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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 10mg 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 4.7 - Effects on ability to drive and use machines
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 02/10/2012 and displayed until 02/01/2013
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 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Sep-2012
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

Updated on 12/07/2011 and displayed until 02/10/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.3 updated with excipient contraindication
Updated on 24/06/2010 and displayed until 12/07/2011
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



In section 5.2 - addition of information on the metabolism of piroxicam
In section 10 - revision of date last updated

Updated on 09/03/2010 and displayed until 24/06/2010
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Feb-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 6.5 - 10mg changed from 56 to 30 capsules pack, 20mg changed from 28 to 30 capsules pack

Section 10 - date of revision of text updated

Updated on 14/04/2009 and displayed until 09/03/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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:   04/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 1 - update to name to include full pharmaceutical form in line with SPC Guidelines

Section 2 - inclusion of lactose monohydrate quantity

Sections 4.1 - 4.6, 4.8, 4.9, 5.1, 5.2 - administrative updates including changing 'FELDENE' to 'Feldene'

Section 6.5 - widened description of container to include outer cardboard carton

Section 6.6 - update to heading in line with SPC guidelines

Section 9 - update to date last renewed

Section 10 - update to date last updated

Updated on 21/11/2007 and displayed until 14/04/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 4.8 - Undesirable effects
  • 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

4.1 – deletion of acute indications, only indicated as second line treatment

4.2 – max daily dose reduced to 20mg, only to be prescribed by physicians with relevant experience, consider need for concomitant PPI, advice on regular treatment review, minimise side effects by giving minimum does for shortest duration necessary

4.3 – contraindications strengthened to include history of gastro-intestinal ulceration, bleeding, perforation or GI conditions that predispose to bleeding, current GI disorders, concomitant use with NSAIDs, including COX-2s, aspirin at analgesic dose, anticoagualnts, history of previous serious allergic drug reaction of any type (esp. serious skin reactions, moderate or sever heart failure

4.4 – extensive changes to strengthen advice about GI complications, serious skin reactions, CV risk, appropriate monitoring, affect on fertility

4.5 – updated information about aspirin & other NSAIDs, anticoagulants, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs), corticosteroids

4.8 – addition of side effects dyspepsia, exacerbation of colitis and Crohn’s disease and gastritis. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Data suggest that use of some NSAIDs may be associated with a small increased risk of arterial thrombotic events

6.1 – format update to advert SmPC (not related to variation)

Updated on 08/09/2006 and displayed until 21/11/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   09/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Reason for Submission: Change to section 3 - pharmaceutical form, Change to section 6.1 - List of Excipients
Updated on 01/03/2006 and displayed until 08/09/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
Updated on 26/08/2005 and displayed until 01/03/2006
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Addition of legal category
Updated on 27/06/2003 and displayed until 26/08/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Piroxicam