Dona 500mg Capsules
*Company:
Mylan IRE Healthcare LtdStatus:
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 26 January 2021
File name
ie-spc-donacaps-500mg-IBexcipients-clean-Dec2020.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.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.pdf
Reasons for updating
- New PIL for new product
Updated on 15 August 2018
File name
ie-spc-donacaps-mahtransfer-clean.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
- New SPC for new product
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 changedUpdated 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 changedUpdated 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
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
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
Updated on 25 November 2015
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1