Summary of Product Characteristics
last updated on the eMC:
22/01/2007
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 22/01/2007 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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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| Date of revision of text on the SPC: 10/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4: Section on abuse added.
Section 4.5: Added interactions with drugs with anticholinergic properties, cholinergic drugs, neuroleptics, erduction in saliva may reduce absorption of sublingual or bucal nitrate tablets, levodopa, cisapride, domperidone, metoclopramide, quinidine, ketoconazole, high environamental temperature, paroxetine.
Section 4.8: Added impaired cognition and memory, disorientation, anxiety and agitation at high doses. Psychotic-symptoms have been reported rarely.
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Updated on 28/08/2002 and displayed until 22/01/2007
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 31/07/2002 and displayed until 28/08/2002
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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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Updated on 14/12/2001 and displayed until 31/07/2002
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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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