Summary of Product Characteristics
last updated on the eMC:
13/08/2007
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 13/08/2007 and displayed until Current
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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 4.5 - 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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| Date of revision of text on the SPC: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 Posology and method of administration – statement added: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). 4.3 Contra-indications - additional statement regarding gastro-intestinal contra-indications.
4.4 Special warnings and precautions - additional statement regarding lowest effective dose. Additional warnings regarding gastro-intestinal effects, the elderly, concomitant medication, serious skin reactions, cardiovascular and cerebrovascular effects.
4.5 Interactions - statement on corticosteroids, anti-platelet agents and SSRIs added.
4.6 Pregnancy and lactation - pregnancy statement updated.
4.8 Undesirable effects - statements added on gastrointestinal effects, bullous reactions, cardiovascular and cerebrovascular effects.
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Updated on 23/11/2005 and displayed until 13/08/2007
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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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