Summary of Product Characteristics
last updated on the eMC:
29/11/2006
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 29/11/2006 and displayed until Current
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Reasons for adding or updating:
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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 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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| Added text is shown in red
Section 4.4 Special Warnings and Precautions for Use
The following text has been added: Regular ongoing monitoring and blood tests are to be performed in elderly patients and patients who are on long term treatment with bendroflumethiazide.
Section 4.5 Interactions with other Medicaments and other forms of Interaction
The following text has been added: Xanthines, beta-agonists, ACTH, corticosteroids, acetazolamide and carbenoxolone may exacerbate the hypokalaemia associated with thiazide use. Thiazide diuretics may enhance the neuromuscular blocking effects of the non-depolarising muscle relaxants, e.g. tubocurarine.
Section 10 Date of (Partial) Revision of the Text
06 october 2006
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Updated on 27/09/2005 and displayed until 29/11/2006
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Reasons for adding or updating:
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Updated on 25/09/2003 and displayed until 27/09/2005
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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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