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Dona 1500mg Powder for Oral Solution *
Pharmacy Only: Non-prescription

Updated on 21 December 2020

File name

ie-spc-donasachets-1500mg -IBexcipients-clean (1)_1608549947.pdf

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 21 December 2020

File name

ie-pl-donasachets-1500-mg-IBexcipients-clean_1608549582.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 15 August 2018

File name

ie-pl-donasachets-mahtransfer-clean_1534341103.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 August 2018

File name

ie-spc-donasachets-mahtransfer-clean_1534341156.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:Supply through pharmacy only

Updated on 29 May 2018

File name

DONA_Sachets_SmPC_May_2018.docx

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5: information added with regards possible interactions with oral vitamin K antagonists

In section 10: date of revision changed

Updated on 28 July 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 28 July 2016

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 5.3: section revised to harmonise with Dona caspules

Updated on 28 July 2016

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

In section 5.3: section revised to harmonise with Dona caspules

Updated on 31 March 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

$0In section 2:    A slight amendment to text$0$0In section 4.2: A slight amendment to text$0$0In section 4.3: A new contraindication has been added forpatients with a rare hereditary problems of fructose intolerance.$0$0In section 4.5: Information has been added in relation tosteroidal or non-steroidal analgesic or anti-inflammatory agents.$0$0In section 4.7: Information regarding CNS and motor systemsadded.$0$0In section 4.8: Additional undesirable effects added.Adverse Reaction reporting statement added.$0$0In section 4.9: Information added to overdose$0$0In section 5.1: Pharmacotherapeutic group added. Mechanismof action added. Pharmacodynamic effects added. Clinical efficacy andtolerability information added.$0$0In section 5.2: Information added regarding absorption,distribution, metabolism, excretion and special population. Also informationadded regarding children and adolescents and older people.$0$0In section 5.3: Preclinical Safety Data added$0$0In section 10: Date of revision changed$0

Updated on 31 March 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines

Free text change information supplied by the pharmaceutical company

$0In section 2:    A slight amendment to text$0$0In section 4.2: A slight amendment to text$0$0In section 4.3: A new contraindication has been added forpatients with a rare hereditary problems of fructose intolerance.$0$0In section 4.5: Information has been added in relation tosteroidal or non-steroidal analgesic or anti-inflammatory agents.$0$0In section 4.7: Information regarding CNS and motor systemsadded.$0$0In section 4.8: Additional undesirable effects added.Adverse Reaction reporting statement added.$0$0In section 4.9: Information added to overdose$0$0In section 5.1: Pharmacotherapeutic group added. Mechanismof action added. Pharmacodynamic effects added. Clinical efficacy andtolerability information added.$0$0In section 5.2: Information added regarding absorption,distribution, metabolism, excretion and special population. Also informationadded regarding children and adolescents and older people.$0$0In section 5.3: Preclinical Safety Data added$0$0In section 10: Date of revision changed$0

Updated on 14 January 2016

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

Updated on 14 January 2016

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided