Feldene 5 mg/g Gel
- Name:
Feldene 5 mg/g Gel
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/08/18
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Pfizer Healthcare Ireland
Company Products
When a pharmaceutical company changes any document, 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 9 August 2018 PIL
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 9 August 2018 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 13 September 2016 PIL
Reasons for updating
- Change to date of revision
- Improved electronic presentation
Updated on 6 August 2015 SmPC
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 6 August 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 August 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 15 January 2014 PIL
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 15 January 2014 SmPC
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 4 July 2013 SmPC
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 3 July 2013 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 2 October 2012 SmPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 4 February 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 11 May 2009 SmPC
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 6 May 2009 PIL
Reasons for updating
- Change to storage instructions
- Change to date of revision
- Correction of spelling/typing errors
Updated on 13 March 2008 SmPC
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 3 September 2007 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 29 August 2007 SmPC
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 SmPC
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 SmPC
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 9 August 2004 SmPC
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 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)