Summary of Product Characteristics
last updated on the eMC:
26/01/2012
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 26/01/2012 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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| Date of revision of text on the SPC: 01-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In the previous SmPC for Colomycin Tablets, the dose stated for children up to 15kg weight was “250,000 to 500,000 units every 8 hours”. As each tablet contains 1,500,000 units, this equates to between one sixth and one third of a tablet. No studies have ever been conducted to show that the tablets could be broken down to accurately deliver such a dose. Therefore, section 4.2 has been updated to state: "Children (under 15kg): Colomycin tablets are not suitable for children under 15kg, because an appropriate dose cannot be delivered from a 1,500,000 unit tablet presentation."
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Updated on 22/03/2010 and displayed until 26/01/2012
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 7 Marketing Authorisation Holder the address has been amended to:
Forest Laboratories UK Limited
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent
DA2 6SL
UK
In section 10 the Date of the Revision of the Text has been updated to:
March 2010
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Updated on 19/08/2009 and displayed until 22/03/2010
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 07-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The following underlined text has been added to section 4.5 Interactions with Other Medicaments and Other Forms of Interaction
4.5 Interactions with Other Medicaments and Other Forms of Interaction
Neurotoxicity has been reported in association with the concomitant use of either curari-form agents or antibiotics with similar neurotoxic effects. Therapy need not be discontinued and reduction of dosage may alleviate symptoms
An in vitro study with colistin sulphate found that it became markedly and irreversibly bound to sucralfate at the pH values found in the gut. This suggests that efficacy for gut decontamination or gastrointestinal infections might be decreased.
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Updated on 20/01/2003 and displayed until 19/08/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 14/02/2002 and displayed until 20/01/2003
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 18/09/2001 and displayed until 14/02/2002
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Reasons for adding or updating:
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Addition of Legal Category
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Updated on 10/08/2001 and displayed until 18/09/2001
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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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