Anugesic HC Cream *

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 17 October 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 October 2016

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 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

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 11 October 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • 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
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 11 October 2016

File name

PIL_8939_711.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 June 2011

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 25 May 2011

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 6.3 (shelf-life)

Updated on 27 April 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 27 April 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

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 11 September 2008

Reasons for updating

  • Change due to user-testing of patient information
  • Change to name of manufacturer

Updated on 25 January 2008

Reasons for updating

  • Change from the BAN of the active substance to the rINN

Updated on 25 September 2007

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 21 September 2007

Reasons for updating

  • Change of special precautions for disposal
  • Change to date of revision

Updated on 03 September 2007

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to marketing authorisation holder address
  • Change to date of revision
  • Change to storage instructions

Updated on 01 September 2006

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 24 August 2006

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 08 December 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 August 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)