Keflex 250mg Hard Capsules
*Company:
Flynn Pharma LtdStatus:
UpdatedLegal 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 03 June 2025
File name
2025-06-02_ie-pl-tabs-caps-clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 03 June 2025
File name
2025-06-02_ie-spc-250mg-caps-clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 May 2024
File name
ie-spc-250mg-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-250mg-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 250mg caps 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
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Section 2: 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 PIL caps and tabs 2021 03 10.pdf
Reasons for updating
- New PIL for new product
Updated on 17 March 2021
File name
Keflex 250mg caps 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
Sectionto 4.4: 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-250mg-caps-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 MA holder address details
Updated on 14 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 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
Updated on 14 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
Updated on 16 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
Updated on 16 July 2012
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
Flynn Pharma Ltd
Address:
5th Floor, 40 Mespil Road, Dublin 4, IRELAND, D04 C2N4Medical Information E-mail:
medinfo@flynnpharma.comMedical Information Direct Line:
+44 (0)1438 727822