Summary of Product Characteristics
last updated on the eMC:
04/06/2008
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 04/06/2008 and displayed until Current
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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: 28-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 - Avoid abrupt withdrawal of treatment - has been added.
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Updated on 19/06/2007 and displayed until 04/06/2008
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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 4.4 - Special warnings and precautions for Use
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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):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.3 - the following sentence was added
Hypersensitivity to orphenadrine, or to any of the excipients.
Section 4.4- the following sentence was added
Contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
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Updated on 07/07/2003 and displayed until 19/06/2007
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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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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 16/01/2003 and displayed until 07/07/2003
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Transferred from eMC version 1
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Updated on 29/04/2002 and displayed until 16/01/2003
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Change to section 4.8 - Undesirable Effects
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Updated on 16/07/2001 and displayed until 29/04/2002
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Correction of spelling/typing errors
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Updated on 12/07/2001 and displayed until 16/07/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 19/02/2001 and displayed until 12/07/2001
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Updated on 06/03/2000 and displayed until 19/02/2001
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Updated on 06/09/1999 and displayed until 06/03/2000
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