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Dona 1500mg Powder for Oral Solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/08/18

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Summary of Product Characteristics last updated on medicines.ie: 15/8/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15 August 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 August 2018

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

Updated on 29 May 2018

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 PIL

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 28 July 2016 SPC

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

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 31 March 2016 PIL

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 31 March 2016 SPC

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 14 January 2016 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 14 January 2016 SPC

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