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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: 17/10/2016
SPC Anugesic HC Cream

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 17/10/2016 and displayed until Current
Reasons for adding or 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 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 4.7 - Effects on ability to drive and use machines
  • 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 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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 7 - Marketing authorisation holder
  • 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:   01-Oct-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 1: Heading changed to be in line with QRD template.

Section 2: Heading changed to be in line with QRD template and QRD text regarding full list of excipients has been included.

Section 3: Heading changed to be in line with QRD template.

Section 4.1: Heading changed to be in line with QRD template.

Section 4.2: Changes made in line with QRD template.

Section 4.3: Warning text added regarding hypersensitivity.

Section 4.4: Heading changed to be in line with QRD template.

Section 4.5: Changes made in line with QRD template.

Section 4.6: Changes made in line with QRD template.

Section 4.7: Changes made in line with QRD template.

Section 4.8: Information for reporting of suspected adverse reactions has been added.

Section 4.9: Has been updated to correct the spelling “sulph” to “sulf”.

Section 5.1: Heading changed to be in line with QRD template.

Section 5.2: Heading changed to be in line with QRD template.

Section 5.3: Heading changed to be in line with QRD template.

Section 6.1: List of excipients updated to be in line with QRD template.

Section 6.2: Changes made in line with QRD template.

Section 6.4: Heading changed to be in line with QRD template.

Section 6.5: Heading changed to be in line with QRD template.

Section 6.6: Changes made in line with QRD template.

Section 7: Heading changed to be in line with QRD template.

Section 9: Heading changed to be in line with QRD template.

Section 10: Heading changed to be in line with QRD template.
Updated on 25/05/2011 and displayed until 17/10/2016
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-May-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to section 6.3 (shelf-life)
Updated on 27/04/2011 and displayed until 25/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to sections 2 (Qualitative and Quantitative Composition , 4.3 (Contraindications) and 5.1 (Pharmacodynamic properties).
Updated on 25/09/2007 and displayed until 27/04/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

AU_016

 

SPC

 

2 –    Change of active name from Pramoxine to Pramocaine

4.1 – Change of active name from Pramoxine to Pramocaine

4.9 – Change of active name from Pramoxine to Pramocaine

5.1 - Change of active name from Pramoxine to Pramocaine

10 – Update to date of revision of text

 

 

AU_017

 

6.1– Change of excipient name from BAN’s Sorbitan Monostearate’ to INN 'Sorbitan Stearate

 

AU_018

 

4.9 – Change of excipient name from BAN’s 'Methylene Blue ' to INN 'Methylthioninium ChloridePIL

Updated on 01/09/2006 and displayed until 25/09/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 24/08/2006 and displayed until 01/09/2006
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Updated on 18/08/2003 and displayed until 24/08/2006
Reasons for adding or updating:
  • Improved electronic presentation

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