Keflex 500mg Film Coated Tablets

*
Pharmacy Only: Prescription
  • Company:

    Flynn Pharma Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 23 May 2024

File name

ie-spc-500mg-tabs-caps-cl.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 have been updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.

Updated on 23 May 2024

File name

2024-05-22_ie-pl-tabs-caps-cl.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.

Updated on 23 May 2024

File name

2024-05-22_ie-spc-500mg-tabs-caps-cl.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 have been updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.

Updated on 24 June 2022

File name

SmPC 500mg tabs 2022 06 23.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

MAH address change

Updated on 24 June 2022

File name

PIL mockup caps and tabs 2022 06 23.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

MAH address change

Updated on 17 March 2021

File name

Keflex PIL caps and tabs 2021 03 10.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Section 2 :to add warning regarding sodium content. As per the excipient guidelines, this is to confirm that as there is less than 1mmol of sodium per dose, the medicine is considered essentially sodium free

Updated on 17 March 2021

File name

Keflex 500mg tabs SmPC 2021 03 10.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: to add warning regarding sodium content. As per the excipient guidelines, this is to confirm that as there is less than 1mmol of sodium per dose, the medicine is considered essentially sodium free

Updated on 28 August 2019

File name

Irish-SmPC-250mg-caps-approved-230418.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 08 June 2018

File name

Irish-SmPC-500mg-tablets-approved-230418.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

update the ma holder address

Updated on 20 June 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 June 2017

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

General updates in line with QRD requirements

Updated on 20 June 2017

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

General updates in line with QRD requirements

Updated on 20 July 2012

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 July 2012

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided