Feldene 5 mg/g Gel * Pharmacy Only: Prescription
Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 17 February 2022
File name
Reg PIL FE 21_2 gel IE Clean_1645104089.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_1626786851.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_1626786806.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_1616757737.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_1616757683.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_1613552370.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_1613552320.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_1581955239.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_1581955009.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_1533808707.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_1533808760.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
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
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)