Diaclide MR 60mg modified-released tablets
*Company:
Mylan IRE Healthcare 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 12 March 2025
File name
ie-spc-pt1203-v015-rtq-clean.pdf
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 March 2025
File name
ie-pl-pt1203-v015-rtq-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 28 November 2024
File name
ie-spc-pt1203-MAHT-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 November 2024
File name
ie-pl-pt1203-MAHT-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 01 December 2022
File name
ie-pl-pt1203-clean-v012g.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 01 December 2022
File name
ie-SPC-pt1203-clean-v012g.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 March 2022
File name
ie-pl-pt1203-clean-v010g.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 16 November 2021
File name
ie-pil-pt1203-clean-v009.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 16 November 2021
File name
ie-spc-pt1203-clean-v009.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)
Updated on 15 January 2021
File name
ie-SPC-pt1203-clean-v008.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:Product subject to medical prescription which may be renewed (B)
Updated on 07 March 2019
File name
Diaclide 60mg PIL.pdf
Reasons for updating
- New PIL for new product
Updated on 07 March 2019
File name
Diaclide 60mg SPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1