Summary of Product Characteristics
last updated on the eMC:
05/12/2011
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 05/12/2011 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: 22-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Patients and their carers must be instructed that Effentora contains an active substance in an amount that can be fatal, especially to a child. and tTherefore they must to keep all tablets out of the reach and sight of children.
As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl. Improper patient selection (e.g., use in patients without maintenance opioid therapy) and/or improper dosing have resulted in fatal outcome with Effentora as well as with other fentanyl products.
Effentora should only be used for conditions specified in section 4.1.
Also, addition of the headings for Chronic obstructive pulmonary disease, Increased intracranial pressure, impaired consciousness, Cardiac disease, Hepatic or renal impairment, Tolerance, dependence and Controlled sodium diet.
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Updated on 05/02/2010 and displayed until 05/12/2011
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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: 25-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 6.3 has been updated to change the shelf life from 2 years to 3 years
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Updated on 05/01/2010 and displayed until 05/02/2010
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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 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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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 5.2 - Pharmacokinetic 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: 10-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| sections 4.2, 4.3, 4.4, 4.6, 4.8, 4.9, 5.2 and 5.3 to include sub-lingual use, contraindicate acute pain, amend the breastfeeding information, updated the adverse event information, update the overdose information and update the pre-clinical safety data.
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Updated on 16/01/2009 and displayed until 05/01/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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