Excedrin 250 mg /250 mg /65 mg film-coated tablets

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Pharmacy Only: Non-prescription

Updated on 03 September 2024

File name

Approved excedrin leafelt 27 September 2024.pdf

Reasons for updating

  • Change to further information section

Free text change information supplied by the pharmaceutical company

Change to Luxemburg and Belgium name

Updated on 10 July 2024

File name

MASTER-ie-text-PIL-excedrin-clean-approved-08Jul2024.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 09 July 2024

File name

MASTER-ie-spc-excedrin-clean-approved-08Jul2024.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 09 July 2024

File name

MASTER-ie-mockup-PIL-excedrin-clean-approved-08Jul2024.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 25 April 2023

File name

ie-working-spc-excedrin-typeIAIN-Separation-clean-230208SKDJ.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to MAH name

Updated on 25 April 2023

File name

ie-pl-excedrin-Haleon Name change-implemented 3 March 2023.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Update to MAH name

Updated on 18 January 2023

File name

ie-working-PIL-excedrin-Type IB-PRAC update-Flucloxacillin-approved 12-01-23 (003).pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 18 January 2023

File name

ie-working-spc-excedrin-typeIB-PRAC update-Flucloxacillin-approved 12-01-23 (004).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 pharmacy only

Updated on 18 January 2023

File name

ie-working-spc-excedrin-typeIA-CRSF-220907SKDJ-clean.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 pharmacy only

Updated on 29 September 2022

File name

ie-working-spc-excedrin-typeIA-CRSF-220907SKDJ-clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of CRSF blister packaging.

Updated on 04 September 2020

File name

ie-pl-excedrin-safety update - II-043-G approved 4th Sept 2020.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects

Updated on 04 September 2020

File name

ie-spc-excedrin-safety update- II-43-G approved 4th Sept 2020.pdf

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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 6.6 - Special precautions for disposal and other handling

Legal category:Supply through pharmacy only

Updated on 28 March 2019

File name

ie-mockup-pl-61(3)Famar-190204EM.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 04 January 2019

File name

ie-spc-excedrin-proposed-clean-dec2018-medie.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 04 January 2019

File name

ie-spc-excedrin-proposed-clean-dec2018-medie.pdf

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 06 June 2017

File name

PIL_16707_876.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 June 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 03 May 2016

Reasons for updating

  • New PIL for medicines.ie