Summary of Product Characteristics
last updated on the eMC:
21/12/2011
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 21/12/2011 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 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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 08-Dec-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- To update Section 4.3 by adding a contraindication for concomitant use with ergot-derivatives
- To update Section 4.4 with additional warnings and precautions for use on hepatic toxicity, QT prolongation and Torsades de Pointes. In addition a lactose warning has been added.
- To update Section 4.5 by including additional interactions with antiarrythmic drugs, pharmacodynamic interactions, Carbamazepine, Phenobarbital, Phenytoin, Rifapentin, ergot derivatives, Losartan, Fentanyl, Methadone and Sirolimus.
- To update Section 4.7 of the SPC with the following: "No studies on the effect on the ability to drive and use machines have been performed. However, undesirable effects such as dizziness have been observed. If dizziness occurs, patients should not drive or operate machines."
- To update Section 4.8 of the SPC with additional undesirable effects. The information has also been arranged by MedDRA system organ class.
- To update section 5.3 (Preclinical safety data) of the SPC in line with current medical knowledge and additionally section 5.1 (Pharmacodynamic properties) with the Pharmacotherapeutic group and ATC Code.
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Updated on 28/10/2009 and displayed until 21/12/2011
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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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| Date of revision of text on the SPC: 06-Oct-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 6.1 (list of excipients), change in ink formulation
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Updated on 29/06/2006 and displayed until 28/10/2009
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 12/2005 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Shelf life has changed from 2 to 3 years
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Updated on 06/02/2004 and displayed until 29/06/2006
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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