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms
4.3 – addition of severe heart failure
4.4 – same statement as above for 4.2, expanded precautions & warnings for patients with CV risk
4.8 – addition of adverse events hypertension & cardiac failure, clinical trial & epidemiological data suggest that some NSAIDs may be associated with a small increased risk of arterial thrombotic events
In addition, reference to Feldene Dispersible tablets has been removed from sections 1-4.2, 5.1, 5.2, 6.1, 6.3-6.5, 8 & 9.
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Updated on 21/07/2003 and displayed until 17/05/2007
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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 5.2 - Pharmacokinetic Properties
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Updated on 20/07/2001 and displayed until 21/07/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/07/2001 and displayed until 20/07/2001
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Updated on 19/07/2001 and displayed until 20/07/2001
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Updated on 04/02/2000 and displayed until 19/07/2001
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Updated on 06/09/1999 and displayed until 04/02/2000
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