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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 12/01/2012
SPC DIFLUCAN CAPSULES 150MG

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 12/01/2012 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Nov-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Correction of typo.
Updated on 18/03/2011 and displayed until 12/01/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Feb-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company


Section 4.3 – Contraindications

Section 4.5 – Interaction with other medicinal products and other sforms of interaction

Chnage to section 4.6 – Pregnancy and lactation

Change to 4.7 – Effects on ability to drive and use machines

Changes to section 4.8 – Undesirable efffects
Updated on 24/02/2011 and displayed until 18/03/2011
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SmPC  (section 9 and 10 has been updated)
Updated on 25/03/2008 and displayed until 24/02/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

4.4 – addition of sucrose warning

4.5 – addition of interaction with fluvastatin
Updated on 17/01/2008 and displayed until 25/03/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

6.1 – updated list of excipients to include composition of replacement and alternative inks used for marking/imprinting capsules. 

Updated on 18/05/2007 and displayed until 17/01/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

4.5 – Change from BAN to INN, Pentobarbitone to Pentobarbital

5.1 – Change from BAN to INN, Cyclosporin to Ciclosporin
Updated on 05/09/2006 and displayed until 18/05/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • 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:   04/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 1 - change of name format
Section 2 - change of name format and clearer wording
Section 4.5 - the active replaced with the trade name throughout
Section 4.8 - formatting
Section 6.1 - change from colloidal silicon dioxide to colloidal anhydrous silica and laurilsulfate to lauryl sulphate, details about the printing ink also added
Section 10 - newer date added
Updated on 29/04/2004 and displayed until 05/09/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 27/06/2003 and displayed until 29/04/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Fluconazole