Summary of Product Characteristics
last updated on the eMC:
15/08/2011
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 15/08/2011 and displayed until Current
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Reasons for adding or updating:
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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: 24-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Date of revision 24 September 2010
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Updated on 28/05/2009 and displayed until 15/08/2011
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Reasons for adding or updating:
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Introduction of new pack/pack size
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| Date of revision of text on the SPC: 21-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Introdcution of a 30 capsule pack
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Updated on 27/10/2008 and displayed until 28/05/2009
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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: 13-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - Skin and subcutaneous tissues disorders - cross-reference to section 4.5 added.
Section 4.5 - avoidance of concurrent administration with topical keratolytic or exfoliative anti-acne agents advised. Cross-reference to section 4.4. Additional text
Section 4.7 - additional warnings added in second paragrpah.
Section 4.8 - additional undesirable effects in Psychiatric disorders, Nervous system disorders and Eye disorders
Section 10 - date of revision of text updated to 13 October 2008
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Updated on 06/12/2006 and displayed until 27/10/2008
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3 (Contraindication) - patients with peanut allergy may suffer cross reactivity to soya protein added
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Updated on 28/11/2006 and displayed until 06/12/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3 (Contraindications) - patients with peanut allergy may suffer cross reactivity to soya protein added
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Updated on 08/11/2006 and displayed until 28/11/2006
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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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| Date of revision of text on the SPC: 02/2006 |
| 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) under Psychiatric disorders - added 'suicidal ideation, suicide attempts'
Section 4.8 - (Undesirable effects) under Psychiatric disorders - Very Rare - added 'suicidal ideation, suicide attempt'
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Updated on 13/06/2005 and displayed until 08/11/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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SPC Retired pending re-submission
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Updated on 13/06/2005 and displayed until 13/06/2005
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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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Updated on 11/01/2005 and displayed until 13/06/2005
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Reasons for adding or updating:
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