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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Change to section 10 date of revision of the text
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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 included on abuse
Section 4.5: Addition of interactions with: drugs with anticholinergic properties, cholinergic properties, reduced absorption of buccal or sublingual nitrate tablets due to reduced salivation, levodopa, cisapirde, metoclopramide, domperidone, quinidine, ketoconazole, high environmental temperature, paroxetine
Section 4.8: Addition of impaired cognition and memeory, disorientation, anxiety, and agitation at high doses. Rarely psychotic-like symotioms have been reported.
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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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Change to section 1 - trade name
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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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Change to section 7 - Marketing Authorisation Holder
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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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