Metatone Tonic
*Company:
Chefaro Ireland DACStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 March 2021
File name
ie-mockup-leaflet.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 22 March 2021
File name
ie-spc-clean-15-Feb-2021.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 08 June 2020
File name
ie-mockup-pl-0000.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 08 June 2020
File name
ie-spc approved 3rd May 2019.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Supply through pharmacy only
Updated on 25 April 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 25 April 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
7 MARKETING AUTHORISATION HOLDER
Chefaro Ireland DAC, Treasury Building, Lower Grand Canal Street, Dublin 2, Ireland.
Chefaro Ireland DAC, Treasury Building, Lower Grand Canal Street, Dublin 2, Ireland.
Updated on 21 April 2017
File name
PIL_15821_712.pdf
Reasons for updating
- New PIL for new product
Updated on 21 April 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 15 June 2015
Reasons for updating
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
section 4.8 - typographical correction of symbols in relation to frequency classification
Updated on 12 June 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.4 (Special Warnings) - addition of sodium warning for patients on a controlled sodium diet.
4.8 (Undesirable Effects) - addition of statement that Metatone contains actives with well established safety profile and has limited adverse events when taken correctly; addition of adverse events frequency classification statement, and addition of the following adverse events Hypersensitivity, Abdominal discomfort, nausea, vomiting, diarrhoea, constipation, Allergic skins reactions and Malaise (all frequency not known); addition of adverse event report statement for Ireland.
10 (Date of Revision of the Text) - changed to May 2015.
4.8 (Undesirable Effects) - addition of statement that Metatone contains actives with well established safety profile and has limited adverse events when taken correctly; addition of adverse events frequency classification statement, and addition of the following adverse events Hypersensitivity, Abdominal discomfort, nausea, vomiting, diarrhoea, constipation, Allergic skins reactions and Malaise (all frequency not known); addition of adverse event report statement for Ireland.
10 (Date of Revision of the Text) - changed to May 2015.
Updated on 12 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 29 August 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 6.3 (shelf life): the shelf life of the 300ml presentation is extended from 24 months to 36 months (aligning it with the 500ml presentation)
Updated on 23 August 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- SPC retired pending re-submission
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 7 (Marketing Authorisation Holder), the address of the MAH has been updated.
Updated on 20 August 2013
Reasons for updating
- New PIL for medicines.ie
Updated on 30 August 2012
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
None provided