Panadol Cold and Flu Relief 500mg/65mg Film Coated Tablets
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 July 2023
File name
working-ie-spc-panadolcold&flu-clean-230713RE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Updated on 21 July 2023
File name
ie-mockup-Panadol CF leaflet-Haleon-proposed-230713RE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 20 September 2022
File name
ie-mockup-panadol Cold and Flu-proposed-220511SKDJ.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 16 September 2022
File name
ie-spc-panadolcold&flu-PRAC update-clean-220511SKDJ.pdf
Reasons for updating
- 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
Legal category:Supply through general sale
Updated on 03 December 2021
File name
ie-spc-panadolcold&flu-emboss to deboss change-210924SKDJ Approved.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Supply through general sale
Updated on 03 December 2021
File name
ie-mockup-Panadol cold and flu-proposed-embossed to debossed.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
The description of the tablet has been updated from embossed to debossed
Updated on 23 June 2020
File name
ie-spc-panadolcold&flu-105-1-GDSv7-180302EK 19-Jun-20.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.9 - Overdose
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through general sale
Updated on 23 June 2020
File name
ie-mockup-pl-panadolcold&flu-105-1-GDSv7-180302EK.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Updated on 03 September 2018
File name
ie-mockup-leaflet-678-105-1.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 03 September 2018
File name
ie-spc-678-105-1-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Paediatric posology changes
Updated on 21 July 2017
File name
PIL_12146_120.pdf
Reasons for updating
- New PIL for new product
Updated on 21 July 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 21 July 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
An update to section 4.4 to include a warnings and precautions statement concerning risk of metabolic acidosis in patients in glutathione depleted states, such as sepsis.
An update to sections 4.2, 4.4 and 4.9 to include further information relating to hepatotoxicity associated with overdose, and hepatic dysfunction in glutathione depleted states.
An update of the date of revision in section 10.
Updated on 21 July 2017
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 18 April 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Underlying liver disease increases the risk of paracetamol related liver damage.
10. Date of Revision of the Text
April 2017
Updated on 15 April 2016
Reasons for updating
- Change to MA holder contact details
Updated on 10 July 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 7
Marketing Authorisation Holder address updated to:
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Updated on 15 May 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 9 Addition of renewal date
Updated on 14 May 2015
Reasons for updating
- Change to storage instructions
- Addition of information on reporting a side effect.
Updated on 16 December 2013
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 12 December 2013
Reasons for updating
- Change to packaging
Updated on 11 April 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 09 August 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 10 May 2010
Reasons for updating
- 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 4.9 - Overdose
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Addition of the warning in relation to exessive intake of caffeine and update of the warning related to people who have been diagnosed with liver and kidney imparament.
Sectin 4.6
Updated to show information related to pregnancy and breastfeeding for both actives, paracetamol and caffeine.
Sectin 4.8
Adverse events showed in the table by System Organ Class together with the frequences.
Sectin 4.9
Addition of the paragraph related to an overdose with caffeine
Updated on 13 August 2009
Reasons for updating
- Change to date of revision
Updated on 20 August 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Supply through general sale
Updated on 22 June 2007
Reasons for updating
- New PIL for new product
Updated on 20 June 2007
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale