Panadol 500mg Film Coated Tablets *
General Sale: Non-prescription

Updated on 21 September 2022

File name

632b556fc1600.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 September 2022

File name

632a1b1cee3a3.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 16 September 2022

File name

632490b9d7a27.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 29 May 2020

File name

ie-mockup-pl-panadol500mg-200320em-proposed-mar2020_1590763581.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 19 December 2019

File name

ie-pl-500mg 107-1-clean_1576756085.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect

Updated on 18 December 2019

File name

ie-spc-panadol500mg-clean_1576686829.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through general sale

Updated on 05 September 2019

File name

ie-spc-panadol500mg-proposed-clean-optimus-190202em w. PRAC_1567696306.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 05 September 2019

File name

ie-mockup-pl-panadol500mg-optimus-190202em-rfi_1567695858.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 10 July 2019

File name

ie-spc-panadol500mg-PRAC APAP-190708EM-clean_1562768836.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 09 August 2018

File name

ie-spc-clean-107-1_1533854234.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Supply through general sale

Updated on 20 July 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 20 July 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

In section 4.4, addition of warning regarding metabolic acidosis.
In section 4.8, addition of warning regarding serious skin reactions.
In section 10, revision date of text updated.

Updated on 19 July 2017

File name

PIL_16259_81.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 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

4.4 Special warnings and precautions for use


Caution is advised in the administration of paracetamol to patients with moderate or severe renal or severe hepatic impairment. The hazard of overdose is greater in those with moderate and severe liver disease.


Underlying liver disease increases the risk of paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.


10. Date of Revision of the Text

April 2017

Updated on 08 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 16 April 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 2 Addition of information regarding Nipasept Sodium
Section 4.8 Addition of information regarding reporting of suspected adverse reactions
Section 4.9 Addition of risk factors for patients at increased risk of paracetamol toxicity
Section 5.2 Addition of between subject to within-subject variability
Section 9 Date of last renewal added

Updated on 12 March 2015

Reasons for updating

  • New PIL for medicines.ie

Updated on 07 August 2014

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided