Summary of Product Characteristics
last updated on the eMC:
28/10/2008
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 28/10/2008 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 4.6 - 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 6.2 - Incompatibilities
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 01-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3
Furhter clarification of first sentence
Section 4.4
Change from 'administration of paracetamol' to 'administration of product'
Add 'sight' to KOOROC warning
Section 4.5
Interactions with bromocriptine and isometheptine and an increased risk of a hypertensive crisis when sympathomimetics are given with MAOIs, added
Section 4.6
Addition of avoid in lactation
Section 4.8
Totally updated
Section 4.9
Totally updated
Section 5.2
Correction of 'accounts' to 'amounts' in 3rd para
Section 6.2
updated to 'not applicable'
Section 6.4
Terminology updated
Section 9
Renewal date added
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Updated on 26/09/2008 and displayed until 28/10/2008
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 11-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Updated MA holder address:
Taylor Group House
Wedgnock Lane
Warwick
CV34 5YA
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Updated on 29/09/2006 and displayed until 26/09/2008
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Reasons for adding or updating:
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