Summary of Product Characteristics
last updated on the eMC:
04/01/2012
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 04/01/2012 and displayed until Current
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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 - Contraindications
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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 4.9 - Overdose
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| Date of revision of text on the SPC: 30-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The SPC has been updated with information in line with the recommendations of a Paediatric Assessment Report for Metoclopramide following a European work-sharing procedure.
Updated sections of the SmPC include Sections 4.1, 4.2, 4.3, 4.4, 4.8 and 4.9.
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Updated on 22/02/2011 and displayed until 04/01/2012
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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: 09-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.3 - the shelf life has been changed from 24 months to 36 months.
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Updated on 14/01/2009 and displayed until 22/02/2011
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Reasons for adding or updating:
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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: 15-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 has been updated to advise that “Metoclopramide may increase the absorption of ciclosporin and raise its blood levels”.
Section 4.8 has been updated to advise that “Transient hypotension followed by compensatory tachycardia may occur”.
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Updated on 09/06/2008 and displayed until 14/01/2009
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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