Summary of Product Characteristics
last updated on the eMC:
28/02/2011
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 28/02/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 23-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8: Within subsection 'cardiac disorders'; prolonged QT Interval (particularly in patient with impaired renal function) has been added to the list of adverse reactions.
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Updated on 20/01/2010 and displayed until 28/02/2011
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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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| Date of revision of text on the SPC: 12-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4: Information on the use in children, elderly, and ulcer disease have been added.
Sections 4.5 and 4.7: These sections have been editorially changed.
These sections have been editorially changed.
Section 4.8: This section has been re-organised and a small number of side effects have been added including hepatitis and alopecia.
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Updated on 14/05/2009 and displayed until 20/01/2010
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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: 01-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Reduction in the shelf-life of the tablets from 36 to 24 months.
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Updated on 01/07/2008 and displayed until 14/05/2009
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.9 - Overdose
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - Text under 'Use in impaired renal function' has been revised for reduced dosing in patients with renal insufficiency.
Section 4.5
- Additional interactions have been added under subheadings: Probenecid; Antacids; Ketoconazole/Itraconazole
Section 4.8
- This section has been updated to MeDRA requirements, plus additional side effects added for: 'impotence, reduced libido, parathesia, epileptic seizures/convulsions in patients with impaired renal function, and insomnia'.
Section 4.9 - The text has updated based on cumulative reports and current knowledge.
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Updated on 18/08/2003 and displayed until 01/07/2008
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 04/03/2002 and displayed until 18/08/2003
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 05/11/2001 and displayed until 04/03/2002
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Updated on 16/08/2001 and displayed until 05/11/2001
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Transferred from eMC version 1
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Updated on 26/03/2001 and displayed until 16/08/2001
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Updated on 02/06/2000 and displayed until 26/03/2001
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Updated on 06/09/1999 and displayed until 02/06/2000
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