Summary of Product Characteristics
last updated on the eMC:
02/09/2010
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 02/09/2010 and displayed until Current
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Reasons for adding or updating:
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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 4.5 - 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: 01-May-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3 – Contra-indications to concomitant use of other sympathomimetic decongestants, phaeochromosytoma and closed angle glaucoma added.
Section 4.4 – Special warnings and precautions added for enlarged prostate gland, occlusive vascular disease and cardiovascular disease. Warning to avoid excessive intake of caffeine added.
Section 4.5 – Addition of table detailing nature of drug interactions.
Section 4.8 – Addition of table listing undesirable effects by ingredient and body system.
Section 4.9 – Revision of treatment advice relating to caffeine, and addition of section relating to phenylephrine.
Section 10 - New revision date
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Updated on 23/06/2009 and displayed until 02/09/2010
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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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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