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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
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC Feldene 20 mg capsules

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 13/07/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Jul-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows: Section 4.4 wording has been updated in line with the CDS

Updated on 13/08/2015 and displayed until 13/07/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Aug-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows

Following an update to Pfizer’s Internal Core Data Sheet for Piroxicam, Type II variation was submitted to update Sections 4.4 & 4.8 of the Summary of Product Characteristics for Feldene Capsules to include hepatic events updates.

Updated on 10/02/2014 and displayed until 13/08/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Jan-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to:

Section 4.4: Updated regarding gastrointestinal effects and poor metabolizers of CYP2C9 substrates;
Section 4.8:
Interstitial nephritis, nephrotic syndrome, glomerulonephritis and renal failure added as ADRs and details regarding reporting of side effects added; Section 5.2: Pharmacogenetics regarding CYP2C9 added.

Updated on 13/09/2013 and displayed until 10/02/2014
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Sep-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.6 - updated in relation to reversible infertility and increased risk of spontaneous abortion reported in women taking NSAIDs; Section 4.8 - ‘female fertility decreased’ added as an adverse reaction; section re-formatted (as table) and frequencies added for all ADRs

Updated on 02/01/2013 and displayed until 13/09/2013
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   03-Dec-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.7 of the SPC to be in line with Section 2 subsection ‘Driving and using machinery’ of the PIL
Updated on 03/10/2012 and displayed until 02/01/2013
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

 sections 4.4 & 4.8 updated with PhVWP wording regarding SJS and TEN;
section 6.1 formatting amended for 10mg only;
section 10 date of revision updated

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Active Ingredients

 
   Piroxicam