Dona 500mg Capsules

Product Information *

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through pharmacy only

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 26 January 2021

File name

ie-spc-donacaps-500mg-IBexcipients-clean-Dec2020_1611669576.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
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 26 January 2021

File name

ie-pl-donacaps-500mg-IBexcipients-clean-Dec2020_1611669536.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 15 August 2018

File name

ie-pl-donacaps-mahtransfer-clean_1534341414.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 August 2018

File name

ie-spc-donacaps-mahtransfer-clean_1534341472.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 08 May 2018

File name

Dona_500mg_Capsules_SmPC_April_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

Updated on 29 July 2016

Reasons for updating

  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 2: Very minor text change

In section 4.2: Minor text changes and method of administration added.

In section 4.3: Minor text addition.

In section 4.4: Information regarding the presence of other joint disease added.

In section 4.5: Information regarding steroidal or non-steroidal analgesic or anti-inflammatory agents added.

In section 4.7: Information regarding effects on the ability to drive added: no important effects on the CNS or motor system known.

In section 4.8: Addition of some undesirable effects and removal of some undesirable effects. Addition of adverse reaction reporting statement.

In section 4.9: Addition of information.

In section 5.1: Pharmacotherapeutic group added. Complete rewrite of section.

In section 5.2:  Information added regarding absorption, distribution, metabolism, excretion and special populations.

In section 5.3: Complete rewrite of section

In section 10: Date of revision has changed

Updated on 29 July 2016

Reasons for updating

  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Free text change information supplied by the pharmaceutical company

In section 2: Very minor text change

In section 4.2: Minor text changes and method of administration added.

In section 4.3: Minor text addition.

In section 4.4: Information regarding the presence of other joint disease added.

In section 4.5: Information regarding steroidal or non-steroidal analgesic or anti-inflammatory agents added.

In section 4.7: Information regarding effects on the ability to drive added: no important effects on the CNS or motor system known.

In section 4.8: Addition of some undesirable effects and removal of some undesirable effects. Addition of adverse reaction reporting statement.

In section 4.9: Addition of information.

In section 5.1: Pharmacotherapeutic group added. Complete rewrite of section.

In section 5.2:  Information added regarding absorption, distribution, metabolism, excretion and special populations.

In section 5.3: Complete rewrite of section

In section 10: Date of revision has changed

Updated on 29 July 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 27 November 2015

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 10: the date of revision has been corrected

Updated on 27 November 2015

Reasons for updating

  • 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 10: the date of revision has been corrected

Updated on 25 November 2015

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 25 November 2015

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided