Summary of Product Characteristics
last updated on the eMC:
23/05/2012
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 23/05/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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| Date of revision of text on the SPC: 22-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changed From:
4.5 Interaction with other medicinal products and other forms of interaction
No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.
Although an antagonism between Serc and antihistamines could be expected on a theoretical basis, no such interactions have been reported.
Changed To:
4.5 Interaction with other medicinal products and other forms of interaction
No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.
In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoamino-oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly.
As betahistine is an analogue of histamine, interaction of betahistine with antihistamines may in theory affect the efficacy of one of these drugs.
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Updated on 21/05/2012 and displayed until 23/05/2012
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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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| Date of revision of text on the SPC: 01-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changed From:
4.2 Posology and method of administration
Adults (including the elderly): initially two tablets three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.
Children: No dosage recommendations.
Changed To:
4.2 Posology and method of administration
Adults (including the elderly): initially two tablets three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.
Paediatric population: not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
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Updated on 12/04/2011 and displayed until 21/05/2012
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Company name change or merger
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Change to MA holder contact details
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| Date of revision of text on the SPC: 28-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 7. The Marketing Authorisation Holder has changed name from Solvay Healthcare Limited to Abbott Healthcare Products Ltd
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Updated on 06/08/2009 and displayed until 12/04/2011
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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