Panadol 500mg 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 16 March 2023
File name
ie-spc-panadol500mg-Separation-clean-230309SKDJ.pdf
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
Change to the MAH from GSK Ireland Limited to Haleon Ireland Limited
Updated on 15 March 2023
File name
Panadol 500 mg film coated tablets compack.pdf consolidated.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to name of manufacturer
Free text change information supplied by the pharmaceutical company
Change to MAH name from GSK Ireland Limited to Haleon Ireland Limited
Updated on 15 March 2023
File name
Panadol 500 mg film coated tablets leaflet.pdf consolidated.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Change to MAH name from GSK Ireland Limited to Haleon Ireland Limited
Updated on 21 September 2022
File name
ie-compack text-clean-Panadol 500 mg-RFI-220511SKDJ.pdf
Reasons for updating
- New PIL for new product
Updated on 20 September 2022
File name
PANADOL_500mg Film coated Tabs_PIL.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 16 September 2022
File name
ie-spc-panadol500mg-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 29 May 2020
File name
ie-mockup-pl-panadol500mg-200320em-proposed-mar2020.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 19 December 2019
File name
ie-pl-500mg 107-1-clean.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.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.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.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.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.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 4.8, 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
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 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