Summary of Product Characteristics
last updated on the eMC:
07/09/2011
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 07/09/2011 and displayed until Current
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Reasons for adding or updating:
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 11-Aug-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 Interactions- has been updated regarding possible food interactions.
Section 10 Date of Revision of the Text- updated to 11 August 2011.
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Updated on 23/03/2009 and displayed until 07/09/2011
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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SPC Retired pending re-submission
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| Date of revision of text on the SPC: 12-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7.
Amend address:
Laboratoire Innotech International
22 avenue Aristide Briand
94110 Arcueil
France
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Updated on 16/01/2009 and displayed until 23/03/2009
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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 6.1 - List of Excipients
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| Date of revision of text on the SPC: 08-Jan-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Additional text added to each section
2. Qualitative and Quantitative Composition
For a full list of excipients, see section 6.1
4.3 Contra-indications
This product contains partially hydrogenated soybean oil. Patients should not take this medicinal product if they are allergic to peanut or soya.
4.4 Special Warnings and Precautions for Use
This product contains sorbitol (E420) and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The sucrose in this product may be harmful to teeth if taken chronically, e.g. for two weeks or more.
4.8 Undesirable Effects
This product contains sucrose. May be harmful to teeth if taken chronically, e.g. for two weeks or more.
6.1 List of Excipients
Sorbitol (E420)
Povidone
The colecalciferol is present as a concentrate powder that also contains:
DL-alpha-Tocopherol
Partially hydrogenated soybean oil
Gelatin
Sucrose
Corn starch
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Updated on 04/09/2007 and displayed until 16/01/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 07/2004 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7. Marketing Authorisation Holder
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Updated on 07/11/2001 and displayed until 04/09/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 21/08/2001 and displayed until 07/11/2001
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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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Updated on 21/08/2001 and displayed until 21/08/2001
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Updated on 06/09/1999 and displayed until 21/08/2001
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