Summary of Product Characteristics
last updated on the eMC:
04/12/2008
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 04/12/2008 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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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 01-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4 additional paragraph has been added:
In-vitro data have demonstrated that the release rate of oxycodone from the OxyContin formulation is maintained in varying concentrations of ethanol. Therefore, patients already established on an alcohol-resistant prolonged release formulation of oxycodone should not be switched to an alternative alcohol-susceptible formulation of oxycodone. As with all opioids, concomitant administration of alcohol is not recommended due to the increased CNS depressant effects (see also section 4.5 and 5.3).
Section 5.3 additional paragraph has been added:
In vitro dissolution data generated using the standard dissolution method, show that in the presence of ethanol, at concentrations up to 40%, the prolonged release characteristics of the OxyContin formulation were maintained and no breakdown of the prolonged release mechanism was observed.
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Updated on 30/10/2008 and displayed until 04/12/2008
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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: 01-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Sections 4.4 and 4.8 have been re-written
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Updated on 05/06/2007 and displayed until 30/10/2008
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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5.1 Pharmacodynamic Properties:
Clinical studies (paragraph has been changed to read:)
The efficacy of OxyContin tablets has been demonstrated in cancer pain, post-operative pain and severe non-malignant pain such as diabetic neuropathy, postherpetic neuralgia, low back pain and osteoarthritis. In the latter indication, treatment was continued for up to 18 months and proved effective in many patients for whom NSAIDs alone provided inadequate relief. The efficacy of OxyContin tablets in neuropathic pain was confirmed by three placebo-controlled studies.
In patients with chronic non-malignant pain, maintenance of analgesia with stable dosing was demonstrated for up to three years.
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Updated on 07/12/2006 and displayed until 05/06/2007
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 03/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of the black triangle
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Updated on 15/07/2005 and displayed until 07/12/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.2 - Incompatibilities
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 21/05/2004 and displayed until 15/07/2005
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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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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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 6.1 - List of Excipients
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Change to section 10 (date of (partial) revision of the text
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Addition of Black Triangle
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Updated on 12/05/2003 and displayed until 21/05/2004
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Reasons for adding or updating:
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Removal of Black Triangle
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Updated on 25/09/2002 and displayed until 12/05/2003
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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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Correction of spelling/typing errors
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Updated on 10/06/2002 and displayed until 25/09/2002
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Reasons for adding or updating:
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Updated on 01/02/2002 and displayed until 10/06/2002
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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 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/08/2001 and displayed until 01/02/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 24/03/2000 and displayed until 28/08/2001
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Reasons for adding or updating:
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