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Feldene 5 mg/g Gel

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Piroxicam

    *Additional information is available within the SPC or upon request to the company

Updated on 17 April 2024

File name

Reg SPC FE 17 0 Gel IE CLEAN.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 April 2024

File name

Reg PIL FE 220 gel IE CLEAN.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 13 February 2023

File name

DEC202149050_Reg SPC FE 16_1 Gel IE Clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2022

File name

Reg PIL FE 21_2 gel IE Clean.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 July 2021

File name

DEC202149050_Reg SPC FE 16_1 Gel IE Clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 July 2021

File name

DEC202149050_Reg PIL FE 21_1 gel IE Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 26 March 2021

File name

DEC202120197_Reg SPC FE 15_0 Gel IE-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 March 2021

File name

DEC202120197_Reg PIL FE 19_0 gel IE-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 17 February 2021

File name

DEC202069430_Reg SPC FE 13_3 Gel IE-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2021

File name

DEC202069430_Reg PIL FE 17_2 gel IE-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 17 February 2020

File name

DEC202010522_Reg PIL FE 16_0 gel IE clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 17 February 2020

File name

DEC202010522_Reg SPC FE 12_0 Gel IE clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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 2 – added benzyl alcohol

Section 4.4 – updated propylene glycol and added benzyl alcohol excipient warning

Updated on 09 August 2018

File name

Clean Reg PIL FE 15_0 gel IE.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 09 August 2018

File name

Clean Reg SPC FE 11_1 Gel IE.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number

Updated on 13 September 2016

File name

PIL_12420_789.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 September 2016

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 06 August 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 August 2015

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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 (Topical formulations) (revision date: 4 june 2014), a Type II variation was submitted to update Section 4.6 and Section 5.3 SmPC.  This opportunity was taken to update the SmPC in line with the latest QRD template and some minor editorial updates.

The changes made to the SPC do not impact the PIL but this was taken opportunity to update the reporting of adverse events following name change from IMB to HPRA.

Updated on 04 August 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 15 January 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to Sections 4.4 & 4.8

Updated on 15 January 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 04 July 2013

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.6 updated regarding reversible infertility and increased risk of spontaneous abortion reported in women taking NSAIDs; Section 10 – date of revision updated.

Updated on 03 July 2013

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 02 October 2012

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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 26 September 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 04 February 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 11 May 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

1 - name updated in line with current guidelines to Feldene 5 mg/g Gel

2 - addition of excipients text (Excipient(s): propylene glycol 200 mg/g) in line with current guidelines

6.1 - addition of E numbers to list of excipients, update in name of excipient (Carbopol 980 to Carbomer 980)

6.4 - description expanded: Store in the original tube in order to protect from light

9 - update to date last renewed

10 - update to date last updated

Updated on 06 May 2009

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 13 March 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

A correction has been made to section 6.5 Nature and contents of container, to bring this document in line with the IMB Schedule.

Updated on 03 September 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 August 2007

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8 - addition of post marketing adverse events and section
6.5 - description of the tube end seal

Updated on 18 March 2005

Reasons for 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 August 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 August 2004

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5 - Pharmacological properties
  • Change to section 6.1 - List of excipients
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Addition of legal category

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)