Summary of Product Characteristics
last updated on the eMC:
09/06/2008
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 09/06/2008 and displayed until Current
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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 6. 5 - Nature and Contents of Container
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 23-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Underlined text has been added, text with strike through deleted:
List of excipients
Content
Butylated hydroxyanisole
Butylated hydroxytoluene
Triglycerides, mMedium -chain triglycerides
Shell
Gelatin
Glycerol
Karion 83 (Sorbitol, Mannitol, Hydrogenated hydrolysed starch)
Titanium dioxide E171
Canthaxanthin E161Iron oxide red E172
Iron oxide yellow E172
Special precautions for storage
Glass bottles
Do not store above 30°C.
Blisters
Do not store above 25°C. Store in the original containerpackage and keep the blisters in the outer carton in order to protect from light and moisture.
Nature and contents of container
Amber glass bottles with plastic screw caps containing 100 capsules and PVC opaque blisters containing 100 capsules (5 strips of 20 capsules).
Due to the use of a natural colouring agent, discolouration of the capsule may occur. This does not affect the quality of the medicine.
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Updated on 12/06/2007 and displayed until 09/06/2008
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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 revision of the text
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Underlined text has been added:
6.1 List of excipients
Karion 83 (Sorbitol, Mannitol, Hydrogenated hydrolysed starch)
10. DATE OF REVISION OF THE TEXT
Updated to: June 2007
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Updated on 17/01/2006 and displayed until 12/06/2007
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Change to section 7 - Marketing Authorisation Holder
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Addition of Legal Category
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Updated on 16/09/2004 and displayed until 17/01/2006
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Reasons for adding or updating:
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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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Updated on 05/02/2003 and displayed until 16/09/2004
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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 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 06/09/1999 and displayed until 05/02/2003
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Reasons for adding or updating:
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