Summary of Product Characteristics
last updated on the eMC:
20/04/2009
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 20/04/2009 and displayed until Current
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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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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 14-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 - Addition of drugs which may interact with nifedipine: macrolide antibiotics, gingko biloba, ginseng and St John's Wort.
Section 4.8 - Addition of mood changes, ischaemic pain, myasthenia gravis
Section 4.9 - Management of overdose added
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Updated on 15/09/2005 and displayed until 20/04/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/09/2004 and displayed until 15/09/2005
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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