Metatone Tonic *
Pharmacy Only: Non-prescription

Updated on 22 March 2021

File name

ie-mockup-leaflet_1616417051.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_1616416836.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_1591628906.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 08 June 2020

File name

ie-spc approved 3rd May 2019_1591628739.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.

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.

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