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Bayer Limited
The Atrium, Blackthorn Road, Dublin 18,
Telephone: +353 1 2999 313
Fax: +353 1 2061 456
Summary of Product Characteristics last updated on medicines.ie: 08/06/2010
SPC CanOral 150mg Capsule

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 08/06/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   15-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 2 (qualitative and quantitative composition), the following changes have been made:

BEFORE:
'Each capsule contains Fluconazole 150 mg
For excipients, see 6.1'

AFTER:
'Each hard capsule contains Fluconazole 150 mg
Excipients: each hard capsule contains 141.0mg of lactose monhydrate
For a full list of excipients, see section  6.1'

Section 6.4 (special precautions for storage) has been updated to read as follows:

BEFORE:
'No special precautions for storage'

AFTER:
'This medicinal product does not require any special storage conditions'

The following change has been made to section 6.6 (special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product):

BEFORE:
'Not applicable'

AFTER:
'No special requirements'
Updated on 04/01/2010 and displayed until 08/06/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-Nov-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 6.1 was updated to remove Soya lecithin and Antifoam DC1510 as the contents of the printing ink.

Section 10 was updated to November 2009
Updated on 02/06/2009 and displayed until 04/01/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Fluconazole