Summary of Product Characteristics
last updated on the eMC:
08/01/2010
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 08/01/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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: 29-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 'Contraindications'
Section 10 - Date of revision
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Updated on 02/11/2009 and displayed until 08/01/2010
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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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| Date of revision of text on the SPC: 25-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 'Special warnings and precautions for use' of the SPCs have been updated in line with the guidance documents, issued by the MHRA, on minimum clinical particulars, for non-selective non-steroidal anti-inflammatory drugs for systemic administration.
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Updated on 23/07/2009 and displayed until 02/11/2009
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 17-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The changes are to Sections 6.3, 6.4 and 6.5. - To include an additional packaging material with a shelf life of 60 months
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Updated on 01/09/2008 and displayed until 23/07/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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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| Date of revision of text on the SPC: 22-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- In section 4.3 (Contraindications) the following wording has been added 'Diclomax should not be used concomitantly with other NSAIDs including the cyclo-oxygenase-2-specific inhibitors (see section 4.5)
- In section 4.5 (Interactions with other medicinal products and other forms of interaction the following has been added 'Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of GI bleeding (see section 4.4) and Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
- In section 4.8 (Undesirable effects) the following has been added 'Pancreatitis has been reported very rarely' and under 'Cardiovascular and cerebrovascular' the following has been added 'hypertension and cardiac failure have been reported in association with NSAID treatment'.
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Updated on 24/06/2008 and displayed until 01/09/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 05-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 7. (Marketing Authorisation Holder), the name has been changed from KoGEN to Galen Limited.
In section 10. the date of revision has been changed to 05 June 2008.
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Updated on 10/06/2008 and displayed until 24/06/2008
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 10-Jun-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 9: Date changed to 09 March 1993
Section 10: Date changed to 10 June 2007
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Updated on 10/07/2007 and displayed until 10/06/2008
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Reasons for adding or updating:
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Change to separate SPCs covering individual presentations
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition of separate SPC covering individual presentation
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Updated on 01/05/2007 and displayed until 10/07/2007
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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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Pending awaiting re-submission
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to cardiovasular warnings
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Updated on 12/08/2005 and displayed until 01/05/2007
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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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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Change from BAN to rINN
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Updated on 01/09/2003 and displayed until 12/08/2005
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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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Updated on 05/09/2002 and displayed until 01/09/2003
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Reasons for adding or updating:
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New SPC for new product
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Change to section 7 - Marketing Authorisation Holder
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Addition of joint SPC covering all presentations
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