Anugesic HC Cream
- Name:
Anugesic HC Cream
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/10/16
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
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 17 October 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 17 October 2016 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 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 PIL
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 PIL
Reasons for updating
- New PIL for new product
Updated on 9 June 2011 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 25 May 2011 SmPC
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
Updated on 27 April 2011 PIL
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 SmPC
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
Updated on 11 September 2008 PIL
Reasons for updating
- Change due to user-testing of patient information
- Change to name of manufacturer
Updated on 25 January 2008 PIL
Reasons for updating
- Change from the BAN of the active substance to the rINN
Updated on 25 September 2007 SmPC
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
AU_018
4.9 – Change of excipient name from BAN’s 'Methylene Blue ' to
Updated on 21 September 2007 PIL
Reasons for updating
- Change of special precautions for disposal
- Change to date of revision
Updated on 3 September 2007 PIL
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 1 September 2006 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 24 August 2006 SmPC
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 8 December 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 August 2003 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)